Revolution Medicines, Inc. (RVMD) 2026 Q2 法說會逐字稿

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  • Operator

    Operator

  • Good day and thank you for standing by. Welcome to the Revolution Medicines Q2 2026 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Ryan Asay, Senior Vice President, Corporate Affairs. Please go ahead.

    大家好,感謝您稍候。歡迎參加 Revolution Medicines 2026 年第二季財報電話會議。(接線員指示) 請注意,今天的會議將被錄音。現在我想把會議交給今天的第一位講者,Ryan Asay,企業事務資深副總裁。請開始。

  • Ryan Asay - Senior Vice President, Corporate Affairs

    Ryan Asay - Senior Vice President, Corporate Affairs

  • Thank you, and welcome, everyone, to the second quarter 2026 earnings call. Joining me on today's call are Dr. Mark Goldsmith, Revolution Medicines' Chairman and Chief Executive Officer; Dr. Alan Sandler, our Chief Development Officer; and Jack Anders, our Chief Financial Officer; Dr. Wei Lin, our Chief Medical Officer; and Anthony Mancini, our Chief Global Commercialization Officer, will join us for the Q&A portion of today's call.

    謝謝,並歡迎各位參加 2026 年第二季財報電話會議。今天與我一同出席的有 Revolution Medicines 董事長兼執行長 Mark Goldsmith 博士;我們的開發長 Alan Sandler 博士;以及我們的財務長 Jack Anders;我們的醫務長 Wei Lin 博士;以及我們的全球商業化長 Anthony Mancini,將在今天電話會議的問答環節加入。

  • We would like to inform you that certain statements we make during this call will be forward-looking because such statements deal with future events and are subject to many risks and uncertainties. Actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the US Securities and Exchange Commission.

    我們想提醒各位,我們在本次電話會議中所做的某些陳述將屬於前瞻性陳述,因為這些陳述涉及未來事件,並受多項風險與不確定性影響。實際結果可能與前瞻性陳述中的內容存在重大差異。如需完整了解這些風險與不確定性,請查閱我們向美國證券交易委員會提交的 Form 10-K 年度報告及 Form 10-Q 季度報告。

  • This afternoon, we released financial results for the quarter ended June 30, 2026, and recent corporate updates. The press release and updated corporate presentation are available on the Investors section of our website at revmed.com.

    今天下午,我們發布了截至 2026 年 6 月 30 日止季度的財務結果以及近期公司最新進展。新聞稿與更新後的公司簡報可於我們網站 revmed.com 的投資人專區取得。

  • With that, I'll turn the call over to Dr. Mark Goldsmith, Revolution Medicines' Chairman and Chief Executive Officer. Mark?

    接下來,我將把電話會議交給 Revolution Medicines 董事長兼執行長 Mark Goldsmith 博士。Mark?

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Ryan, and thanks to everyone for joining us this afternoon. I'll begin today's call with initial remarks focused primarily on pancreatic cancer, and then Dr. Sandler will provide highlights of recent results and plans in non-small cell lung cancer. Jack Anders will then summarize our second quarter financial results before I share some closing comments and open the call to questions and answers.

    謝謝你,Ryan,也感謝各位今天下午加入我們。我將以胰臟癌為主題先做開場說明,接著 Sandler 博士將就非小細胞肺癌的近期結果與計畫提供重點摘要。之後 Jack Anders 將總結我們第二季的財務結果,然後我會做一些結語並開放問答。

  • 2026 is proving to be a transformational year for Revolution Medicines with substantial progress in many dimensions, supporting our mission to revolutionize treatment for patients with RAS-addicted cancers globally through the discovery, development and delivery of innovative targeted medicines. We've continued to build on strong momentum in pancreatic cancer, reinforced by compelling results from RASolute 302, our recently completed global Phase 3 study in patients with previously treated metastatic disease. Catalyzed by the unprecedented clinical results, we quickly expanded availability to patients through our FDA-cleared expanded access program, advanced regulatory activities in support of potential approvals, strengthened our commercial readiness globally and continue to expand our broad pioneering R&D pipeline targeting RAS-driven cancers.

    2026 年正逐步成為 Revolution Medicines 的轉型之年,我們在多個面向取得重大進展,支持我們的使命:透過發現、開發與提供創新標靶藥物,為全球 RAS 依賴型癌症患者帶來治療革新。我們在胰臟癌領域持續累積強勁動能,並由 RASolute 302 的具說服力結果進一步強化;該研究為我們近期完成的全球第三期試驗,對象為既往接受治療的轉移性疾病患者。在前所未有的臨床結果帶動下,我們迅速透過 FDA 核准的擴大使用計畫(expanded access program)擴大患者可近性,推進支持潛在核准的法規活動,強化全球商業化上市準備,並持續擴展我們廣泛且具開創性的研發產品線,以鎖定 RAS 驅動型癌症。

  • I'd like to spend a few more minutes reviewing some of these activities in more detail. First, at the American Society of Clinical Oncology, or ASCO, Dr. Brian Wolpin presented the full results from RASolute 302, which were also published simultaneously in The New England Journal of Medicine. The data demonstrated paradigm-changing clinical outcomes with daraxonrasib monotherapy in patients with previously treated metastatic pancreatic cancer, including statistically significant and clinically meaningful improvements in overall survival, progression-free survival and patient-reported quality of life indicators compared to chemotherapy, along with a manageable safety and tolerability profile. Second, based on these and earlier results, we believe daraxonrasib represents a major advance for patients facing one of the most difficult-to-treat cancers, and we are moving with urgency to make this potential new treatment available to eligible patients as quickly as possible.

    我想再花幾分鐘更詳細回顧其中一些工作。首先,在美國臨床腫瘤學會(ASCO)年會上,Brian Wolpin 博士發表了 RASolute 302 的完整結果,並同步刊登於《新英格蘭醫學雜誌》。數據顯示,daraxonrasib 單藥治療在既往接受治療的轉移性胰臟癌患者中帶來改變典範的臨床結果:相較於化療,在總存活期、無惡化存活期以及患者回報生活品質指標方面,均達到具統計顯著性且具臨床意義的改善,同時安全性與耐受性特徵可控。第二,基於這些以及更早期的結果,我們相信 daraxonrasib 對於面臨最難治療癌症之一的患者而言是一項重大進展,因此我們正以最高急迫性推動,盡可能快速讓符合條件的患者取得這項潛在新療法。

  • In particular, since announcing our expanded access program shortly after disclosing top line results from RASolute 302, we've made significant progress establishing access through healthcare providers across the United States. It has been deeply gratifying to activate sites participating in the program in almost all 50 US states and Puerto Rico, including both academic cancer centers and community oncology practices with many additional sites still coming online to begin treating patients through the program. To date, our team has approved greater than 90% of reviewed requests and has provided daraxonrasib on behalf of more than 2,000 eligible patients.

    特別是,自我們在揭露 RASolute 302 主要結果後不久宣布擴大使用計畫以來,我們在美國各地透過醫療照護提供者建立可近性方面已取得顯著進展。能在幾乎全美 50 州及波多黎各啟動參與該計畫的據點,令我們深感欣慰;其中包括學術癌症中心與社區腫瘤診所,且仍有更多據點正陸續上線,準備透過該計畫開始為患者提供治療。截至目前,我們團隊已核准超過 90% 的已審查申請,並已代表超過 2,000 名符合條件的患者提供 daraxonrasib。

  • Our teams continue working closely with investigators, healthcare providers, patient advocacy organizations and regulators to make this possible, and we're proud of the progress so far on behalf of patients. I'm also very pleased to note that our new drug application for daraxonrasib in pancreatic cancer has been accepted for review by the US Food and Drug Administration. We continue to engage constructively with the FDA as they review this application. We're also making progress with additional regulatory authorities around the world.

    我們的團隊持續與研究者、醫療照護提供者、病友倡議組織以及監管機構密切合作,以促成上述工作;我們也為目前代表患者所取得的進展感到自豪。我也非常高興指出,我們針對 daraxonrasib 用於胰臟癌的新藥申請(NDA)已獲美國食品藥物管理局受理審查。在 FDA 審查該申請期間,我們持續以建設性的方式與其互動。我們也正與全球其他監管機關推進相關法規進程。

  • The European Medicines Agency, or EMA, recently announced that it had designated daraxonrasib as a high priority under EMA's Cancer Medicines Pathfinder project based on its potential to address a high unmet medical need and that it has started a phase review of daraxonrasib with the goal of accelerating assessment by evaluating the data as they become available ahead of the submission of a full marketing authorization application. We look forward to continuing collaborative interactions with the EMA and other health authorities around the world as we work to bring daraxonrasib to patients as quickly as possible.

    歐洲藥品管理局(EMA)近期宣布,基於 daraxonrasib 具備滿足高度未被滿足醫療需求的潛力,已在 EMA 的 Cancer Medicines Pathfinder 專案下將 daraxonrasib 指定為高優先級,並已啟動分階段審查(phase review),目標是在完整上市許可申請提交前,隨資料可得即先行評估,以加速審查進度。我們期待在推動 daraxonrasib 盡可能快速提供給患者的過程中,持續與 EMA 及全球其他衛生主管機關進行合作互動。

  • Third, we continue preparing for a successful launch. In the US, our medical affairs organization has been in the field for over a year and continues to actively engage the oncology community through scientific exchange. We have also built the commercial infrastructure needed to support launch. Our sales organization is in place. Our field access team is operational, and our OnPath Patient Services Program, commercial supply, and distribution network are ready.

    第三,我們持續為成功上市做準備。在美國,我們的醫藥事務團隊已在第一線運作超過一年,並持續透過科學交流積極與腫瘤領域社群互動。我們也已建立支持上市所需的商業化基礎設施。我們的銷售團隊已就位。我們的市場准入外勤團隊已開始運作,而我們的 OnPath 病患服務計畫、商業供應與配送網絡也已準備就緒。

  • We are well positioned to serve patients with pancreatic cancer from day one. Internationally, we continue to build our launch capabilities at an accelerating pace, positioning us to support future commercialization across key markets. Subject to regulatory approvals, we believe we are well positioned to execute a strong launch and deliver daraxonrasib to patients quickly and broadly. Fourth, with our commitment to pancreatic cancer extending well beyond previously treated disease, we continue prosecuting a comprehensive development strategy involving multiple RAS(ON) inhibitors across lines of treatment. With daraxonrasib, enrollment continues in the RASolute 303 and 304 Phase 3 programs in the first-line metastatic and adjuvant settings, respectively.

    我們已做好準備,從上市第一天起就能服務胰臟癌患者。在國際市場方面,我們持續以加速的步伐建置上市能力,使我們能在關鍵市場支持未來的商業化。在取得監管核准的前提下,我們相信我們已具備良好條件執行強勁的上市推進,並快速且廣泛地將 daraxonrasib 提供給患者。第四,基於我們對胰臟癌的承諾遠不止於既往治療後的疾病,我們持續推進一套全面的開發策略,涵蓋多種 RAS(ON) 抑制劑並跨越不同治療線別。就 daraxonrasib 而言,RASolute 303 與 304 兩項第三期計畫仍在持續收案,分別針對第一線轉移性與輔助治療(adjuvant)情境。

  • With zoldonrasib, our RAS(ON) G12D-selective covalent inhibitor, the RASolute 305 Phase 3 trial in first-line metastatic pancreatic cancer is also enrolling and treating patients. Further, we recently initiated RASolute 309, evaluating the novel RAS(ON) inhibitor doublet of daraxonrasib plus zoldonrasib in the first-line treatment setting. These trials are supported by strong clinical data and continue to generate significant interest from investigators and patients around the world who recognize both the unmet needs and the underlying scientific rationale for these treatment strategies.

    就 zoldonrasib(我們的 RAS(ON) G12D 選擇性共價抑制劑)而言,RASolute 305 這項針對第一線轉移性胰臟癌的第三期試驗也正在收案並治療患者。此外,我們近期啟動了 RASolute 309,評估新型 RAS(ON) 抑制劑雙聯方案 daraxonrasib 加 zoldonrasib,用於第一線治療情境。這些試驗均由強勁的臨床數據所支持,並持續引發全球研究者與患者的高度興趣;他們同時認知到未被滿足的需求,以及這些治療策略背後的科學理據。

  • At last month's European Society for Medical Oncology's Gastrointestinal Cancers Congress, or ESMO GI, we presented new pancreatic cancer data for zoldonrasib that reinforced its compelling profile and the breadth of our development strategy in pancreatic cancer specifically, including the differentiated first-line treatment approaches underlying the RASolute 305 and 309 trials. In one study reported at ESMO GI, zoldonrasib, combined with standard of care chemotherapy showed compelling preliminary antitumor activity in first-line treatment of patients with RAS G12D pancreatic cancer, including objective response rates of 82% and 61% and disease control rates of 96% and 90% in combination with modified FOLFIRINOX or gemcitabine plus nab-paclitaxel, respectively. Longer follow-up will further establish the durability profiles for these regimens. These combinations also demonstrated favorable safety and tolerability profiles with treatment-related adverse events broadly consistent with the established profiles of each respective chemotherapy component. These encouraging findings strongly support the global pivotal Phase 3 RASolute 305 study of the zoldonrasib plus chemotherapy in first-line treatment of patients with RAS G12D pancreatic cancer.

    在上個月的歐洲腫瘤內科學會胃腸道癌症大會(European Society for Medical Oncology's Gastrointestinal Cancers Congress,簡稱 ESMO GI)上,我們發表了 zoldonrasib 的胰臟癌新數據,進一步強化其具吸引力的特性,以及我們在胰臟癌領域(特別是胰臟癌)開發策略的廣度,其中包括支撐 RASolute 305 與 309 試驗之差異化一線治療策略。在 ESMO GI 報告的一項研究中,zoldonrasib 與標準治療化療合併使用,於 RAS G12D 胰臟癌患者的一線治療中展現具吸引力的初步抗腫瘤活性;在分別與改良版 FOLFIRINOX 或吉西他濱(gemcitabine)加白蛋白結合型紫杉醇(nab-paclitaxel)合併時,客觀反應率分別為 82% 與 61%,疾病控制率分別為 96% 與 90%。更長期的追蹤將進一步確立這些療法的持久性特徵。這些合併療法亦顯示良好的安全性與耐受性特徵,治療相關不良事件大致與各化療組成成分既有的已知特徵一致。這些令人鼓舞的發現強力支持全球關鍵性第三期 RASolute 305 研究,該研究評估 zoldonrasib 加化療作為 RAS G12D 胰臟癌患者一線治療。

  • In a second study reported at ESMO GI, the RAS(ON) inhibitor doublet of daraxonrasib plus zoldonrasib demonstrated compelling preliminary clinical activity in second and third line or later treatment of patients with RAS G12D pancreatic cancer, including objective response rates of 50% and 47% and disease control rates of 97% and 90%, respectively, observations that are consistent with earlier preclinical studies. Earlier indicators of durability for this combination are also compelling, showing median progression-free survival of 9.6 months and 7.6 months in patients in second and third-line treatment or later, respectively. Median overall survival in the second-line setting was not yet reached, while the median overall survival in the third line or later setting was 10.5 months.

    在 ESMO GI 報告的第二項研究中,RAS(ON) 抑制劑雙藥組合 daraxonrasib 加 zoldonrasib,於 RAS G12D 胰臟癌患者的二線與三線或更後線治療中展現具吸引力的初步臨床活性;其客觀反應率分別為 50% 與 47%,疾病控制率分別為 97% 與 90%,這些觀察結果與先前的臨床前研究一致。此合併療法在持久性方面的早期指標亦相當具吸引力,顯示二線與三線或更後線患者的中位無惡化存活期(PFS)分別為 9.6 個月與 7.6 個月。二線治療情境下的中位總存活期(OS)尚未達到,而三線或更後線情境下的中位總存活期為 10.5 個月。

  • The combination also showed a favorable safety and tolerability profile. Treatment-related adverse events were broadly consistent with the established profile of daraxonrasib monotherapy. These encouraging preliminary results support the planned global pivotal Phase 3 RASolute 309 study evaluating the combination of daraxonrasib plus zoldonrasib as first-line treatment in patients with RAS G12D pancreatic cancer. Our RAS(ON) inhibitors are also being evaluated in combination with other investigational approaches, including with MTA-cooperative PRMT5 inhibitors through clinical collaborations with Tango Therapeutics and Bristol Myers Squibb.

    該合併療法亦顯示良好的安全性與耐受性特徵。治療相關不良事件大致與 daraxonrasib 單藥治療的既有特徵一致。這些令人鼓舞的初步結果支持我們規劃中的全球關鍵性第三期 RASolute 309 研究,該研究評估 daraxonrasib 加 zoldonrasib 的合併療法,作為 RAS G12D 胰臟癌患者的一線治療。我們的 RAS(ON) 抑制劑亦正與其他研究性策略合併評估,包括透過與 Tango Therapeutics 及百時美施貴寶(Bristol Myers Squibb)的臨床合作,與 MTA 協同型 PRMT5 抑制劑合併。

  • I'd also like to note that RMC-5127, our RAS(ON) G12V-selective inhibitor continues in the ongoing first-in-human study. To date, RMC-5127 has been well tolerated at all dose levels evaluated with no dose-limiting toxicities reported so far. Encouraging early signs of antitumor activity have been seen across multiple tumor types, including objective responses starting at the first dose level.

    我也想補充說明,我們的 RAS(ON) G12V 選擇性抑制劑 RMC-5127 仍在進行中的首次人體試驗(first-in-human study)中持續推進。截至目前,在所有已評估的劑量水準下,RMC-5127 的耐受性良好,迄今尚未通報任何劑量限制性毒性(dose-limiting toxicities)。在多種腫瘤類型中已觀察到令人鼓舞的早期抗腫瘤活性跡象,包括自第一個劑量水準起即出現客觀反應。

  • Overall, we are increasingly confident in our ability to help redefine the standard of care for patients with pancreatic cancer across the continuum of disease from early-stage settings to advanced metastatic disease and across RAS tumor genotypes. With these opportunities comes a profound responsibility for Revolution Medicines that we take very seriously. Recognizing that every patient's disease and treatment journey is unique and treatment optionality may best serve the collective unmet needs, we remain committed to developing a broad portfolio of potential treatment options as quickly as possible. I'll now turn the call over to Alan to discuss our progress and expanding efforts in non-small cell lung cancer, along with other pipeline updates. Alan?

    整體而言,我們對於自身能力愈發有信心,能在胰臟癌患者的整個疾病歷程中——從早期情境到晚期轉移性疾病——並跨越不同 RAS 腫瘤基因型,協助重新定義照護標準。伴隨這些機會而來的是 Revolution Medicines 肩負的重大責任,我們非常嚴肅地看待。我們認知到每位患者的疾病與治療旅程皆獨一無二,而治療選項的多樣性或許最能滿足整體未被滿足的醫療需求,因此我們仍致力於以最快速度開發廣泛的潛在治療選項組合。接下來我將把電話會議交給 Alan,請他說明我們在非小細胞肺癌方面的進展與擴大中的投入,以及其他研發管線更新。Alan?

  • Alan Sandler - Chief Development Officer

    Alan Sandler - Chief Development Officer

  • Thank you, Mark. While pancreatic cancer remains an important and immediate opportunity for Revolution Medicines, non-small cell lung cancer represents another major malignancy where despite meaningful advances in treatment, significant unmet needs remain. There is growing evidence that our RAS(ON) inhibitor portfolio has the potential to significantly improve outcomes for patients with RAS-driven non-small cell lung cancer.

    謝謝你,Mark。雖然胰臟癌仍是 Revolution Medicines 重要且迫切的機會,但非小細胞肺癌則代表另一個主要惡性腫瘤領域;儘管治療已有顯著進展,仍存在大量未被滿足的需求。越來越多證據顯示,我們的 RAS(ON) 抑制劑產品組合有潛力顯著改善 RAS 驅動之非小細胞肺癌患者的治療結果。

  • We believe daraxonrasib has the potential to become an important treatment option for patients with non-small cell lung cancer. Based on encouraging previously reported non-small cell lung cancer results in patients with tumors carrying diverse RAS mutations other than RAS G12C the US FDA granted breakthrough therapy designation to daraxonrasib for previously treated metastatic non-small cell lung cancer with KRAS mutations other than G12C who have received prior platinum-based chemotherapy and anti-PD-(L)1 or PD-1 antibody therapy. Building on these encouraging Phase 1/2 results, RASolve 301, our ongoing global Phase 3 registrational study in patients with previously treated RAS-mutant non-small cell lung cancer continues to see high demand and is enrolling well. We also believe that combining targeted RAS(ON) inhibition with innovative bispecific antibodies targeting both the PD-1, PD-L1, and VEGF axes has the potential to improve outcomes for patients with previously untreated metastatic non-small cell lung cancer.

    我們相信 daraxonrasib 有潛力成為非小細胞肺癌患者的重要治療選項。基於先前已報告、在腫瘤帶有多種 RAS 突變(不含 RAS G12C)的非小細胞肺癌患者中所取得的令人鼓舞結果,美國 FDA 已授予 daraxonrasib「突破性療法認定」(breakthrough therapy designation),適用於既往治療之轉移性非小細胞肺癌患者,其 KRAS 突變為 G12C 以外,且已接受含鉑化療與抗 PD-(L)1 或 PD-1 抗體治療。在這些令人鼓舞的第一/二期結果基礎上,我們正在進行的全球第三期註冊性研究 RASolve 301(針對既往治療之 RAS 突變非小細胞肺癌患者)持續需求旺盛,且收案進展良好。我們也相信,將標靶 RAS(ON) 抑制與創新的雙特異性抗體(同時鎖定 PD-1、PD-L1 與 VEGF 軸)結合,有潛力改善既往未治療之轉移性非小細胞肺癌患者的治療結果。

  • In particular, through our ongoing clinical collaboration with Summit Therapeutics, we are evaluating daraxonrasib in combination with ivonescimab, Summit's PD-1 VEGF bispecific antibody and platinum doublet therapy in first-line non-small cell lung cancer. With impactful targeted therapies available now for patients with non-small cell lung cancer with tumors harboring EGFR, ALK, ROS1, RET, KRAS G12C or other genetic alterations, we recognize that practitioners increasingly view treatment of lung cancer through a biomarker-directed lens. In the context of RAS-driven disease, significant unmet needs remain across patients with non-small cell lung cancer carrying diverse RAS mutations for which no approved targeted therapies have been approved. Revolution Medicines is uniquely positioned to address these needs through our broad and differentiated pipeline of targeted inhibitors.

    特別是透過我們與 Summit Therapeutics 持續進行的臨床合作,我們正在評估 daraxonrasib 與 ivonescimab(Summit 的 PD-1/VEGF 雙特異性抗體)及含鉑雙藥治療(platinum doublet therapy)合併,用於非小細胞肺癌一線治療。目前針對腫瘤帶有 EGFR、ALK、ROS1、RET、KRAS G12C 或其他基因變異的非小細胞肺癌患者,已存在具影響力的標靶治療可用;因此我們理解臨床醫師愈來愈以生物標記導向(biomarker-directed)的視角來看待肺癌治療。在 RAS 驅動疾病的情境下,對於帶有多樣 RAS 突變且尚無核准標靶治療的非小細胞肺癌患者,仍存在顯著未被滿足的需求。Revolution Medicines 憑藉我們廣泛且具差異化的標靶抑制劑研發管線,具備獨特優勢來滿足這些需求。

  • Approximately 30% of patients with non-small cell lung cancer have tumors harboring a RAS mutation and our RAS(ON) mutant selective inhibitors, elironrasib, zoldonrasib and RMC-5127 targeting RAS G12C, G12D and G12V, respectively, have the potential to address over 70% of RAS-driven mutations in this disease. In the first-line setting, we're actively evaluating elironrasib and zoldonrasib in combination with the current standard of care regimen of pembrolizumab plus platinum doublet chemotherapy. We previously reported Phase 1 data for zoldonrasib and elironrasib monotherapy in previously treated RAS G12D or G12C non-small cell lung cancer, respectively, each exhibiting highly encouraging monotherapy efficacy and safety profiles.

    約有 30% 的非小細胞肺癌患者其腫瘤帶有 RAS 突變;而我們的 RAS(ON) 突變選擇性抑制劑 elironrasib、zoldonrasib 與 RMC-5127 分別鎖定 RAS G12C、G12D 與 G12V,具備涵蓋此疾病中超過 70% RAS 驅動突變的潛力。在一線治療情境中,我們正積極評估 elironrasib 與 zoldonrasib,與目前標準治療方案 pembrolizumab 加含鉑雙藥化療合併使用。我們先前已報告 zoldonrasib 與 elironrasib 單藥治療的第一期數據,分別用於既往治療之 RAS G12D 或 RAS G12C 非小細胞肺癌患者;兩者皆展現高度令人鼓舞的單藥療效與安全性特徵。

  • Today, I'm pleased to share new observations for each of these compounds in combination with pembrolizumab and chemotherapy in patients with previously untreated non-small cell lung cancer, data which we believe demonstrate the differentiated and compelling potential of our RAS(ON) mutant selective inhibitors in this treatment context. I'll begin with zoldonrasib, our RAS(ON) G12D selective inhibitor. The baseline characteristics of patients enrolled in this cohort are representative of the KEYNOTE-189 study population, which evaluated pembrolizumab plus platinum doublet chemotherapy. The principal difference is a somewhat lower proportion of patients with high PD-L1 expression, while other key demographic and disease characteristics are broadly consistent with expectations for patients with previously untreated metastatic non-small cell lung cancer. Taken together, these baseline characteristics provide an appropriate context for interpreting the safety and efficacy observations I'll discuss next.

    今天,我很高興分享這兩項化合物各自在既往未治療之非小細胞肺癌患者中,與 pembrolizumab 及化療合併使用的新觀察結果;我們相信這些數據展現了我們 RAS(ON) 突變選擇性抑制劑在此治療情境下具差異化且引人注目的潛力。我將先從 zoldonrasib(我們的 RAS(ON) G12D 選擇性抑制劑)談起。納入此隊列患者的基線特徵,具代表性地反映了 KEYNOTE-189 研究族群;該研究評估 pembrolizumab 加含鉑雙藥化療。主要差異在於高 PD-L1 表現患者的比例略低,而其他關鍵人口學與疾病特徵大致符合對既往未治療之轉移性非小細胞肺癌患者的預期。綜合而言,這些基線特徵為解讀我接下來將討論的安全性與療效觀察結果提供了適切的背景。

  • The safety profile of zoldonrasib was highly encouraging. Treatment-related adverse events were again broadly consistent with the established profile of pembrolizumab plus chemotherapy with no new or unexpected safety signals observed. With the data cutoff of May 11, 2026, the majority of adverse events were grade 1 or grade 2. No grade 5 treatment-related adverse events were reported, and there was a low incidence of liver enzyme elevations, which were manageable with standard dose modifications.

    zoldonrasib 的安全性概況極具鼓舞性。與治療相關的不良事件再次大致與已建立的 pembrolizumab 合併化療之概況一致,未觀察到新的或非預期的安全性訊號。截至 2026 年 5 月 11 日的資料截止日,多數不良事件為第 1 級或第 2 級。未通報第 5 級與治療相關的不良事件,且肝酵素升高的發生率偏低,並可透過標準劑量調整加以處理。

  • The combination of zoldonrasib with pembrolizumab and platinum-based chemotherapy demonstrated encouraging antitumor activity in patients with previously untreated KRAS G12D non-small cell lung cancer. With the data cutoff of May 11, 2026, and median follow-up of 3.4 months, the objective response rate was 82%, with disease control achieved in all evaluable patients. Importantly, responses were observed across PD-L1 expression subgroups, including patients with low PD-L1 expression, supporting the broad activity of this combination. And although follow-up remains early, these findings provide encouraging evidence supporting this differentiated treatment strategy. Overall, these findings support the continued development of zoldonrasib in combination with standard of care.

    zoldonrasib 與 pembrolizumab 及鉑類為基礎的化療之合併治療,在先前未治療的 KRAS G12D 非小細胞肺癌患者中展現出令人鼓舞的抗腫瘤活性。截至 2026 年 5 月 11 日的資料截止日,且中位隨訪 3.4 個月,客觀緩解率為 82%,且所有可評估患者皆達到疾病控制。重要的是,在各 PD-L1 表現量亞組中皆觀察到反應,包括 PD-L1 低表現患者,支持此合併療法具廣泛活性。儘管隨訪仍屬早期,這些結果仍提供了支持此差異化治療策略的令人鼓舞證據。整體而言,這些發現支持持續推進 zoldonrasib 與標準治療合併的開發。

  • Turning now to elironrasib, our RAS(ON) G12C selective inhibitor. As with the zoldonrasib cohort, the baseline characteristics of patients enrolled in this study are generally representative of the population treated in pembrolizumab plus platinum doublet chemotherapy. The primary difference being a somewhat lower proportion of patients with PD-L1 negative subgroup and a higher proportion of patients with PD-L1 expression in the 1% to 49% subgroup. Overall, these baseline characteristics establish an appropriate context for interpreting the efficacy and safety observations I'll review next.

    接下來談 elironrasib,我們的 RAS(ON) G12C 選擇性抑制劑。與 zoldonrasib 隊列相同,本研究納入患者的基線特徵整體上可代表接受 pembrolizumab 合併鉑類雙藥化療治療的人群。主要差異在於 PD-L1 陰性亞組患者比例略低,而 PD-L1 表現量介於 1% 至 49% 亞組的患者比例較高。整體而言,這些基線特徵為解讀我接下來將回顧的療效與安全性觀察結果提供了適切的背景。

  • Elironrasib continues to demonstrate a manageable safety and tolerability profile in combination with pembrolizumab and chemotherapy. Treatment-related adverse events were consistent with the established safety profile of pembrolizumab-based chemotherapy with minimal evidence of additive toxicity attributable to elironrasib. We were particularly encouraged by the favorable liver safety profile with relatively few grade 3 or higher transaminase elevations and no unexpected safety findings.

    elironrasib 與 pembrolizumab 及化療合併使用時,持續展現出可管理的安全性與耐受性概況。與治療相關的不良事件與已建立的以 pembrolizumab 為基礎之化療安全性概況一致,幾乎沒有證據顯示 elironrasib 帶來額外的累加毒性。我們尤其對良好的肝臟安全性概況感到鼓舞,轉胺酶升高達第 3 級或以上者相對較少,且未見非預期的安全性發現。

  • Turning now to efficacy of elironrasib in combination with pembrolizumab and chemotherapy. Similar to what we observed with zoldonrasib, we have observed highly encouraging antitumor activity with elironrasib in combination with pembrolizumab and platinum-based chemotherapy in patients with previously untreated RAS G12C non-small cell lung cancer. Across the treated population with the data cutoff of May 11, 2026, and 8.7 months of median follow-up, the confirmed objective response rate was 85% with a disease control rate of 97%. Responses were observed across PD-L1 expression subgroups and like zoldonrasib, the elironrasib combination regimen appears to be highly competitive with the current standard of care of KEYNOTE-189 regimen. The early observations of durability were also encouraging with a progression-free survival rate at six months of 95%.

    接下來談 elironrasib 與 pembrolizumab 及化療合併的療效。與我們在 zoldonrasib 所觀察到的情況類似,在先前未治療的 RAS G12C 非小細胞肺癌患者中,elironrasib 合併 pembrolizumab 與鉑類為基礎的化療亦展現出極具鼓舞的抗腫瘤活性。在截至 2026 年 5 月 11 日的資料截止日、且中位隨訪 8.7 個月的已治療人群中,經確認的客觀緩解率為 85%,疾病控制率為 97%。在各 PD-L1 表現量亞組中皆觀察到反應;且如同 zoldonrasib,elironrasib 的合併療程看起來在競爭力上可與目前標準治療 KEYNOTE-189 療程相匹敵。對持久性的早期觀察亦令人鼓舞,6 個月無惡化存活率為 95%。

  • We believe these early findings suggest that the responses observed are not only frequent, but also have the potential to be durable. We believe these results reinforce the significant potential for targeted RAS(ON) inhibition to further improve outcomes when combined with current standard of care.

    我們認為這些早期發現顯示,所觀察到的反應不僅發生頻率高,亦具有持久的潛力。我們相信,這些結果強化了標靶 RAS(ON) 抑制在與現行標準治療合併時,進一步改善治療結果的重大潛力。

  • Taken together, we believe these observations support continued development of elironrasib in combination with standard of care pembrolizumab and platinum-based chemotherapy. As a whole, and consistent with the impact seen in pancreatic cancer, these emerging data showing a well-tolerated and highly encouraging antitumor profile provide evidence that our RAS(ON) mutant-selective inhibitors have the potential to become important first-line treatment options for patients with metastatic non-small cell lung cancer.

    綜合而言,我們認為這些觀察結果支持持續推進 elironrasib 與標準治療 pembrolizumab 及鉑類為基礎的化療之合併開發。整體來看,且與在胰臟癌中所見的影響一致,這些新興數據顯示其耐受性良好且抗腫瘤概況極具鼓舞性,提供證據顯示我們的 RAS(ON) 突變選擇性抑制劑有潛力成為轉移性非小細胞肺癌患者的重要第一線治療選項。

  • We are observing that practitioners increasingly view treatment of lung cancer through a biomarker-directed lens and recognize the significant unmet needs that remain across patients with RAS mutant non-small cell lung cancer. With our broad and differentiated portfolio of RAS(ON) mutant selective inhibitors, we believe we are uniquely positioned to address these needs. Accordingly, in the next stage of our approach in non-small cell lung cancer, we are advancing both zoldonrasib and elironrasib into registrational development in combination with standard of care in first-line non-small cell lung cancer with the goal of addressing the majority of patients with RAS-mutant disease. We recently initiated RASolve 308, a randomized placebo-controlled trial evaluating zoldonrasib with pembrolizumab plus doublet platinum chemotherapy in patients with RAS G12D non-small cell lung cancer. And we expect to initiate RASolve 307, a randomized placebo-controlled trial evaluating elironrasib with pembrolizumab plus doublet platinum chemotherapy in patients with RAS G12C non-small cell lung cancer.

    我們觀察到臨床醫師日益以生物標記導向的視角看待肺癌治療,並認知到 RAS 突變非小細胞肺癌患者仍存在顯著未被滿足的需求。憑藉我們廣泛且具差異化的 RAS(ON) 突變選擇性抑制劑產品組合,我們相信自身具備獨特優勢以回應這些需求。因此,在我們針對非小細胞肺癌的下一階段策略中,我們正推進 zoldonrasib 與 elironrasib 進入註冊性開發,並在第一線非小細胞肺癌中與標準治療合併,目標是涵蓋多數 RAS 突變疾病患者。我們近期啟動 RASolve 308,這是一項隨機、安慰劑對照試驗,評估 zoldonrasib 合併 pembrolizumab 及鉑類雙藥化療,用於 RAS G12D 非小細胞肺癌患者。我們亦預期將啟動 RASolve 307,這是一項隨機、安慰劑對照試驗,評估 elironrasib 合併 pembrolizumab 及鉑類雙藥化療,用於 RAS G12C 非小細胞肺癌患者。

  • Further, with the encouraging initial observations mentioned earlier for RMC-5127 in patients with tumors harboring a G12V mutation, we anticipate studying RMC-5127 in the first-line non-small cell lung cancer setting as well.

    此外,基於先前提及 RMC-5127 在腫瘤帶有 G12V 突變患者中的令人鼓舞之初步觀察,我們也預期將在第一線非小細胞肺癌情境中研究 RMC-5127。

  • While we conduct registrational studies for mutant selective inhibitors, we are also evaluating a broader set of first-line treatment strategies, including our multi-selective inhibitor daraxonrasib as well as our mutant selective inhibitors in combinations with emerging bispecific antibodies and chemotherapy. The additional information and insights we gain over time will inform decisions about potential future registrational plans. This layered portfolio strategy reflects our deep commitment to developing multiple targeted treatments across the spectrum of RAS mutant non-small cell lung cancer. As we have done in pancreatic cancer, we are advancing multiple potential solutions on behalf of patients with the goal of providing multiple first-line treatment options for patients with RAS mutant non-small cell lung cancer.

    在我們為突變選擇性抑制劑進行註冊性研究的同時,我們也在評估更廣泛的第一線治療策略,包括我們的多重選擇性抑制劑 daraxonrasib,以及我們的突變選擇性抑制劑與新興雙特異性抗體及化療的合併方案。我們隨時間取得的額外資訊與洞見,將為未來可能的註冊性計畫決策提供依據。此分層式產品組合策略反映了我們對於在 RAS 突變非小細胞肺癌全譜中開發多種標靶治療的深度承諾。如同我們在胰臟癌所做的,我們正代表患者推進多項潛在解決方案,目標是為 RAS 突變非小細胞肺癌患者提供多種第一線治療選項。

  • I'll now hand the call over to Jack.

    我現在把電話交給 Jack。

  • Jack Anders - Chief Financial Officer

    Jack Anders - Chief Financial Officer

  • Thanks, Alan. Our financial position remains exceptionally strong and continues to provide the flexibility needed to support the rapid advancement of our portfolio and our commercial preparations. We ended the second quarter of 2026 with $3.9 billion in cash and investments. This balance includes the proceeds from our concurrent public offerings of common stock and convertible notes in April of this year, resulting in $2.2 billion in gross proceeds before deducting underwriting discounts, commissions and offering expenses. The ending second quarter balance also includes the receipt of the second royalty tranche of $250 million from our funding arrangement with Royalty Pharma.

    謝謝,Alan。我們的財務狀況仍然格外強健,並持續提供所需的彈性,以支持我們產品組合的快速推進以及商業化準備。我們在 2026 年第二季結束時,現金與投資為 39 億美元。此餘額包含我們於今年 4 月同步進行普通股公開發行與可轉換公司債發行的募集款項,扣除承銷折扣、佣金及發行費用前,總募集金額為 22 億美元。第二季期末餘額亦包含我們與 Royalty Pharma 的資金安排所收到的第二筆權利金分期款 2.5 億美元。

  • There remains up to an additional $1.5 billion in committed flexible capital under this funding arrangement, subject to the achievement of specific milestones. Moving to expenses. R&D expenses for the second quarter of 2026 were $395 million compared to $224 million for the second quarter of 2025. The increase in 2026 was primarily due to increased clinical trial and manufacturing expenses for daraxonrasib and zoldonrasib, increased personnel-related costs due to additional headcount and higher stock-based compensation expense related to increased headcount and changes in retirement provisions in 2026 previously described on our Q1 2026 earnings call. G&A expenses for the second quarter of 2026 were $110 million compared to $41 million for the second quarter of 2025.

    在此資金安排下,仍有最高額外 15 億美元的已承諾彈性資金可供動用,但須達成特定里程碑。接著談費用。2026 年第二季研發(R&D)費用為 3.95 億美元,較 2025 年第二季的 2.24 億美元增加。2026 年的增加主要由於 daraxonrasib 與 zoldonrasib 的臨床試驗與製造費用上升、因新增人力而增加的人員相關成本,以及與新增人力及 2026 年退休制度條款變更相關、且我們先前已在 2026 年第一季財報電話會議中說明的較高股權基礎薪酬費用。2026 年第二季一般及行政(G&A)費用為 1.10 億美元,較 2025 年第二季的 4,100 萬美元增加。

  • The increase in G&A expenses in 2026 was primarily due to higher personnel-related costs associated with higher -- with additional headcount, higher stock-based compensation expense related to increased headcount and changes in retirement provisions in 2026, increased commercialization preparation activities, and higher administrative costs.

    2026 年 G&A(一般及行政)費用的增加,主要是由於與人員相關成本上升所致,這與人力編制增加、因人力增加而提高的以股份為基礎之薪酬費用,以及 2026 年退休金提撥規定的變動有關;同時也包括商業化準備活動增加,以及較高的行政成本。

  • Net loss for the second quarter of 2026 was $644 million compared to $248 million for the second quarter of 2025. Net loss for the quarter ended June 30, 2026, included a noncash charge of $151 million related to a change in the fair value of warrants we assumed as part of the company's acquisition of EQRx. This change in the fair value of warrants is due to the increase in our stock price. The additional increase in net loss in 2026 was due to higher operating expenses. Turning to financial guidance.

    2026 年第二季淨損為 6.44 億美元,較 2025 年第二季的 2.48 億美元增加。截至 2026 年 6 月 30 日止季度的淨損,包含一筆 1.51 億美元的非現金費用,係與我們在公司收購 EQRx 時承接之認股權證公允價值變動相關。該認股權證公允價值的變動,係由於我們股價上升所致。2026 年淨損進一步增加,係因營運費用較高。接下來談財務指引。

  • The company is updating its projected 2026 GAAP operating expense expectations and now expects full year 2026 GAAP operating expenses to be between $2.1 billion and $2.2 billion. This includes expected noncash stock-based compensation expense of between $270 million and $290 million. Today's updated guidance reflects our growing confidence in the breadth of our clinical pipeline and the magnitude of the opportunities ahead.

    公司正在更新其 2026 年 GAAP 營運費用預期,現預估 2026 全年 GAAP 營運費用將介於 21 億至 22 億美元之間。其中包含預期的非現金以股份為基礎之薪酬費用,約 2.70 億至 2.90 億美元。今日更新後的指引,反映我們對臨床產品線廣度以及未來機會規模的信心持續提升。

  • As a result, we plan to increase our investment and spend in 2026, driven largely by three main factors: First, we are accelerating and increasing manufacturing for both commercial and clinical supply of daraxonrasib and zoldonrasib to ensure we have sufficient supply to meet a range of potential demand scenarios. Second, we anticipate higher clinical development expenses as we continue to execute on our aggressive development strategy across multiple programs within our portfolio with increased confidence. And third, we are accelerating and increasing investments in our commercial readiness efforts to support our preparedness for potential US launches while also expanding our international infrastructure to support potential future launches outside the US. These additional investments in 2026 position us to execute on our bold ambitions for our portfolio.

    因此,我們計畫在 2026 年提高投資與支出,主要由三項因素驅動:第一,我們正加速並提高 daraxonrasib 與 zoldonrasib 的商業與臨床供應製造,以確保在各種潛在需求情境下都有充足供應。第二,隨著我們更有信心地在產品組合內多個計畫上執行積極的開發策略,我們預期臨床開發費用將上升。第三,我們正加速並增加對商業化就緒(commercial readiness)工作的投資,以支援我們為潛在美國上市所做的準備,同時也擴充國際基礎建設,以支援未來在美國以外地區的潛在上市。這些 2026 年的額外投資,使我們得以推進並實現我們對產品組合的宏大目標。

  • That concludes the financial update. I'll now turn the call back over to Mark.

    以上為財務更新。我現在把電話交回給 Mark。

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Jack. Before we open the call for questions, I'd like to briefly highlight our key upcoming priorities. Overall, we've begun the second half of 2026 with strong momentum and a compelling set of priorities. In pancreatic cancer, following the unprecedented results from RASolute 302, the US FDA has accepted our full NDA submission for review.

    謝謝你,Jack。在我們開放提問之前,我想簡要強調接下來幾項重要優先事項。整體而言,我們以強勁動能與一系列具吸引力的優先事項展開 2026 年下半年。在胰臟癌方面,繼 RASolute 302 取得前所未有的結果後,美國 FDA 已受理我們完整的 NDA 申請並進入審查。

  • The EMA has initiated its phase review of daraxonrasib, and we are well prepared to execute a successful launch, subject to regulatory approvals. In addition, the global RASolute 303, 304 and 305 studies are actively enrolling, and we have initiated RASolute 309. In lung cancer, we expect to complete enrollment in RASolve 301 this year, supporting an initial readout in 2027. We also continue following patients in the zoldonrasib monotherapy expansion cohort in previously treated RAS G12D non-small cell lung cancer and have initiated RASolve 308, evaluating zoldonrasib in combination with standard of care in first-line RAS G12D non-small cell lung cancer. We are also preparing to initiate RASolve 307, evaluating elironrasib in combination with standard of care in first-line RAS G12C non-small cell lung cancer in the fourth quarter of 2026.

    EMA 已啟動對 daraxonrasib 的分階段審查(phase review),在取得監管核准的前提下,我們已充分準備好成功上市。此外,全球 RASolute 303、304 與 305 研究正積極收案,我們也已啟動 RASolute 309。在肺癌方面,我們預期今年完成 RASolve 301 的收案,以支持於 2027 年進行初步數據揭露。我們也持續追蹤先前治療過之 RAS G12D 非小細胞肺癌患者在 zoldonrasib 單藥擴增隊列中的表現,並已啟動 RASolve 308,評估 zoldonrasib 與一線 RAS G12D 非小細胞肺癌標準治療的合併使用。我們也正準備在 2026 年第四季啟動 RASolve 307,評估 elironrasib 與一線 RAS G12C 非小細胞肺癌標準治療的合併使用。

  • In colorectal cancer, we look forward to providing a data update and visibility into our development plans during the fourth quarter of this year.

    在大腸直腸癌方面,我們期待在今年第四季提供數據更新,並讓各界更清楚了解我們的開發計畫。

  • With our earlier-stage pipeline, we expect to identify the recommended Phase 2 dose for RMC-5127 in the second half of this year and share initial clinical data in 2027. We also remain on track to initiate the first-in-human study of RM-055, our first inhibitor from our innovative new class of mutant targeted catalytic RAS(ON) inhibitors in the fourth quarter. Taken together, these milestones reflect the breadth, pace and ambition of Revolution Medicines today. We are preparing for a potential first commercial launch, conducting multiple registration programs and leading with further RAS innovation, all with intensity and continued excellence in execution. The progress we've made is the result of years of growing scientific conviction, disciplined investment and relentless effort by our team and collaborators.

    就我們較早期的產品線而言,我們預期在今年下半年確定 RMC-5127 的第二期建議劑量,並於 2027 年分享初步臨床數據。我們也仍按計畫在第四季啟動 RM-055 的首次人體試驗;RM-055 是我們創新新類別「突變靶向催化型 RAS(ON) 抑制劑」中的首個抑制劑。綜合而言,這些里程碑反映了 Revolution Medicines 目前的廣度、速度與企圖心。我們正為潛在的首次商業化上市做準備,同時推進多項註冊性研究計畫,並以更進一步的 RAS 創新領先前行;我們以高度投入並持續卓越的執行力來推動這一切。我們所取得的進展,是多年來科學信念日益堅定、紀律性投資,以及我們團隊與合作夥伴不懈努力的成果。

  • We believe we are now in a strong position to redefine what is possible for patients with RAS-driven cancers, beginning with pancreatic cancer and lung cancer and colorectal cancer coming soon as well. With our differentiated know-how, organizational depth and financial strength, we intend to continue operating against our aggressive plan with the urgency patients deserve.

    我們相信,我們如今已處於有利位置,能重新定義 RAS 驅動型癌症患者的治療可能性,並將從胰臟癌與肺癌開始,且大腸直腸癌也將很快跟進。憑藉我們差異化的專業能力、組織深度與財務實力,我們打算以患者所應得的緊迫感,持續依照我們積極的計畫推進營運。

  • I'd like to thank patients and their families, our investigators and healthcare partners, our employees and our shareholders for their continued support and confidence. The ongoing support of all of our partners and constituencies is needed to deliver revolutionary advances on behalf of patients.

    我要感謝患者及其家屬、我們的研究者與醫療照護合作夥伴、員工以及股東,持續給予支持與信任。我們所有合作夥伴與利害關係人的持續支持,對於代表患者實現革命性進展至關重要。

  • With that, I'll turn the call over to the operator for the Q&A portion of the call.

    接下來,我把電話交給接線員,進入問答環節。

  • Operator

    Operator

  • (Operator Instructions) Marc Frahm, TD Cowen.

    (接線員指示)TD Cowen 的 Marc Frahm。

  • Marc Frahm - Analyst

    Marc Frahm - Analyst

  • Congrats on the progress you've made so far. Maybe on CRC, we're going to be getting that. Just what's your latest thoughts on kind of what proof-of-concept looks like in that indication, particularly after we've seen adagrasib's confirmatory trial in the second-line setting kind of failed to demonstrate PFS or OS benefit despite what appeared to be pretty exciting response rate data? And then just on the lung cancer side, can you maybe just walk through the confidence that on the G12C, not just that you can beat current standard of care, but there's also second-line trials or second-gen G12C trials running right now in the first line. Why do you think you're going to be better than those that will presumably have data faster than your trials?

    恭喜你們目前取得的進展。或許先談 CRC(大腸直腸癌),我們將會拿到那個(更新)。想請教你們對於該適應症中「概念驗證」(proof-of-concept)應該呈現什麼樣貌的最新看法,特別是在我們看到 adagrasib 於二線治療的確認性試驗中,儘管反應率數據看起來相當令人振奮,但卻未能證明 PFS 或 OS 的獲益之後?另外在肺癌方面,你能否談談你們對 G12C 的信心:不只是能優於目前標準治療,而且目前也有二線試驗或第二代 G12C 試驗正在一線進行。你們為何認為自己會優於那些可能比你們試驗更快產出數據的方案?

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Marc, thanks for your questions. On the CRC question, I think that's best addressed when we are able to frame our plans and provide some data. So I'm just going to ask that we defer that to a later time when I can be more concrete.

    Marc,謝謝你的提問。關於 CRC 的問題,我認為最好等到我們能夠說明我們的計畫並提供一些數據時再回答。所以我想請你允許我們先暫緩,等到之後我能更具體時再談。

  • On the non-small cell lung cancer question with regard to elironrasib, maybe Alan Sandler can make a comment on that.

    至於 elironrasib 在非小細胞肺癌方面的問題,也許可以請 Alan Sandler 回應。

  • Alan Sandler - Chief Development Officer

    Alan Sandler - Chief Development Officer

  • Sure. Thanks, and thanks for the question. So an important question. We believe that elironrasib has a very good profile, both safety and efficacy. And we're always data-driven in terms of our decision-making.

    好的。謝謝,也謝謝你的問題。這確實是個重要問題。我們相信 elironrasib 具備非常好的特性,包括安全性與療效。而且我們在決策上始終以數據為依據。

  • And we felt that it was important to have a robust data set available in order to make this important decision.

    我們認為,為了做出這項重要決策,必須具備一套扎實且充分的數據集。

  • Given that and given the data that we've shown you today, we believe that elironrasib has a highly competitive profile, both again, in monotherapy, potentially in subsequent lines of therapy and also in that first-line line of therapy in combination with pembrolizumab and doublet chemotherapy.

    基於這點,以及我們今天向各位展示的數據,我們相信 elironrasib 具有高度競爭力的特性:同樣地,無論是單藥治療、可能用於後續治療線別,或是在一線治療中與 pembrolizumab 及雙藥化療合併使用。

  • And in addition, what I would add is with our suite of mutant selective agents, we have a very compelling position in that setting as we will be able to target over 70% of the patients with RAS mutant non-small cell lung cancer.

    此外,我還要補充的是,憑藉我們一系列突變選擇性藥物,我們在該治療情境中具備非常有利的定位,因為我們將能鎖定超過 70% 的 RAS 突變非小細胞肺癌患者。

  • Operator

    Operator

  • Charles Zhu, LifeSci Capital.

    Charles Zhu,LifeSci Capital。

  • Charles Zhu - Equity Analyst

    Charles Zhu - Equity Analyst

  • Congrats on all the broad progress across the board. Maybe one for me regarding frontline non-small cell lung cancer. So great to see either current or ongoing plans with various mutant selective inhibitors in combination with standard of care. I think you had also mentioned evaluating further opportunities not only with novel bispecifics, which makes sense, but also with the multi-selective RAS inhibitors. Curious as to your thoughts around given the multiple mutant selective you have covering a lot of those patients, how might you position a RAS multi-selective in that frontline setting?

    恭喜你們在各方面都取得了廣泛進展。我這邊可能有一題,關於一線非小細胞肺癌。很高興看到你們目前或正在規劃,將各種突變選擇性抑制劑與標準治療合併使用。我想你們也提到,除了新型雙特異性抗體(這很合理)之外,也在評估多選擇性 RAS 抑制劑的進一步機會。想請教你們的看法:在你們已經有多個突變選擇性藥物、可涵蓋許多患者的情況下,你們會如何在一線治療情境中定位 RAS 多選擇性藥物?

  • And would -- did that terminology refer to daraxonrasib or possibly RM-055 as well?

    另外,你剛才提到的那個用語——是指 daraxonrasib,還是也包含 RM-055?

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Yes. Thank you, Charles. Appreciate the question. I think all possibilities are still on the table. We've intentionally pursued both the multi-selective as well as the mutant selective inhibitors to create the most optionality for us and then ultimately for patients.

    是的。謝謝你,Charles。感謝這個問題。我認為所有可能性目前都仍在考量之中。我們刻意同時推進多選擇性以及突變選擇性抑制劑,為我們、也最終為患者創造最大的選擇彈性。

  • And I think all of this will play out over time. We still think it's premature to make any exclusive commitments down to any particular treatment regimen. And as long as there remains the possibility that more than one regimen might be complementary and provide options for various patients, we'll pursue them. So this will continue to play out. You're now seeing us moving pretty aggressively with two mutant selective inhibitors and the third to come behind it.

    我想這一切會隨時間逐步明朗。我們仍認為,現在就對任何特定治療方案做出排他性的承諾還為時過早。只要仍有可能存在不只一種方案彼此互補、並為不同患者提供選項,我們就會持續推進。因此這會繼續發展。你們現在看到我們正相當積極地推進兩個突變選擇性抑制劑,第三個也將緊接其後。

  • But by no means are we deprioritizing either daraxonrasib or RM-055 that's coming up or things that might come behind that as well.

    但我們絕對沒有降低 daraxonrasib 或即將推出的 RM-055 的優先順序,或是後續可能跟進的其他項目。

  • Operator

    Operator

  • Michael Schmidt, Guggenheim.

    Michael Schmidt,Guggenheim。

  • Michael Schmidt - Analyst

    Michael Schmidt - Analyst

  • Congrats on all the progress and news today. I had a question on daraxonrasib. And I'm just curious if you have any early feedback from the EAP program and how the products perhaps are performing relative to the clinical trial experience?

    恭喜今天所有的進展與消息。我有一題關於 daraxonrasib。我想請教你們是否從 EAP 計畫中收到任何早期回饋,以及這些產品的表現相較於臨床試驗經驗如何?

  • And secondly, what could the regulatory timelines in Europe look like based on this Phase 1 review process that's underway there?

    第二題,基於目前在歐洲進行中的第一期審查流程,歐洲的法規時程可能會是什麼樣子?

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Michael. The EAP is quite robust now. We're serving a lot of patients. We don't have a mechanism to get explicit or quantitative feedback from those who are prescribing it since that -- this is a clinical access program. It's not a clinical trial.

    謝謝你,Michael。EAP 現在相當健全。我們正在服務很多患者。由於這是一個臨床用藥可近性計畫,而不是臨床試驗,因此我們沒有機制從開立處方者那裡取得明確或量化的回饋。

  • So we really don't have quantitative information. And I'm not sure that we ultimately ever will.

    所以我們確實沒有量化資訊。而且我也不確定我們最終是否會有。

  • Sort of on a qualitative basis, we certainly have feedback from some institutions that they're very enthusiastic. Some of the larger institutions have enrolled quite large numbers of patients, and they're continuing to enroll new patients. So that suggests that their experience so far is encouraging. We also do get anecdotal information from patients or their families, but that doesn't add up to a fair and broad-based representation. But from that anecdotal evidence, patients and their families are quite encouraged by having received access.

    就質性層面而言,我們確實從一些機構收到回饋,表示他們非常熱衷。一些較大型的機構已納入相當多的患者,且仍持續納入新患者。這顯示他們目前的使用經驗是令人鼓舞的。我們也會從患者或其家屬那裡得到一些軼聞資訊,但這不足以構成公平且具廣泛代表性的樣本。不過從這些軼聞證據來看,患者及其家屬對於能獲得用藥機會感到相當振奮。

  • So that's pretty much what we know from the EAP now, and I'm sure will continue to grow.

    所以這大致就是我們目前從 EAP 所了解的情況,而且我相信這些資訊也會持續累積。

  • With regard to the regulatory timelines in Europe, there's really not much we can provide on that. The EMA made it clear that the phase review is intended to be an expedited review process. What that actually ends up meaning really is a question for the EMA, and we'll just support it as well as we can.

    至於歐洲的法規時程,我們其實沒有太多可以提供的。EMA 已明確表示,分期審查(phase review)旨在成為加速審查流程。但這最終實際代表什麼,確實要由 EMA 來決定;我們只能盡力配合與支持。

  • Operator

    Operator

  • Cory Kasimov, Evercore ISI.

    Cory Kasimov,Evercore ISI。

  • Cory Kasimov - Analyst

    Cory Kasimov - Analyst

  • So I want to ask about your Phase 3 frontline PDAC studies. For patients that end up in the control arm, how do you plan to assess those that drop out potentially even after receiving just a single dose of chemo and then eventually go on to receive commercial daraxonrasib upon approval? How much of a risk might this dynamic pose to your frontline studies in terms of measuring OS and potentially even PFS?

    我想問你們的第三期一線 PDAC 研究。對於最後被分配到對照組的患者,你們打算如何評估那些可能在只接受一劑化療後就退出、並在 daraxonrasib 獲批後最終轉而使用商業供應 daraxonrasib 的患者?這種動態對你們的一線研究在衡量 OS、甚至可能 PFS 方面,會帶來多大的風險?

  • And then a follow-up, just a clarification question. With the EAP, did those patients convert to commercial patients upon approval of daraxonrasib?

    另外一個追問,算是釐清:在 EAP 中的那些患者,在 daraxonrasib 獲批後是否會轉為商業用藥患者?

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Cory. I appreciate your questions. The first question is about first-line PDAC in the Phase 3 trial, I think you're really raising the question of crossover, some form of crossover risk for patients moving on to daraxonrasib.

    謝謝你,Cory。感謝你的提問。第一題是關於第三期試驗中一線 PDAC,我想你真正提出的是交叉用藥(crossover)——也就是患者轉用 daraxonrasib 的某種交叉風險。

  • Maybe Wei Lin, our Chief Medical Officer, can comment on that, and then I'll come back to the EAP.

    也許我們的首席醫學官 Wei Lin 可以先回應這點,之後我再回到 EAP 的問題。

  • Wei Lin - Chief Medical Officer

    Wei Lin - Chief Medical Officer

  • Yes. Thanks, Mark. Thanks for the question. Yes. It is certainly a very important question that we have given a lot of thought and planning to because we want to ensure the success of the 303 trial in frontline PDAC while we're trying to making sure patients globally have access to daraxonrasib in the future

    好的。謝謝,Mark。謝謝這個問題。是的。這確實是一個非常重要的問題,我們已投入大量思考與規劃,因為我們希望在推動一線 PDAC 的 303 試驗成功的同時,也確保未來全球患者能取得 daraxonrasib 的用藥機會。

  • I think the -- currently, the Phase 3 trial has a co-primary endpoint of PFS and overall survival. And then it's -- the dropout in control would not affect the PFS obviously, but it could potentially affect the overall survival analysis. And so right now, we're trying to be very thoughtful in geographically the sites that we're activating 303 trial in, knowing that the global approval as well as access will be graduated starting with the US and the rest of the world in a gradual fashion. So that's certainly, I think, one area.

    我想目前第三期試驗有兩個共同主要終點(co-primary endpoint):PFS 與總生存期(overall survival)。對照組的退出顯然不會影響 PFS,但可能會影響總生存期的分析。因此目前我們在啟動 303 試驗的地理佈點上非常審慎,因為我們知道全球核准與可近性將是分階段推進,先從美國開始,之後再逐步擴及世界其他地區。我認為這是其中一個面向。

  • And the other is really working with investigators to making sure that the patients really understand their options before they come on trials and then probably be conducted in a rigorous fashion so then the integrity of the center experiment is maintained.

    另一個面向是與研究者合作,確保患者在入組試驗前充分理解其選項,並以嚴謹方式執行試驗,以維持整體試驗的完整性。

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • So that's with regard to the frontline PDAC and crossover risk on the expanded access program, it's an important program, important pathway for eligible patients before potential approval. Once an approval occurs, our patient support services team will work very closely with treating physicians and healthcare providers. And the intention here, of course, is to help minimize treatment interruptions, provide seamless transition of care over to commercial supply. That is a top priority for us. These patients will have access to our comprehensive patient support services, as we mentioned, the OnPath support that will include coverage navigation, financial assistance and adherence support.

    以上是關於一線 PDAC 與交叉風險。至於擴大用藥可近性計畫(expanded access program),這是一個重要計畫,也是潛在核准前符合資格患者的重要途徑。一旦獲得核准,我們的患者支援服務團隊將與主治醫師及醫療照護提供者密切合作。當然,我們的目標是盡量降低治療中斷,並讓照護能無縫轉換到商業供應。這是我們的最高優先事項之一。這些患者將可使用我們完整的患者支援服務;如我們所提到的 OnPath 支援,將包含給付範圍協助(coverage navigation)、財務協助以及用藥依從性支援。

  • We expect most patients would transition within a few month period.

    我們預期多數患者會在幾個月內完成轉換。

  • Operator

    Operator

  • Brian Cheng, JPMorgan.

    Brian Cheng,JPMorgan。

  • Brian Cheng - Analyst

    Brian Cheng - Analyst

  • Just first, on the EAP, can you talk about whether these patients are being recruited in the sites that have had prior daraxonrasib experience? And you noted that more than 90% of the requests have been accepted. What is the common reason for patients to get rejected?

    首先關於 EAP,你能談談這些患者是否主要在先前有 daraxonrasib 使用經驗的中心招募嗎?另外你提到超過 90% 的申請已被接受。患者被拒絕最常見的原因是什麼?

  • And then just one quick one on the 307 and 308 trial for frontline non-small cell trials. Are these studies setting any minimum or maximum threshold for the proportion of PD-L1 expression, depending on whether it's low or high that you're recruiting? Just curious if you can give us a sense of the trial design there would be great.

    再來快速一題,關於一線非小細胞肺癌的 307 與 308 試驗。這些研究在招募時,是否會依 PD-L1 表現比例(例如低或高)設定任何最低或最高門檻?想請你們簡單說明一下試驗設計,會很有幫助。

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Nicely done. I think you squeezed in three questions into two questions. Well done. Maybe Alan can comment first on the 307, 308 PD-L1 expression topic.

    做得很好。我覺得你把三個問題擠進兩個問題裡了。很棒。也許先請 Alan 針對 307、308 的 PD-L1 表現議題評論一下。

  • Alan Sandler - Chief Development Officer

    Alan Sandler - Chief Development Officer

  • Right. So yes, the -- we are not putting guidelines in terms of requirements of the numbers that have -- will let that play out in a large study such as Phase 3 study, there should be a natural -- a natural number of patients that appear on well representation of all three. What we will do, we generally want to stratify to make sure that there is equal representation on both arms. And I think that's the most important aspect of that.

    對。所以是的,關於——我們不會就這些數字的要求訂出指引——會讓它在像第三期這樣的大型研究中自然呈現,應該會有一個自然——自然的病人數量,能夠良好代表三個族群。我們會做的是,一般而言我們希望進行分層,以確保兩個治療組別都有同等代表性。我認為那是其中最重要的部分。

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • It's more about balance than anything else. Yes. Thanks, Alan. And then the -- on the EAP, there are participants in the program who have been investigators and have treated patients before, and there are participants who have not and significant numbers of both. I don't know that I can quantitate that for you, but I think we're experiencing both kinds.

    重點更多是在平衡,而不是其他。是的。謝謝你,Alan。然後關於——EAP(擴大使用計畫),計畫中的參與者有些是曾擔任研究者並且以前治療過病人的,也有些沒有,兩者的人數都不少。我不確定能否為你量化,但我想我們兩種情況都有遇到。

  • We've certainly put a lot of effort into providing education and support to all of the prescribers. So the experience that the more experienced providers have obtained, we've learned from -- we've all learned from, and we've developed protocols, approaches that we have invested heavily in developing and also conveying through education to anybody who might prescribe daraxonrasib. As to the greater than 90% rate, actually a very high rate as to who might be disapproved, it's really not subjective. It comes down to the eligibility criteria that are established in the FDA-cleared protocol. It's very well defined.

    我們確實投入了大量心力,為所有開立處方的醫師提供教育與支援。因此,較有經驗的醫療提供者所累積的經驗,我們也從中學習——我們都從中學到,並制定了流程與作法;我們在建立這些內容上投入很多,也透過教育傳達給任何可能開立 daraxonrasib 的人。至於大於 90% 的比例,實際上是非常高的比例,關於哪些人可能會被否決,其實並不主觀。關鍵在於 FDA 核准之方案(protocol)中所訂定的納入資格標準。定義得非常清楚。

  • There are very few edge cases where it requires some judgment. Most of it's really just making sure that somebody is actually eligible. And if they're eligible and the request comes through a US-licensed physician from a qualified institution that's met all the institutional requirements, then they will be approved.

    只有極少數邊緣案例需要一些判斷。大多數情況其實只是確認某人是否確實符合資格。如果符合資格,且申請是由美國執照醫師、來自符合條件且已滿足所有機構要求的機構提出,那麼就會獲得核准。

  • Operator

    Operator

  • Faisal Khurshid, Jefferies.

    Faisal Khurshid,Jefferies。

  • Faisal Khurshid - Equity Analyst

    Faisal Khurshid - Equity Analyst

  • There's been a lot of investor excitement about PRMT5 combination data generated with your molecule from your partner, Tango. Just want to understand from your perspective, what's your latest thoughts on the potential of that combination? And do you feel like you need a PRMT5 within your own portfolio in order to kind of cover all of your bases?

    投資人對你們合作夥伴 Tango 以你們分子所產生的 PRMT5 聯合治療數據非常興奮。想從你們的角度了解,你們對這個組合潛力的最新看法是什麼?以及你們是否覺得需要在自家產品組合中也擁有一個 PRMT5,才能算是把所有布局都補齊?

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Thanks for your questions. Yes, our position on PRMT5 inhibitors remains what it's been, which is that biologically, it's intriguing -- pharmacologically, it's intriguing hypothesis that's supported by preclinical work. Tango has now put forth some initial data that show high response rates. We think that body of evidence should be grown. And we know that Tango is working to do that, growing both in terms of numbers of patients, exposure to different dose levels, so dose optimization and a longer follow-up, and that will help us really establish a level of conviction about whether and if so, how to go forward with it.

    謝謝你的問題。是的,我們對 PRMT5 抑制劑的立場仍與先前一致:從生物學角度看很有意思——從藥理學角度看也是一個有吸引力的假說,且有臨床前研究支持。Tango 現在提出了一些初步數據,顯示很高的反應率。我們認為這些證據還需要擴充。我們也知道 Tango 正在努力做到這點,包含增加病人數、涵蓋不同劑量水準以進行劑量最佳化,以及更長期的追蹤;這將幫助我們真正建立信心,判斷是否、以及若要推進,該如何推進。

  • So certainly a credible idea, and we'll just continue to learn more about it as we support Tango in their efforts. With regard to do we need a PRMT5 inhibitor in our portfolio, I don't think we need it. We have plenty to do that's high priority within RevMed as we've described now one looks at the pipeline, it's a pretty rich pipeline of work. And the other thing to point out, of course, is that there are many PRMT5 inhibitors, growing number out there, each with a slightly different profile. some with more or less propensity to drug-drug interactions that would have to be managed, different levels of potency and so on.

    所以這確實是一個可信的想法;我們會在支持 Tango 推進的同時,持續學習更多。至於我們是否需要在產品組合中擁有 PRMT5 抑制劑,我不認為我們需要。如同我們所描述的,RevMed 內部有很多高優先事項要做;從研發管線來看,工作內容相當豐富。另外當然也要指出,市面上有許多 PRMT5 抑制劑,而且數量還在增加,每個的特性略有不同;有些較容易產生藥物—藥物交互作用、需要管理,效力水準也不同,等等。

  • So I think there's a lot of opportunity out there. I think at the end of the day, daraxonrasib should be the backbone of therapy for zoldonrasib in the context of the right settings, G12D selective setting. And we may add various things, whether it's PRMT5 inhibitors, immunologic agents, other RAS inhibitors, chemotherapy, et cetera, a wide variety of possibilities there.

    所以我認為外部有很多機會。我想最終 daraxonrasib 應該會在合適的情境下、在 G12D 選擇性設定中,成為 zoldonrasib 治療的骨幹。而我們可能會加入各種不同的東西,不論是 PRMT5 抑制劑、免疫相關藥物、其他 RAS 抑制劑、化療等等,有非常多的可能性。

  • Operator

    Operator

  • Michael Yee, UBS.

    Michael Yee,UBS。

  • Madeleine Lee - Analyst

    Madeleine Lee - Analyst

  • This is Madeleine on for Michael. Just wanted to get your -- any updated commentary around -- obviously, there is some precedent in oncology to get accelerated approval in the first line based on similar data to what you have, along with the full approval that you're expecting for the second-line PDAC indication. So just wondering if you have any updated commentary around that now that your NDA has been accepted by the FDA.

    我是 Madeleine,代 Michael 提問。想請教你們是否有任何更新的評論——顯然在腫瘤領域有一些先例,是基於與你們類似的數據在一線取得加速核准,同時你們也預期二線 PDAC 適應症能取得完整核准。所以想問在你們的 NDA 已被 FDA 受理之後,對此是否有任何更新的看法?

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Not really much to add to that. We're certainly aware of the history here. The NDA is primarily driven by the 302 data set, which is randomized data in patients being treated for second line -- in second line for metastatic pancreatic cancer. But there are additional data outside of that study that, of course, many people have access to, including the FDA, have access to it. And so how they want to deal with that, I think we'll just have to learn over time.

    這方面沒有太多可補充的。我們當然了解這裡的歷史先例。這份 NDA 主要是由 302 數據集所驅動,也就是在轉移性胰臟癌二線治療病人中的隨機分派數據。但除此研究之外,當然還有其他額外數據,很多人都能取得,包括 FDA 也能取得。至於他們想如何處理,我想我們只能隨時間推移再了解。

  • Operator

    Operator

  • Alec Stranahan, Bank of America.

    Alec Stranahan,美國銀行(Bank of America)。

  • Alec Stranahan - Analyst

    Alec Stranahan - Analyst

  • Two from us. First, on daraxonrasib in the metastatic RAS mutant lung cancer setting. Curious which data was shared with the FDA to support breakthrough therapy designation here? And if there's any read-through to be made to what we could see from RASolve 301. And I appreciate you probably aren't talking at all about pricing at this point.

    我們有兩個問題。第一個,關於 daraxonrasib 在轉移性 RAS 突變肺癌的情境。想了解你們向 FDA 分享了哪些數據,以支持這次的突破性療法認定?以及這是否能讓我們對 RASolve 301 可能看到的結果做一些推論?另外我也理解你們此時大概完全不會談定價。

  • But from a qualitative perspective, assuming initial approvals with the 300 mg dose, how would you think about relative price in combos that are investigating a lower daraxonrasib dose like in the PRMT5 studies? If you have any thoughts here that you could share, that would be great.

    但從定性角度來看,假設初期核准是以 300 mg 劑量為主,你們會如何看待在聯合療法中、例如 PRMT5 研究那種使用較低 daraxonrasib 劑量時的相對定價?如果你們有任何想法可以分享就太好了。

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • So the first question was what data did we share with the FDA? Well, it's kind of a general rule of thumb. You have to share pretty much everything with the FDA. So anything they want to look at, they look at. I don't think we can provide any more specificity around that, unfortunately.

    所以第一個問題是我們向 FDA 分享了哪些數據?嗯,這算是一個大致的經驗法則。你幾乎必須把所有東西都分享給 FDA。他們想看什麼就會看什麼。很遺憾,我想我們無法就此提供更具體的細節。

  • With regard to pricing, it's early for us to be talking about pricing. You're raising more of a kind of layered or nuanced question about pricing in combinations. And I guess I'd say the same thing. It's probably too early to be talking about that. We don't have a combination that's approaching commercialization today and nothing to address.

    至於定價,現在談定價對我們來說還太早。你提出的是一個更分層、或更細緻的問題:聯合療法中的定價。我想我會給出同樣的回答。現在談這個可能也還太早。我們目前沒有任何接近商業化的聯合療法,因此也沒有什麼可回應的。

  • I think you might have had another layer to it, but given that I didn't hit the first two layers, I'm not sure we'll make it to the third.

    我想你可能還有第三層的意思,但既然我前兩層都沒回答到,我不確定我們能不能進到第三層。

  • Operator

    Operator

  • Laura Prendergast, Stifel.

    Laura Prendergast,Stifel。

  • Laura Prendergast - Equity Analyst

    Laura Prendergast - Equity Analyst

  • Congrats on all the progress. I was hoping you could clarify what you mean by visibility into CRC development strategy expected in the fourth quarter. I guess the real question here is should investors expect to leave this update having conviction that you have a registrational path in CRC?

    恭喜你們取得所有進展。我希望你們能釐清一下,你們所說的「第四季預期能看到 CRC 開發策略的能見度」是什麼意思。我想真正的問題是,投資人是否應該預期在這次更新後,能有信心相信你們在 CRC 上有一條可註冊申請(registrational)的路徑?

  • And then second question is, do you guys have any plans to make a registrational move outside the big three RAS indications, kind of maybe bringing back that tumor-agnostic approach question. Is that something that we could see down the road once you've read out pivotal data for your first two PDAC and lung indications?

    接著第二個問題是,你們是否有任何計畫在三大 RAS 適應症之外推進註冊性(registrational)開發,某種程度上也算是回到先前提到的腫瘤無關(tumor-agnostic)策略問題。在你們針對首兩個 PDAC 與肺部適應症讀出關鍵性(pivotal)數據之後,未來是否有可能看到這樣的方向?

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Yes. Laura, thanks for your questions. Visibility into our development strategy we'll show some data, and we'll tell you what we plan to do with it. As to what investors will leave -- what impression they'll leave with that, that's up to investors to decide. I don't think it serves us to get out in front of that.

    是的。Laura,謝謝你的提問。關於我們開發策略的能見度,我們會展示一些數據,並告訴大家我們打算如何運用這些數據。至於投資人會帶著什麼樣的結論——或留下什麼樣的印象——那就由投資人自行判斷。我不認為我們提前把話說在前面對我們有利。

  • But that's our plan. And typically, in the past, when we've announced a development strategy, we've supported it by data that justify it. So I think that would be a reasonable expectation.

    但這就是我們的計畫。而且過去通常在我們宣布一項開發策略時,都會以能夠支持該策略的數據作為佐證。所以我認為這樣的期待是合理的。

  • Yes, regarding tumors outside of the big three, we're certainly interested in those. I mean our expectation is that daraxonrasib and other compounds as well, but daraxonrasib could serve a wide variety of tumors. Of course, there are smaller subsets of patients. And we have prioritized the big three as you put them, which makes sense to do. But we do have data across other tumor types.

    是的,關於三大適應症之外的腫瘤,我們當然也很有興趣。我的意思是,我們預期 daraxonrasib 以及其他化合物也一樣,但 daraxonrasib 可能適用於多種不同腫瘤。當然,那些會是較小的病人亞群。而我們已如你所說優先聚焦於三大適應症,這樣做是合理的。但我們確實也有涵蓋其他腫瘤類型的數據。

  • We've shown some of that data publicly. We have other data that hasn't yet made it out into the public domain. We have external research collaborations as ways to explore this.

    我們已經公開展示過其中一部分數據。我們還有其他尚未對外公開的數據。我們也透過外部研究合作來探索這些方向。

  • So, yes, I think you should expect that daraxonrasib will continue to make its way into other context. But the exact strategy by which we develop those may differ from indication to indication, context to context.

    所以,是的,我認為你可以預期 daraxonrasib 會持續被推進到其他情境中。但我們開發這些適應症的具體策略,可能會因適應症而異、因情境而異。

  • Operator

    Operator

  • Leonid Timashev, RBC.

    RBC 的 Leonid Timashev。

  • Leonid Timashev - Equity Analyst

    Leonid Timashev - Equity Analyst

  • Just wanted to ask on the commercial side. At least clinically, you guys have always been planning for success. I guess to what extent does that extend to the sales force sizing commercially? Are you planning a force that's commensurate with the second-line PDAC setting? Are you also going to size it for frontline and potentially non-small cell lung cancer right away?

    我想從商業端問一下。至少在臨床方面,你們一直都是以成功為前提在規劃。我想知道這在商業上對銷售團隊規模的規劃會延伸到什麼程度?你們是否規劃一支與二線 PDAC 市場相匹配的銷售團隊?你們也會一開始就把規模設計到能涵蓋一線治療以及潛在的非小細胞肺癌嗎?

  • Or is this going to expand later?

    還是之後再擴編?

  • And then maybe just a quick follow-up as well. Just on the EAP, are those 2,000 patient adds starting from May 1st-ish, when the FDA first made that announcement? I'm just trying to better understand sort of the cadence of how quickly patients came on.

    另外再快速追問一下。關於 EAP,那新增的 2,000 名病人是從 5 月 1 日左右、也就是 FDA 首次發布公告時開始計算的嗎?我只是想更了解病人納入的節奏,以及病人增加的速度。

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Well, I'll comment on the second one, and then Anthony Mancini can comment on the commercial organization. The number that I gave was greater than 2,000. So it wasn't 2,000, greater than 2,000. And that is a cumulative number. As you might recall, I think that once we filed the EAP request, it was approved within a couple of days.

    我先回應第二個問題,然後請 Anthony Mancini 回應商業組織的部分。我剛才給的數字是超過 2,000。所以不是 2,000,而是大於 2,000。而且那是累計數字。你可能記得,我想在我們提交 EAP 申請後,幾天內就獲得核准。

  • And I think within three weeks, we were shipping the first drug on behalf of patients. And it started out more as a trickle and then expanded as you'd expect over time as sites became part of the program, completed their process for entering the program. So I don't know that you can quite get a rhythm out of it other than to say qualitatively, it's a very robust program. There's very, very high interest in it, and it continues to grow.

    而且我想在三週內,我們就開始代表病人出貨第一批藥物。一開始比較像是涓滴式地進來,之後隨著時間推進、各中心加入計畫並完成其加入流程,規模就如預期擴大。所以我不確定你是否能從中抓到一個固定節奏;只能定性地說,這是一個非常強健的計畫。大家對它的興趣非常、非常高,而且仍在持續成長。

  • With regard to the commercial question, maybe Anthony can comment.

    至於商業面的問題,或許 Anthony 可以回應。

  • Anthony Mancini - Chief Global Commercialization Officer

    Anthony Mancini - Chief Global Commercialization Officer

  • Yes, Leonid, thanks for the question. We've been preparing for some time and are ready for a successful PDAC launch in the US. And as we think about commercialization infrastructure, there are parts of that commercialization infrastructure that are broad and that can apply to our future indications. But as for our sales force, which, as Mark alluded to in his prepared remarks, are fully trained and in place, we have a team of around 60 individuals that will fill the need for PDAC. But it's also important to note that there are many different stakeholders in the US market, and we're prepared for those as well.

    好的,Leonid,謝謝你的問題。我們已經準備了一段時間,並且已準備好在美國成功推出 PDAC 產品。當我們思考商業化基礎建設時,其中有些部分是較為通用的,也可以適用於我們未來的適應症。但就銷售團隊而言,正如 Mark 在事先準備的發言中提到的,我們的團隊已完成訓練並已就位;我們大約有 60 人的團隊,足以滿足 PDAC 的需求。同時也要注意,美國市場有許多不同的利害關係人,我們也已為此做好準備。

  • So we have a fully operational field access team field patient services team, MSL team and thought leader liaison team that are in place. We're excited and ready to go. All systems go. But yes, we're ready for PDAC, and we will be ready should other indications come.

    因此,我們已建立並全面運作的外勤市場准入團隊、外勤病人服務團隊、MSL 團隊以及意見領袖聯絡團隊。我們很期待,也已準備就緒。一切系統就緒。是的,我們已為 PDAC 做好準備;若未來有其他適應症到來,我們也會準備好。

  • Operator

    Operator

  • Kalpit Patel, Wolfe Research.

    Wolfe Research 的 Kalpit Patel。

  • Gugan Raghuraman - Analyst

    Gugan Raghuraman - Analyst

  • Gugan on for Kalpit. Just a quick one from us. Given Roche's head win against sotorasib and adagrasib in CRESCENDO-1, do you think you'd need to run a trial against divarasib?

    我是代 Kalpit 發問的 Gugan。我們這邊只有一個簡短問題。鑑於 Roche 在 CRESCENDO-1 中相較於 sotorasib 與 adagrasib 的正面結果(head win),你們認為是否需要進行一項與 divarasib 對照的試驗?

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Thanks for your question. Do you want to comment? The question is whether if divarasib is approved, I think, is what he's asking then would we be required to run an elironrasib frontline study against that?

    謝謝你的問題。你想回應一下嗎?他的問題是,如果 divarasib 獲批——我想他問的是這個——那我們是否會被要求在一線研究中,讓 elironrasib 與其進行對照?

  • Alan Sandler - Chief Development Officer

    Alan Sandler - Chief Development Officer

  • Yes. We'll be having all of our discussions with the FDA. We basically -- really the control arm is dictated by the current state of affairs at the time that the study is initiated, and that requires not necessarily a positive study, but that requires a full approval. And so since that's not the case at this time, we don't feel that that would be necessary.

    是的。我們會與 FDA 進行所有相關討論。基本上——實際上對照組是由研究啟動當下的現況所決定,而這不僅需要一項陽性研究,還需要完整核准(full approval)。因此,由於目前尚非如此,我們認為沒有必要。

  • Operator

    Operator

  • Thank you. This concludes the question-and-answer session. I would now like to turn it back to Dr. Mark Goldsmith for closing remarks.

    謝謝。問答環節到此結束。現在我想把時間交回給 Mark Goldsmith 博士做結語。

  • Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

    Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer

  • Thank you, operator, and thank you to everyone for participating today and for your continued support of Revolution Medicines.

    謝謝主持人,也謝謝各位今天的參與,以及各位對 Revolution Medicines 持續的支持。

  • Operator

    Operator

  • Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

    感謝各位參與今天的會議。本次議程到此結束。您現在可以掛線。