Exelixis Inc (EXEL) 2026 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Exelixis first quarter and fiscal year 2026 financial results conference call. My name is Sherry, and I'll be your operator for today. As a reminder, this call is being recorded for replay purposes.

各位女士、先生，大家好，歡迎參加 Exelixis 2026 會計年度第一季暨 2026 會計年度財務業績電話會議。我是 Sherry，今天將擔任會議接線員。提醒各位，本次電話會議將錄音，以供日後重播之用。

I would now like to turn the call over to your host for today, Mr. Andrew Peters, Senior Vice President of Strategy and Investor Relations. Please proceed.

現在我想把電話交給今天的主持人——策略與投資人關係資深副總裁 Andrew Peters 先生。請開始。

Thank you, Sherry, and thank you all for joining us for the Exelixis first quarter 2026 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO; and Chris Senner, our Chief Financial Officer; Dana Aftab, our Executive Vice President of Research and Development; and PJ Haley, our Executive Vice President of Commercial, who will review our progress for the first quarter 2026 and ended March 31, 2026.

謝謝你，Sherry，也感謝各位參加 Exelixis 2026 年第一季財務業績電話會議。今天與我一同出席的有：總裁暨執行長 Mike Morrissey；財務長 Chris Senner；研發執行副總裁 Dana Aftab；以及商務執行副總裁 PJ Haley。我們將回顧截至 2026 年 3 月 31 日止之 2026 年第一季的進展。

During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website for an explanation of our reasons for using such non-GAAP measures as well as tables deriving these measures from our GAAP results.

在今天的電話會議中，我們將提及若干非依一般公認會計原則（GAAP）計算的財務衡量指標。請參閱今日新聞稿（已發布於本公司網站），其中說明我們使用此類非 GAAP 指標的原因，並提供由 GAAP 結果推導至這些指標的對照表。

During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial and strategic matters, potential growth opportunities and government drug pricing policies and initiatives.

在本次簡報過程中，我們將就未來事件及公司未來表現作出前瞻性陳述。這包括有關探索、產品開發、法規監管、商業、財務與策略事項之可能進展、潛在成長機會，以及政府藥品定價政策與倡議的相關陳述。

Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the Securities and Exchange Commission, which under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including, without limitation, risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners and the level of cost associated with discovery, product development, business development and commercialization activities.

當然，實際事件或結果可能會有重大差異。我們請各位參閱我們不時向美國證券交易委員會（SEC）提交的文件；其中在「風險因素」項下，列示可能導致實際結果與公司今日口頭及書面表述存在重大差異的重要因素，包括但不限於：與產品商業成功、市場競爭、法規審查與核准流程、臨床試驗執行、遵循適用法規要求、我們對合作夥伴之依賴，以及探索、產品開發、商務拓展與商業化活動相關成本水準等風險與不確定性。

With that, I'll turn the call over to Mike.

接下來，我把電話交給 Mike。

All right. Thank you, Andrew, and thanks to everyone for joining us on the call today. Exelixis is off to a strong start in 2026, with meaningful progress across our discovery, development and commercial activities. Our strategy has a singular focus: to build a multi-franchise business in solid tumor oncology focused on GU and GI histologies based on the depth of the cabozantinib business, the potential breadth of the zanzalintinib opportunity and the scope of our early-stage pipeline.

好的。謝謝你，Andrew，也感謝各位今天加入我們的電話會議。Exelixis 在 2026 年有一個強勁的開局，我們在探索、開發與商業活動方面都取得了具意義的進展。我們的策略聚焦單一目標：在實體腫瘤腫瘤學領域打造多特許經營（multi-franchise）業務，聚焦泌尿生殖系（GU）與胃腸道（GI）組織學，並以 cabozantinib 業務的深度、zanzalintinib 機會的潛在廣度，以及我們早期研發管線的規模為基礎。

Key highlights for the quarter include: first, we saw a continued strong performance of the cabozantinib business in the first quarter of 2026. CABOMETYX continued to grow in revenue, demand, and market share as the leading TKI for RCC and the market leader for neuroendocrine tumors in the oral second-line plus segment. Importantly, we expedited the build out of our GI sales team in the first quarter to accelerate the growth of the CABOMETYX NET opportunity before zanza could come online for CRC later in 2026.

本季重點包括：第一，我們在 2026 年第一季看到 cabozantinib 業務持續強勁的表現。CABOMETYX 作為腎細胞癌（RCC）的領先 TKI，以及口服二線以上（second-line plus）區隔中神經內分泌腫瘤的市場領導者，其營收、需求與市占率持續成長。重要的是，我們在第一季加速擴建 GI 銷售團隊，以在 zanza 於 2026 年稍晚針對結直腸癌（CRC）上線之前，加快 CABOMETYX 在神經內分泌腫瘤（NET）機會的成長。

First quarter 2026, US cabo franchise net product revenues grew 8% year over year to $555 million compared to the first quarter of 2025. Continuing its role as a worldwide leading TKI, global cabo franchise net product revenues generated by Exelixis and its partners grew 12.5% year over year to $764 million in the first quarter 2026.

2026 年第一季，美國 cabo 特許經營之產品淨營收年增 8%，達 5.55 億美元，相較於 2025 年第一季。作為全球領先的 TKI，Exelixis 及其合作夥伴所產生的全球 cabo 特許經營產品淨營收在 2026 年第一季年增 12.5%，達 7.64 億美元。

Chris and PJ will share our financial and commercial highlights in their prepared remarks.

Chris 與 PJ 將在其事先準備的發言中分享我們的財務與商業重點。

Second, zanza is in the pull position as our next potential oncology franchise opportunity. The NDA for the zanza-atezo combination and third-line plus CRC based on the STELLAR-303 data is currently under review and is the top priority for the entire Exelixis organization. The zanza development program is rapidly advancing with seven ongoing or soon-to-start pivotal trials along with additional Phase II trials planned in prostate cancer and lung cancer. Dana will review the highlights for zanza and our extensive pipeline of early-stage assets in his prepared remarks.

第二，zanza 作為我們下一個潛在腫瘤學特許經營機會，已處於「拉動」（pull）態勢。基於 STELLAR-303 數據、用於三線以上（third-line plus）結直腸癌（CRC）的 zanza-atezo 聯合療法之新藥申請（NDA）目前正在審查中，並且是整個 Exelixis 組織的最高優先事項。zanza 的開發計畫正快速推進，目前有七項正在進行或即將啟動的關鍵性（pivotal）試驗，另規劃在前列腺癌與肺癌開展更多第二期（Phase II）試驗。Dana 將在其事先準備的發言中回顧 zanza 的重點，以及我們龐大的早期資產研發管線。

Third, the goal of our development effort is to establish zanza as the TKI of choice in the 2030s for RCC and other important indications that could surpass the impact of cabo in the 2020s. Zanza already has a meaningful development footprint in RCC with three ongoing Phase III studies across multiple lines of therapy, underscoring both the breadth of our ambition and the confidence we and others have in this molecule.

第三，我們開發工作的目標，是在 2030 年代將 zanza 建立為腎細胞癌（RCC）及其他重要適應症的首選 TKI，其影響力有望超越 cabo 在 2020 年代的表現。zanza 在 RCC 已具備相當的開發佈局，於多個治療線別有三項正在進行的第三期（Phase III）研究，凸顯我們企圖心的廣度，以及我們與其他各方對此分子的信心。

At the same time, as our experience with COSMIC-313 highlighted and was also recently seen with news from competitive trials, navigating the complexities of first-line RCC to improve upon existing regimens is a challenging endeavor at best and requires careful selection of combination partners to improve efficacy parameters, while managing tolerability and safety considerations. We remain committed to raising the bar in first-line RCC and continue to prioritize orthogonal MOAs to combine with zanza.

同時，正如我們在 COSMIC-313 的經驗所凸顯、且近期競爭性試驗的消息亦有所反映，在一線 RCC 中要在既有治療方案之上再提升，是一項充滿複雜性的挑戰，充其量也相當艱鉅；這需要審慎選擇聯合用藥夥伴，以提升療效指標，同時兼顧耐受性與安全性考量。我們仍致力於提高一線 RCC 的標準，並持續優先考量與 zanza 聯合的正交（orthogonal）作用機轉（MOA）。

In parallel, we seek to expand the breadth and depth of our zanza pivotal trial efforts, positioning zanza for durable leadership in RCC and other important tumor types.

與此同時，我們也尋求擴大 zanza 關鍵性試驗工作的廣度與深度，使 zanza 在 RCC 及其他重要腫瘤類型中具備長期領導地位的定位。

Fourth and finally, we remain committed to running the business at the highest level of efficiency as we advance our R&D priorities and at the same time, generate substantial free cash to invest in the pipeline to the right targeted BD at the right price to access external sources of innovation and to continue our share repurchase program, including an additional $750 million that was just authorized by the Exelixis Board.

第四也是最後，我們仍致力於以最高效率營運業務：在推進研發優先事項的同時，產生可觀的自由現金流，用以投資研發管線、以合適價格進行精準的商務拓展（BD）以取得外部創新來源，並持續執行庫藏股回購計畫；其中包括 Exelixis 董事會剛核准的額外 7.5 億美元回購額度。

So with that, see our press release issued an hour ago for our first quarter 2026 financial results and an extensive list of key corporate milestones achieved in the quarter.

因此，請參閱我們於一小時前發布的新聞稿，其中包含 2026 年第一季財務業績，以及本季達成之重要公司里程碑的完整清單。

And I'll now turn the call over to Chris.

接下來我把電話交給 Chris。

Thanks, Mike. For the first quarter of 2026, the company reported total revenues of approximately $611 million, which included cabozantinib franchise net product revenues of $555 million. CABOMETYX net product revenues were $552.8 million and included approximately $3.6 million in clinical trial sales. As a continued reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue into the future.

謝謝你，Mike。2026 年第一季，公司報告總營收約 6.11 億美元，其中包含 cabozantinib 特許經營產品淨營收 5.55 億美元。CABOMETYX 產品淨營收為 5.528 億美元，其中包含約 360 萬美元的臨床試驗銷售。再次提醒各位，臨床試驗銷售在季度之間歷來波動較大，我們預期未來仍將如此。

Gross to net for the cabozantinib franchise in the first quarter of 2026 was 30.2%, which is higher than the gross to net we experienced in the fourth quarter of 2025. This increase in gross to net deductions in the first quarter of 2026 is primarily related to higher 340B volume, higher Medicare Part D discounts and rebates and higher co-pay assistance when compared to the fourth quarter of 2025. Our CABOMETYX trade inventory was slightly lower at 2.1 weeks on hand at the end of the first quarter 2026 when compared to the fourth quarter of 2025.

2026 年第一季 cabozantinib 特許經營的毛額轉淨額（gross-to-net）為 30.2%，高於我們在 2025 年第四季所經歷的毛額轉淨額。2026 年第一季毛額轉淨額扣減增加，主要與 340B 量增加、Medicare Part D 折扣與回扣增加，以及與 2025 年第四季相比共同支付（co-pay）補助增加有關。於 2026 年第一季末，CABOMETYX 通路庫存（trade inventory）略為下降，手上庫存為 2.1 週，較 2025 年第四季為低。

Total revenues in the first quarter of 2026 also includes approximately $45.9 million in royalties earned from our partners, Ipsen and Takeda, on their sales of cabozantinib. Our total operating expenses for the first quarter of 2026 were approximately $359 million compared to $363 million in the fourth quarter of 2025. The sequential decrease in these operating expenses was primarily driven by lower clinical trial costs, offset by higher FTE-related costs and stock-based compensation expense.

2026 年第一季總營收亦包含約 4,590 萬美元的權利金，係由我們的合作夥伴 Ipsen 與 Takeda 就其 cabozantinib 銷售所支付。2026 年第一季總營業費用約 3.59 億美元，較 2025 年第四季的 3.63 億美元略降。營業費用的季減主要由臨床試驗成本降低所帶動，但部分被全職員工（FTE）相關成本上升及以股票為基礎之薪酬費用增加所抵銷。

Provision for income taxes for the first quarter of 2026 was approximately $57.2 million compared to a provision for income taxes of approximately $8.2 million for the fourth quarter of 2025. This increase in tax provision was related to certain items that were recognized in the fourth quarter of 2025.

2026 年第一季所得稅費用準備（provision for income taxes）約 5,720 萬美元，較 2025 年第四季約 820 萬美元的所得稅費用準備增加。此稅費準備的增加與 2025 年第四季認列的特定項目有關。

The company reported GAAP net income of approximately $210.5 million, or $0.81 per share basic and $0.79 per share diluted for the first quarter of 2026. The company also reported a non-GAAP net income of approximately $232.8 million, or $0.90 per share basic and $0.87 per share diluted. Non-GAAP net income excludes the impact of approximately $22.3 million of stock-based compensation expense net of the related income tax effect. Cash and marketable securities for the quarter ended March 31, 2026, was approximately $1.4 billion.

公司於 2026 年第一季報告 GAAP 淨利約 2.105 億美元，基本每股盈餘 0.81 美元、稀釋後每股盈餘 0.79 美元。公司亦報告非 GAAP 淨利約 2.328 億美元，基本每股盈餘 0.90 美元、稀釋後每股盈餘 0.87 美元。非 GAAP 淨利排除約 2,230 萬美元的以股票為基礎之薪酬費用（扣除相關所得稅影響後）的影響。截至 2026 年 3 月 31 日止季度，現金及有價證券約為 14 億美元。

During the first quarter of 2026, we repurchased approximately $430.8 million of the company's outstanding common stock, resulting in the retirement of approximately 10 million shares of the company's outstanding common stock at an average price per share of $42.99.

在 2026 年第一季期間，我們回購了約 4.308 億美元的本公司流通普通股，並以每股平均價格 42.99 美元註銷約 1,000 萬股本公司流通普通股。

As of the end of the first quarter 2026, we had approximately $159.4 million remaining under the $750 million stock repurchase plan authorized by the company's Board in October 2025. We expect to complete the October 2025 stock repurchase plan this month. Additionally, in May 2026, the company's Board authorized a new $750 million stock repurchase plan that expires on December 31, 2027.

截至 2026 年第一季末，依據本公司董事會於 2025 年 10 月核准的 7.5 億美元股票回購計畫，我們尚餘約 1.594 億美元可用額度。我們預期將於本月完成 2025 年 10 月的股票回購計畫。此外，於 2026 年 5 月，本公司董事會核准一項新的 7.5 億美元股票回購計畫，該計畫將於 2027 年 12 月 31 日到期。

And finally, we are reiterating our full year 2026 financial guidance, which is detailed on slide 16 of our earnings presentation. And with that, I'll turn the call over to PJ.

最後，我們重申 2026 全年財務指引，詳細內容載於我們財報簡報第 16 頁。接下來，我把電話交給 PJ。

Thank you, Chris. The CABOMETYX business continued to grow in the first quarter of 2026. The team is executing at an extremely high level with CABOMETYX continuing to be the number one prescribed TKI in renal cell carcinoma, the number one TKI plus IO combination in first-line RCC and the number one oral agent in second-line plus neuroendocrine tumors. Importantly, Q1 had the highest number of new patient starts in a quarter ever for CABOMETYX, representing strong momentum in the business.

謝謝你，Chris。CABOMETYX 業務在 2026 年第一季持續成長。團隊以極高水準執行，CABOMETYX 持續為腎細胞癌中處方量第一的 TKI、第一線 RCC 中 TKI 加 IO 組合的第一名，以及第二線加上神經內分泌腫瘤領域中處方量第一的口服藥物。重要的是，第一季 CABOMETYX 單季新增病患起始用藥數創下歷史新高，顯示業務動能強勁。

At the same time, CABOMETYX plus nivolumab had the highest quarterly first-line RCC market share to date. This is an exciting time for the team with zanzalintinib on the horizon as we prepare to launch our next franchise molecule, which would also expand the Exelixis GI franchise. The prescription data in the oral TKI market basket of cabo, lenvatinib, axitinib, sunitinib and pazopanib convey the strength of cabo relative to the competition.

同時，CABOMETYX 加 nivolumab 的第一線 RCC 單季市占率也創下迄今新高。對團隊而言，這是一個令人振奮的時刻；隨著 zanzalintinib 即將到來，我們正準備推出下一個特許經營（franchise）分子，亦將擴大 Exelixis 的 GI 特許經營版圖。口服 TKI 市場籃子（cabo、lenvatinib、axitinib、sunitinib 與 pazopanib）的處方數據，反映出 cabo 相較競品的優勢。

Looking at the TRx comparison of Q1 2025 to Q1 2026, CABOMETYX grew 3 share points from 44% to 47%. Additionally, CABOMETYX TRx volume grew 14% in Q1 2026 compared to Q1 2025, outpacing the growth rate of the market basket, which was 7% for the same period.

比較 2025 年第一季與 2026 年第一季的 TRx，CABOMETYX 的市占率提升 3 個百分點，從 44% 增至 47%。此外，2026 年第一季 CABOMETYX 的 TRx 量較 2025 年第一季成長 14%，超越同期間市場籃子 7% 的成長率。

Physicians are responding positively to the broad NET label and the contemporary trial design and perceive the efficacy and tolerability of cabo as favorable relative to other small molecule therapies in the space. Academic and community prescribers are using cabo broadly across patient and tumor characteristics, including patients with neuroendocrine tumors arising in the pancreas, GI tract and lung across all tumor grades, functional and SSTR status and those who have received prior treatment with LUTATHERA.

醫師對於廣泛的 NET 適應症標籤與當代試驗設計反應正面，並認為 cabo 的療效與耐受性相較該領域其他小分子療法更具優勢。學術與社區處方醫師廣泛將 cabo 用於不同病患與腫瘤特徵，包括源自胰臟、胃腸道與肺部的神經內分泌腫瘤患者，涵蓋所有腫瘤分級、功能性與 SSTR 狀態，以及曾接受 LUTATHERA 既往治療的患者。

Turning to new patient market share for second-line plus neuroendocrine tumors in the first quarter, we are pleased that CABOMETYX remains the market leader in the oral therapy segment. Additionally, our research indicates that there is opportunity to continue to grow market share, particularly in the community. For that reason, we expedited the expansion of our GI sales team in Q1, and the team was in the field, providing greater reach into the community in order to continue to grow net market share for CABOMETYX.

轉向第一季第二線以上神經內分泌腫瘤的新病患市占率，我們很高興 CABOMETYX 仍是口服治療領域的市場領導者。此外，我們的研究顯示仍有機會持續提升市占率，尤其是在社區端。因此，我們在第一季加速擴編 GI 銷售團隊，團隊已投入市場，以更深入觸及社區端，持續提升 CABOMETYX 的淨市占率。

Our new representatives joined us with significant oncology sales experience, particularly colorectal cancer and GI oncology.

我們的新進代表具備豐富的腫瘤銷售經驗，特別是在大腸直腸癌與 GI 腫瘤領域。

Importantly, the expanded team will be able to gain valuable experience selling cabo before we turn our focus to the potential launch of zanzalintinib in colorectal cancer. As we are thinking about building on and expanding our GI franchise, we are thrilled with the results of STELLAR-303 and a PDUFA date set for later this year. Pending regulatory approval, we believe that these data would provide Exelixis with a compelling commercial opportunity in one of the big four tumors.

重要的是，擴編後的團隊將能在我們把重心轉向 zanzalintinib 於大腸直腸癌的潛在上市之前，先累積銷售 cabo 的寶貴經驗。當我們思考如何建立並擴大 GI 特許經營時，我們對 STELLAR-303 的結果以及今年稍晚設定的 PDUFA 日期感到非常振奮。若獲監管核准，我們相信這些數據將為 Exelixis 在四大腫瘤之一帶來極具吸引力的商業機會。

Third-line plus CRC setting consists of approximately 23,000 patients in the US and represents an overall market opportunity of approximately $1.5 billion in terms of contemporary pricing.

美國第三線以上 CRC 的治療情境約有 23,000 名患者，按當前定價計算，整體市場機會約為 15 億美元。

Our market research and advisory boards demonstrate positive feedback and excitement for the STELLAR-303 data. Physicians reiterate the significant unmet medical need for patients in the third-line plus CRC setting and are excited for the potential to have an ICI option available for the broader population of CRC patients.

我們的市場研究與諮詢委員會顯示，對 STELLAR-303 數據的回饋正面且充滿期待。醫師再次強調第三線以上 CRC 患者存在顯著未被滿足的醫療需求，並對於有機會為更廣泛的 CRC 患者族群提供 ICI 選項感到興奮。

In closing, we are pleased with the growth of the cabo business, both in RCC and NET. In neuroendocrine tumors, prescribers see CABOMETYX as a more favorable choice versus other previously approved generic small molecule therapies.

總結而言，我們對 cabo 業務在 RCC 與 NET 的成長感到滿意。在神經內分泌腫瘤方面，處方醫師認為 CABOMETYX 相較其他先前核准的學名小分子療法是更有利的選擇。

Simultaneously, our internal team is in full launch preparation for zanza, and the excitement around these efforts is palpable. We look forward to the opportunity to launch the next Exelixis franchise later in the year to be able to help appropriate patients with colorectal cancer.

同時，我們內部團隊正全力進行 zanza 的上市準備，對這些工作的興奮之情溢於言表。我們期待今年稍晚有機會推出下一個 Exelixis 特許經營，以協助合適的大腸直腸癌患者。

Beyond STELLAR-303, we are enthusiastic about a significant development plan for zanza, which could position the zanza franchise and far exceed cabo in terms of the number of patients impacted across tumor types and settings.

除了 STELLAR-303 之外，我們也對 zanza 的重大開發計畫感到振奮；該計畫可望使 zanza 特許經營在不同腫瘤類型與治療情境中影響的患者數，遠超 cabo。

I will turn the call to Dana.

我把電話交給 Dana。

Thanks, PJ. Our strategy in R&D continues to focus on developing zanza as a multidimensional solid tumor oncology franchise molecule. And as you'll hear in my upcoming remarks, we continue to be focused on maximizing our productivity with disciplined investment in high-value opportunities for zanza as well as the rest of our portfolio.

謝謝，PJ。我們的研發策略持續聚焦於將 zanza 打造成多面向的實體腫瘤腫瘤學特許經營分子。如同你將在我接下來的說明中聽到的，我們仍專注於以審慎投資於 zanza 及我們其餘產品組合的高價值機會，來最大化生產力。

Today's update provides a little more clarity on the seven ongoing or soon-to-start pivotal studies for zanza. So my update today will be focused mostly on those trials, but I'll also spend some time on additional exploratory studies that we've designed to investigate zanza's potential in certain patients with prostate or lung tumors.

今天的更新讓大家對 zanza 目前進行中或即將啟動的七項關鍵性（pivotal）研究有更清楚的了解。因此，我今天的更新將主要聚焦於這些試驗，但我也會花一些時間談談我們設計的其他探索性研究，用以評估 zanza 在部分前列腺或肺部腫瘤患者中的潛力。

Starting with our NDA for zanza plus atezo in colorectal cancer, which is based on the results from the STELLAR-303 trial, our team has been highly engaged during the review process. And from our standpoint, the review has been proceeding on schedule towards the PDUFA date in early December.

先從 zanza 加 atezo 用於大腸直腸癌的 NDA 談起，該申請是基於 STELLAR-303 試驗結果；我們的團隊在審查過程中高度投入。就我們的觀點而言，審查正按進度推進，朝向 12 月上旬的 PDUFA 日期。

As a quick reminder, the trial has dual primary endpoints designed to assess overall survival, both in the broad intention to treat, or ITT, population, which includes patients both with and without liver metastases as well as more specifically in the population of patients without liver metastases, which we refer to as the NLM patients or population.

簡要提醒一下，該試驗設有雙主要終點，用以評估整體存活期：一是在廣泛的意向治療（intention to treat，ITT）族群（包含有與無肝轉移的患者），另一則更聚焦於無肝轉移的患者族群，我們稱之為 NLM 患者或族群。

The study met one of its dual primary endpoints, demonstrating a 20% reduction in the risk of death with the combination in the broad ITT population at the final analysis, while data pertaining to the other dual primary endpoint of overall survival in the NLM population showed a trend in overall survival favoring the combination. The NLM data were immature at the data cutoff, and the trial has been proceeding to the planned final analysis for this endpoint, and we continue to expect to have those top line results around the middle of this year, depending on event rates.

該研究達成其雙主要終點之一：在最終分析中，於廣泛 ITT 族群中顯示該組合可將死亡風險降低 20%；而另一個雙主要終點（NLM 族群的整體存活期）的數據則呈現整體存活期趨勢有利於該組合。由於在資料截止時 NLM 數據尚未成熟，試驗仍依計畫持續進行至該終點的最終分析；我們仍預期可在今年年中左右取得該終點的主要結果，視事件發生率而定。

The level of excitement here is really high right now about what a potential approval would mean for this large and underserved patient population. And as you heard from PJ, our preparations for launch are in full swing, so we'll be ready to go the moment we receive a positive decision. But as we've discussed since late last year, we believe there is significant additional franchise potential for zanza in colorectal cancer in an earlier stage of the disease.

目前大家對於潛在核准將為這個龐大且服務不足的患者族群帶來的意義感到非常振奮。如同你從 PJ 那裡聽到的，我們的上市準備正全面展開，因此一旦收到正面決定，我們就能立即啟動。不過，正如我們自去年底以來所討論的，我們相信 zanza 在大腸直腸癌更早期病程中仍具有顯著的額外特許經營潛力。

To realize that potential, our team has been highly focused on launching the STELLAR-316 trial, which will investigate zanza with and without an immune checkpoint inhibitor in patients with resected Stage II or III colorectal cancer who, following definitive therapy, have tested positive for molecular residual disease or MRD and have no radiographic evidence of disease.

為了實現該潛力，我們的團隊高度專注於啟動 STELLAR-316 試驗；該試驗將在已切除的第二期或第三期大腸直腸癌患者中，研究 zanza 合併或不合併免疫檢查點抑制劑的療效；這些患者在完成根治性治療後，分子殘存疾病（molecular residual disease，MRD）檢測呈陽性，且影像學上無疾病證據。

About 20% of patients are MRD positive following definitive therapy, and these patients typically have a poor prognosis with median disease-free survival times in the six- to eight-month timeframe. Critically, these patients have no therapeutic options that have been shown in a Phase III trial to prevent or delay metastatic progression of their disease. So this represents a significant opportunity in the colorectal cancer landscape.

約有 20% 的患者在完成根治性治療後為 MRD 陽性，而這些患者通常預後不佳，其中位無病存活期多落在 6 至 8 個月。關鍵的是，目前尚無任何已在第三期（Phase III）試驗中證實可預防或延緩其疾病轉移進展的治療選項。因此，這在大腸直腸癌治療版圖中代表一個重大機會。

As we've communicated in the past, MRD and STELLAR-316 will be determined with the Signatera circulating tumor DNA test with Natera as our diagnostic partner. Their database, built from testing thousands of patients each year, has been incredibly helpful to us in terms of prioritizing activation of clinical trial sites that are already known to have the highest cadence of testing and the highest numbers of eligible patients.

如同我們過去所溝通的，MRD 與 STELLAR-316 將使用 Signatera 循環腫瘤 DNA（ctDNA）檢測來判定，並由 Natera 擔任我們的診斷合作夥伴。他們的資料庫係由每年對數千名病患進行檢測所建立，對我們而言在優先排序臨床試驗中心的啟動上極具助益，因為這些中心已知具有最高的檢測頻率以及最多符合資格的病患數。

We're quite pleased with the level of enthusiastic feedback on STELLAR-316 that we've gotten from key opinion leaders and other stakeholders, and we are on track for initiating the trial around midyear.

我們對於從關鍵意見領袖與其他利害關係人所收到、針對 STELLAR-316 的熱烈回饋感到相當滿意，且我們正按計畫於年中左右啟動該試驗。

Moving on to kidney cancer, zanza's target profile, including the TAM kinases, MET and VEGF receptors, position zanza for success given the known roles played by these kinases in kidney tumors. STELLAR-304 is our first pivotal trial for zanza in kidney cancer, evaluating the combination of zanza plus nivolumab versus sunitinib in patients with locally advanced or metastatic non-clear cell renal cell carcinoma.

接著談腎癌，zanza 的目標特徵（包括 TAM 激酶、MET 與 VEGF 受體）使 zanza 具備成功的定位，因為這些激酶在腎腫瘤中已知扮演重要角色。STELLAR-304 是我們在腎癌領域針對 zanza 的首項關鍵性（pivotal）試驗，評估 zanza 合併 nivolumab 相較於 sunitinib，於局部晚期或轉移性非透明細胞腎細胞癌患者中的療效。

The non-clear cell RCC space is underserved with no positive readouts from a Phase III study specifically focused on these patients despite them representing approximately a quarter of all RCC cases. If positive, STELLAR-304 could potentially establish the first standard of care based on a randomized controlled Phase III trial for these patients.

非透明細胞 RCC 領域長期資源不足；儘管此類患者約占所有 RCC 病例的四分之一，但迄今尚無任何專門聚焦於這些患者的第三期研究取得正向讀出。若結果為正，STELLAR-304 可能有機會為這些患者建立首個以隨機對照第三期試驗為基礎的照護標準。

We completed enrollment last year, and given current event rates, we now expect top line results from the study in the second half of 2026. And if positive, those results could lead to our second NDA filing for zanza.

我們已於去年完成收案，依目前事件發生率推估，我們現在預期該研究將於 2026 年下半年公布主要結果（top line results）。若結果為正，這些結果可能促成我們為 zanza 提交第二件 NDA 申請。

In terms of opportunities in the clear cell RCC space, progress continues with regard to the two pivotal studies that Merck is running in clear cell RCC, evaluating zanza in combination with belzutifan. LITESPARK-033, which compares zanza plus bells versus cabo as first-line therapy in patients who received anti-PD-1 or anti-PD-L1 therapy in the adjuvant setting was initiated last year.

就透明細胞 RCC 的機會而言，Merck 正在透明細胞 RCC 中推進兩項關鍵性研究，評估 zanza 與 belzutifan 的合併治療，相關進展持續推動中。LITESPARK-033 於去年啟動，該研究比較 zanza 加 belz 與 cabo 作為第一線治療，用於在輔助治療（adjuvant）階段曾接受抗 PD-1 或抗 PD-L1 治療的患者。

In addition, Merck recently initiated LITESPARK-034, a global Phase III pivotal trial evaluating zanza plus belz versus belz plus placebo in second- or third-line patients with advanced RCC who have progressed on or after both anti-PD-1 or L1 and VEGFR TKI therapies, in sequence or in combination. We are certainly excited to see these Phase III studies in clear cell RCC moving forward, and based on our franchise experience in this indication, we believe there are other important opportunities to explore.

此外，Merck 近期啟動 LITESPARK-034，這是一項全球第三期關鍵性試驗，評估 zanza 加 belz 相較於 belz 加安慰劑，用於第二線或第三線之晚期 RCC 患者；這些患者在序貫或合併接受抗 PD-1 或 L1 與 VEGFR TKI 治療後，於治療期間或治療後出現疾病進展。我們對於這些透明細胞 RCC 的第三期研究持續推進感到非常振奮；並且基於我們在此適應症的產品線（franchise）經驗，我們相信仍有其他重要機會值得探索。

As we've mentioned previously, we continue to have discussions with potential collaborators to investigate novel combinations pairing zanza with other modalities and orthogonal mechanisms when there is strong scientific rationale for the combination. Given the demonstrated clinical differentiation we've seen with zanza and its potential to be the TKI of choice for combinations with immunotherapies and other mechanisms of action, we're looking to advance novel combinations in the future that have significant potential to move the needle for clear cell RCC patients. We hope to give further updates on these activities in the future as we get closer to launching the trials.

如同先前提到的，我們持續與潛在合作夥伴討論，在具備強而有力科學理據時，研究將 zanza 與其他治療模式及正交機制（orthogonal mechanisms）配對的創新合併療法。鑑於我們已觀察到 zanza 在臨床上的差異化表現，以及其作為與免疫療法及其他作用機轉合併之首選 TKI 的潛力，我們希望未來推進具顯著潛力、能為透明細胞 RCC 患者帶來實質改善的創新合併療法。隨著我們更接近試驗啟動，我們也希望未來能就這些活動提供進一步更新。

Moving on now to neuroendocrine tumors, STELLAR-311 is our Phase III trial evaluating zanza compared to everolimus as an initial oral therapy in patients with pancreatic or or extra-pancreatic neuroendocrine tumors. That study was initiated last year and we have been quite pleased by the state of enrollment in the trial. In fact, we are now far ahead of our initial enrollment projections. The sites and investigators are very enthusiastic about the trial given their growing experience with cabo in later-line disease and the opportunity presented by STELLAR-311 to improve on the current treatment landscape in earlier lines, which hasn't seen anything new for over a decade. That enthusiasm appears to be driving the very strong momentum we're seeing in the trial.

接著談神經內分泌腫瘤，STELLAR-311 是我們的第三期試驗，評估 zanza 相較於 everolimus，作為胰臟或胰外神經內分泌腫瘤患者的初始口服治療。該研究於去年啟動，我們對試驗的收案狀況感到相當滿意。事實上，我們目前的收案進度已大幅超前原先的收案預估。由於各試驗中心與研究者在後線治療中對 cabo 的使用經驗日益增加，且 STELLAR-311 提供了在較早治療線別改善現有治療版圖的機會（而該領域已超過十年未見任何新進展），因此他們對此試驗非常熱衷。這股熱情似乎正推動我們在試驗中看到的強勁動能。

Another opportunity for zanza that we've been discussing since late last year is in meningioma, which is the most common primary central nervous system tumor, accounting for approximately 40% of cases. Most meningiomas are benign, slow-growing neoplasms. However, up to 22% will recur after primary therapy, which consists of surgery and radiation. Importantly, there are no approved systemic therapies for meningioma that's refractory to local therapies, so this represents a very high unmet need in neuro-oncology.

另一個我們自去年底以來持續討論的 zanza 機會是在腦膜瘤（meningioma），其為最常見的原發性中樞神經系統腫瘤，約占病例的 40%。多數腦膜瘤為良性、成長緩慢的腫瘤。然而，最多有 22% 會在以手術與放射治療為主的初始治療後復發。重要的是，對於對局部治療無效（refractory）的腦膜瘤，目前並無任何核准的全身性治療，因此在神經腫瘤領域存在極高的未被滿足醫療需求。

Today, we announced that we have now initiated STELLAR-201, our Phase II trial evaluating zanza in patients with recurrent meningioma who are no longer responsive to or eligible for local therapies. The primary endpoint of the trial is objective response rate with secondary efficacy endpoints including duration of response, progression-free survival and overall survival. The trial will enroll up to 100 patients, and given the extremely high level of interest and enthusiasm for the trial among neuro-oncologists, we anticipate enrollment to be brisk. Pending favorable results and given the absence of any approved systemic therapies in this setting, the STELLAR-201 trial represents an important opportunity for zanza to become the first systemic therapy that could improve outcomes for these patients.

今天，我們宣布已啟動 STELLAR-201，這是我們的第二期試驗，評估 zanza 用於復發性腦膜瘤患者，這些患者已不再對局部治療有反應或不符合局部治療資格。該試驗的主要終點為客觀反應率（objective response rate），次要療效終點包括反應持續時間、無惡化存活期（PFS）與總存活期（OS）。本試驗將收納最多 100 名患者；鑑於神經腫瘤科醫師對此試驗展現極高的興趣與熱忱，我們預期收案將相當迅速。若結果良好，且考量此治療情境下缺乏任何核准的全身性療法，STELLAR-201 試驗代表 zanza 的一項重要機會，有望成為首個可改善這些患者預後的全身性治療。

Today, we also announced two additional studies exploring zanza combinations in indications where significant unmet need exists. STELLAR-202 is a planned Phase II trial in squamous non-small cell lung cancer that will explore the addition of zanza to pembro in the maintenance phase after induction with pembro plus chemotherapy. Part of the rationale for this trial comes from data we obtained from cabo plus atezo in the CONTACT-01 trial, where the subgroup of non-small cell lung cancer patients with squamous histology appeared to derive substantial benefit from the combination compared to chemotherapy.

今天我們也宣布另外兩項研究，探索 zanza 在存在顯著未被滿足醫療需求之適應症中的合併療法。STELLAR-202 是一項規劃中的第二期試驗，針對鱗狀非小細胞肺癌，將探索在以 pembro 加化療誘導治療後的維持期，於 pembro 基礎上加用 zanza。此試驗部分理據來自我們在 CONTACT-01 試驗中取得的 cabo 加 atezo 數據，其中鱗狀組織學的非小細胞肺癌患者亞群，相較於化療，似乎可從該合併療法中獲得顯著效益。

This is an important opportunity given the relatively short PFS in the maintenance setting and the lack of any new approvals in the frontline squamous non-small cell lung cancer since KEYNOTE-407 established the current standard of care with pembro plus chemo.

這是一項重要機會，因為維持治療情境下的 PFS 相對較短，且自 KEYNOTE-407 以 pembro 加化療確立現行照護標準以來，第一線鱗狀非小細胞肺癌尚未出現任何新的核准。

We're also planning an additional expansion cohort in the ongoing STELLAR-002 study to evaluate zanza in combination with docetaxel in patients with metastatic castration-resistant prostate cancer who have measurable disease. This is also based on initial observations with cabo, where a small Phase II study showed favorable outcomes when combined with docetaxel in metastatic CRPC patients. This cohort in STELLAR-002 is particularly meaningful because if zanza in combination with chemotherapy is shown to be safe and active, that could open up a number of opportunities across a range of solid tumors where chemo or potentially even ADCs carrying chemo payloads are standard of care.

我們也規劃在進行中的 STELLAR-002 研究中新增一個擴增隊列（expansion cohort），評估 zanza 與 docetaxel 合併用於具可測量病灶的轉移性去勢抗性前列腺癌（mCRPC）患者。此亦基於我們對 cabo 的初步觀察：一項小型第二期研究顯示，於轉移性 CRPC 患者中與 docetaxel 合併可帶來有利結果。STELLAR-002 的此隊列特別重要，因為若證實 zanza 與化療合併具安全性且具活性，將可能在多種實體腫瘤中開啟多項機會；在這些腫瘤中，化療或甚至可能是攜帶化療載荷（payload）的 ADC，皆為照護標準。

Our teams are super focused on launching these new studies soon, and we expect both to be initiated in the second half of this year.

我們的團隊正高度聚焦於盡快啟動這些新研究，並預期兩項研究都將於今年下半年啟動。

Now shifting to our early clinical pipeline, we have four molecules in this space that are currently in clinical development, namely XL309, XB010, XB628 and XB371. And the Phase I studies for these early molecules are progressing well.

接著轉向我們的早期臨床產品線（early clinical pipeline），目前有四個分子正在臨床開發中，分別為 XL309、XB010、XB628 與 XB371。而這些早期分子的第一期研究進展良好。

In terms of earlier-stage development candidates, we are continuing to advance exciting new small molecule and ADC programs, and I look forward to sharing more details as these early pipeline programs advance. Our strategy with the early pipeline is focused on identifying the next potential franchise molecules beyond cabo and zanza, so we will continue our approach of getting to go/no-go decisions quickly and efficiently, leveraging our expertise to pick the winners and ultimately maximize impact for patients.

就更早期的開發候選項目而言，我們持續推進令人振奮的新型小分子與 ADC 計畫，並期待隨著這些早期產品線計畫推進，能分享更多細節。我們的早期產品線策略聚焦於辨識 cabo 與 zanza 之外、下一個具潛力的產品線（franchise）分子，因此我們將持續採取快速且有效率地做出 go/no-go 決策的方法，運用我們的專業挑選勝出者，並最終為患者帶來最大的影響。

So with that, I'll turn the call back over to Mike.

那麼，接下來我把電話交回給 Mike。

All right. Thanks, Dana. I will wrap up here by thanking the entire Exelixis team for their outstanding efforts in the first months of 2026. We think 2026 could be a potentially transformational year for the company, and everyone at Exelixis is working together to move the needle for cancer patients and continue building value for all our stakeholders. We are focused on growing the cabo business while at the same time advancing zanza as our second potential franchise opportunity, all while continuing to investigate our early-stage pipeline.

好的。謝謝你，Dana。我在此做個總結，並感謝整個 Exelixis 團隊在 2026 年前幾個月所付出的傑出努力。我們認為 2026 年可能是公司具有轉型意義的一年，而 Exelixis 的每一位同仁都在共同努力，為癌症患者帶來實質改變，並持續為所有利害關係人創造價值。我們專注於成長 cabo 業務，同時推進 zanza 作為我們第二個潛在產品線（franchise）機會，並持續研究我們的早期產品線。

As always, I want to thank everyone at Exelixis for their individual and collective efforts, great teamwork and positive energy as we work every day to exceed expectations on our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.

一如既往，我想感謝 Exelixis 的每一位同仁，感謝大家個人與團隊的努力、出色的協作與正向的能量；我們每天都在努力超越期待，推進我們協助癌症病患更強健地康復並活得更久的使命。我們期待未來向各位更新我們的進展。感謝各位持續支持並關注 Exelixis；現在我們很高興開放電話會議進入提問環節。

Paul Choi, Goldman Sachs.

Paul Choi，高盛。

My question is for Dana. In light of the recent miss from the LITESPARK-012 study, can you maybe just comment on your updated thoughts or learnings from that trial result for your belzutifan plus zanza combination development program, specifically LITESPARK-033 and 034, and just any learnings or potential trial considerations that you've had in the wake of that data?

我的問題想請教 Dana。鑑於近期 LITESPARK-012 研究結果未達預期，您是否可以談談，這項試驗結果對於您們 belzutifan 加 zanza 的組合開發計畫（特別是 LITESPARK-033 與 034）所帶來的最新看法或學習？以及在這些數據出來之後，您們是否有任何新的學習或可能的試驗設計考量？

Thanks for the question, Paul. First of all, our strategy with zanza is to really focus on creating the next franchise molecule in RCC and the top TKI combination therapy in clear cell RCC in the 2030s. LITESPARK-012 was the triplet of pem/len plus belz versus pem/len, and as Mike mentioned earlier, triplet therapy in clear cell renal cell carcinoma is not an easy game. Our strategy is really focused on trying to establish a standard of care that covers multiple possible outcomes based on trials that are going on now. We have multiple shots on goal with LITESPARK-033 and -034. We have the STELLAR-304 data coming out, hopefully soon in non-clear cell renal cell carcinoma.

謝謝你的問題，Paul。首先，我們對 zanza 的策略，是專注於在 RCC 領域打造下一個系列（franchise）分子，並在 2030 年代於透明細胞型 RCC 中建立最頂尖的 TKI 聯合治療。LITESPARK-012 是 pem/len 加 belz 的三聯療法對比 pem/len；正如 Mike 先前提到的，在透明細胞腎細胞癌中做三聯治療並不容易。我們的策略重點，是嘗試建立一個能涵蓋多種可能結果的標準治療（standard of care），並以目前正在進行的試驗為基礎。我們在 LITESPARK-033 與 -034 上有多次機會（multiple shots on goal）。另外，我們也有 STELLAR-304 的數據即將公布，希望很快能在非透明細胞腎細胞癌中看到結果。

And as I mentioned earlier, we're evaluating a number of other potential novel and innovative combinations to further explore the clear cell RCC space, so that includes molecules from our own early pipeline. If XB628, which is our novel and innovative bispecific with multiple IO arms on it pans out, that could be a very interesting combination to explore in these patients. It would be very innovative, and nothing in that space has been explored so far.

此外，如我先前提到的，我們也在評估多種其他潛在的新穎且具創新性的組合，以進一步探索透明細胞 RCC 領域，其中也包括我們自家早期研發管線中的分子。如果 XB628（我們具新穎與創新性的雙特異性分子，並帶有多個 IO 作用臂）能夠成功，那將會是非常值得在這些病患中探索的有趣組合。這會非常創新，而且目前在該領域尚未有人探索過。

As Mike said earlier, we have multiple shots on goal to really establish and drive the zanza franchise into clear cell RCC in the future, especially focused on the 2030s, not on today, but on the 2030s.

如同 Mike 先前所說，我們有多次機會（multiple shots on goal）在未來真正建立並推動 zanza 系列進入透明細胞 RCC，特別是聚焦在 2030 年代——不是著眼於今天，而是著眼於 2030 年代。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Just two quick questions from us. One, if you could please provide some color on the contribution in renal cell carcinoma versus NET for cabo?

我們這邊有兩個簡短問題。第一，能否請您提供一些資訊，說明 cabo 在腎細胞癌（RCC）相較於 NET 的營收貢獻？

And then second, I recall that cabo failed as a monotherapy in advanced unselected non-small cell lung cancer and also on OS in Phase III for pancreatic, even though it showed a response in PFS. You touched on some of the combo regimens that have shown early data, but could you maybe expand on the rationale for testing combo therapies in STELLAR-202 and -002? Thank you.

第二，我記得 cabo 作為單藥在晚期、未篩選的非小細胞肺癌中失敗，且在胰臟癌的第三期試驗中 OS 也未達標，儘管在 PFS 上顯示反應。您提到了一些已有早期數據的聯合療法方案，但能否進一步說明在 STELLAR-202 與 -002 中測試聯合療法的理由？謝謝。

Yeah. Dana, why don't you take that second question first? And I think she was talking about prostate cancer, so what's the rationale for going into Phase II in non-small cell and then prostate cancer?

好的。Dana，要不你先回答第二個問題？我想他談的是前列腺癌，所以問題是：為什麼要在非小細胞肺癌進入第二期，然後又在前列腺癌進行？其背後的理由是什麼？

As I mentioned, the data that support our hypothesis for testing zanzalintinib in patients with non-small cell lung cancer comes from the CONTACT-01 study, which I think you're referring to. This is the Phase III study evaluating cabozantinib plus atezolizumab versus docetaxel in a broad population of non-small cell lung cancer patients.

如我所提到，支持我們在非小細胞肺癌病患中測試 zanzalintinib 這一假設的數據，來自 CONTACT-01 研究，我想你指的就是這個。這是一項第三期研究，評估 cabozantinib 加 atezolizumab 對比 docetaxel，涵蓋廣泛的非小細胞肺癌病患族群。

In that study, the subpopulation of patients with squamous histology actually did quite well and appeared to have a favorable benefit compared to the control arm in the study. For that reason, the STELLAR-202 trial is focused 100% on the squamous patient population with non-small cell lung cancer. In this population, the current standard of care is platinum-based chemotherapy plus pembrolizumab during induction, which is up to four cycles of chemotherapy or 12 weeks, and then they go on pembrolizumab maintenance. We are looking to add zanzalintinib onto the maintenance arm of pembrolizumab.

在該研究中，鱗狀細胞組織學（squamous histology）的病患亞族群表現其實相當不錯，與研究中的對照組相比似乎具有較有利的效益。因此，STELLAR-202 試驗 100% 聚焦於非小細胞肺癌的鱗狀病患族群。在這個族群中，目前的標準治療是在誘導期使用含鉑化療加 pembrolizumab，誘導期最多四個化療週期或 12 週，之後進入 pembrolizumab 維持治療。我們希望在 pembrolizumab 的維持治療階段加入 zanzalintinib。

We've already shown that zanza can sensitize patients to benefit with IO in the STELLAR-303 trial, a population of colorectal cancer patients that have historically been refractory to treatment with IO. We think this is a very rational exploration to pursue for these patients with squamous histology non-small cell lung cancer and high unmet need.

我們已在 STELLAR-303 試驗中證明 zanza 能讓病患對 IO 的治療效益更敏感；該試驗族群為結直腸癌病患，歷來對 IO 治療多呈現難治（refractory）。我們認為，對於這些鱗狀組織學的非小細胞肺癌且未被滿足需求很高的病患而言，這是一個非常合理的探索方向。

In prostate cancer, similarly, there was a small Phase I study combining cabozantinib with docetaxel. The Phase III trials that failed were not combining cabozantinib with chemotherapy. In the small Phase I, however, we saw very favorable outcomes in the patients that were treated in this small study. Based on the results from that, we believe there is rationale to pursue that combination in the Phase I STELLAR-002 trial.

在前列腺癌方面，同樣地，曾有一項小型第一期研究將 cabozantinib 與 docetaxel 合併使用。先前失敗的第三期試驗並未將 cabozantinib 與化療合併。然而在那項小型第一期研究中，我們在接受治療的病患身上看到了非常有利的結果。基於這些結果，我們認為在第一期 STELLAR-002 試驗中推進該組合具有合理性。

Once we get data showing safety and potentially activity of that combination, that opens up a lot of different avenues of exploration, either in castration-resistant prostate cancer, potentially in lung cancer and potentially in other indications where either chemo or chemo-based therapies, including ADCs, might be standard of care.

一旦我們取得顯示該組合具安全性、且可能具有活性的數據，就能開啟許多不同的探索途徑，例如在去勢抗性前列腺癌中、可能在肺癌中，以及可能在其他適應症中——在那些領域中，化療或以化療為基礎的治療（包括 ADC）可能是標準治療。

Sudan Loganathan, Stephens.

Sudan Loganathan，Stephens。

So my first one, I wanted to get your comments on the quantifiable metrics regarding cabo sales in NET, and how the sales team has grown over this time and how it will continue to?

第一個問題，我想請您評論一下關於 cabo 在 NET 的銷售之可量化指標，以及銷售團隊在這段期間如何擴編、未來又將如何持續擴編？

And then secondly, on zanza ahead of the CRC launch, what are some quantifiable metrics there as well that we can keep in mind ahead of the potential launch towards the end of this year?

第二個問題，關於 zanza 在 CRC 上市之前，有哪些同樣可量化的指標是我們在今年底潛在上市前可以先記在心上的？

Great. Thanks. PJ, do you want to take that one?

很好，謝謝。PJ，你要不要回答這題？

Thanks for the question. With regards to NET, we are really pleased with how the business is going. As I mentioned, overall in the first quarter, we had our highest new patient starts ever for CABOMETYX in a quarter, So that's certainly a really strong sign of the health of the business now and as those new patient starts ultimately translate to refills going forward, puts us in a really good position.

謝謝你的問題。就 NET 而言，我們對業務進展非常滿意。如我所提到，整體來看，在第一季我們創下 CABOMETYX 單季新病患啟用（new patient starts）的歷史新高，這無疑是目前業務健康度的一個非常強勁訊號；而隨著這些新病患啟用最終在未來轉化為續配（refills），也讓我們處於非常有利的位置。

Our business in NET is broad, as I mentioned in the prepared remarks, really across all segments and is viewed very favorably by physicians. Importantly, we are the market leader in the second-line plus oral segment. Our research and feedback really indicate that we have opportunity to continue to grow, particularly in the community setting, which is why we expedited the build-out of our GI sales force so we could really have that deeper reach into the community and drive further business there.

如我在事先準備的發言中提到，我們在 NET 的業務覆蓋面很廣，幾乎橫跨所有區隔，且在醫師間的評價非常正面。重要的是，我們在二線以上的口服用藥市場區隔中是市場領導者。我們的研究與回饋顯示，我們仍有持續成長的機會，特別是在社區醫療（community setting）中；這也是為什麼我們加速擴建 GI 銷售團隊，以便更深入觸及社區端並進一步帶動那裡的業務。

I'm really pleased to say that, as I mentioned, we brought in a very strong team with GI and CRC experience in sales, and we're really already seeing impact from that team. We're very, very pleased with that. Importantly, that team gets here and gets a chance to know the customers in the GI segment, gets experience selling cabo and a TKI, which is fantastic.

我也很高興地說，如我所提到的，我們引進了一支非常強的銷售團隊，具備 GI 與 CRC 的銷售經驗，而我們已經看到這支團隊帶來的影響。我們對此非常、非常滿意。重要的是，這支團隊加入後，有機會認識 GI 領域的客戶，並累積銷售 cabo 與 TKI 的經驗，這非常棒。

As we think about looking forward to the potential approval of zanza in CRC, which, as I mentioned, we're all really excited about. Our launch preparation is really in full swing, and the team is really focused on driving that forward. We're really excited to be able to optimize that launch and help patients with CRC. This is a really big and exciting opportunity for us in terms of the potential to be in one of the big four tumors of colorectal cancer. The third-line plus setting, as I mentioned, is 23,000 patients. As we look at that market in terms of contemporary pricing, that's a $1.5 billion opportunity.

當我們展望 zanza 在 CRC 可能獲批時——如我所提到的，我們都非常興奮——我們的上市準備已全面展開，團隊也正專注推進相關工作。我們非常期待能把這次上市最佳化，並幫助 CRC 病患。就我們而言，這是一個非常重大且令人振奮的機會，因為我們有潛力進入結直腸癌這四大腫瘤之一的領域。如我所說，三線以上的治療情境約有 23,000 名病患。以目前的定價水準來看，這是一個約 15 億美元的機會。

But really, the way we're thinking about zanza is, obviously, that initial launch will be really important, but we're also thinking about it in terms of franchises and how do we expand the CRC franchise with an earlier study such as STELLAR-316, and ultimately, how do we build it out in RCC, as Dana discussed, potentially in lung, meningioma, et cetera, with just so many exciting opportunities.

但我們對 zanza 的思考方式是：顯然，初期上市非常重要；同時我們也從系列（franchise）的角度思考——我們要如何透過像 STELLAR-316 這樣的更早期研究來擴大 CRC 系列，並最終如 Dana 所討論的，在 RCC 中建立版圖，且可能延伸到肺癌、腦膜瘤（meningioma）等，還有許多令人振奮的機會。

So really looking forward to getting going on them.

所以真的很期待能開始推進這些工作。

Sean Laaman, Morgan Stanley.

Sean Laaman，摩根士丹利。

This is Katherine on for Sean. We just had one on the updated STELLAR-304 data readout timing. Could you provide a bit more color on whether the slower event accrual reflects better-than-expected disease control? Was it a mix of the enrolled histologies or other trial dynamics?

我是代替 Sean 的 Katherine。我們剛剛問過一題關於更新後的 STELLAR-304 數據讀出時間點。能否再多提供一些背景，說明事件累積較慢是否反映疾病控制優於預期？這是否與入組的組織學類型組合或其他試驗動態有關？

And then as a quick follow-up, just given that the population is highly heterogeneous, how are you defining success against or across histologies? Are there specific subtypes where you believe the rationale is strongest here?

另外快速追問一下，鑑於該族群高度異質，你們如何在不同或跨組織學類型之間定義成功？是否有特定亞型是你們認為此處機轉理據最強的？

Sure. Thanks for the question, Katherine. Regarding -304, again, this is our Phase III study comparing zanzalintinib combined with nivolumab versus sunitinib. As such, it really is the first Phase III trial to address this high unmet need patient population. Currently, there is no Level 1 evidence supporting a standard of care in these patients. We see a huge opportunity here for the combination of zanza plus nivo.

好的。謝謝你的問題，Katherine。關於 -304，再次說明，這是我們的第三期研究，比較 zanzalintinib 聯合 nivolumab 與 sunitinib。就此而言，這確實是第一個針對這個高度未被滿足需求患者族群的第三期試驗。目前在這些患者中，尚無支持標準治療的第一級證據。我們看到 zanza 加上 nivo 的組合在此有巨大的機會。

Regarding the slight change in timing for events, I really don't want to speculate on what's driving that. We're just in the late stages of collecting events. As we mentioned, we expect to get those soon, sometime in the second half of the year.

至於事件時間點的些微變動，我真的不想臆測其背後原因。我們目前只是處於收集事件的後期階段。如同我們提到的，我們預期很快就會取得這些事件資料，大約在今年下半年某個時間點。

Andy Hsieh, William Blair.

Andy Hsieh，William Blair。

Just talking about the 316 for a little bit, there's an ad com recently that kind of talks about a definition of progression or change of therapy that's based on non-radiographic progression, so for the adjuvant CRC study, I'm just curious about the back and forth with the FDA agreeing on an MRD positivity as a way to change therapy?

稍微談一下 316。最近有一場諮詢委員會（ad com）討論了以非影像學進展為基礎的進展或更換治療定義；因此針對輔助治療的 CRC 研究，我想了解你們與 FDA 之間就以 MRD 陽性作為更換治療依據的來回溝通情況？

Could you educate us on what the dialogue was and then how you come to the conclusion that this is actually a regulatory approvable approach? Thank you.

能否跟我們說明對話內容，以及你們如何得出這其實是一個在法規上可獲核准的做法？謝謝。

Thanks, Andy. Dana, do you want to take that one?

謝謝，Andy。Dana，你要回答這題嗎？

Sure. Thanks for the question, Andy. We’ve discussed the STELLAR-316 trial since December last year. We're super excited about this study because it really addresses a high unmet need population. This is a population of patients who are resected Stage II or III colorectal cancer, have completed definitive therapy and now are in a watch-and-wait game to wait and see if they develop late-stage disease.

好的。謝謝你的問題，Andy。我們自去年 12 月以來就一直在討論 STELLAR-316 試驗。我們對這項研究非常興奮，因為它確實針對一個高度未被滿足需求的族群。這些患者是已切除的第二或第三期大腸直腸癌，已完成根治性治療，現在進入觀察等待階段，看看是否會發展成晚期疾病。

The Signatera test has shown in a number of different studies to, with a high degree of accuracy, predict rapid progression of patients. The patients who are positive for the test typically have a median disease-free survival of around six months, sot's a very high unmet need population. The trial has been well designed with a large degree of input from key opinion leaders, other stakeholders, as well as the agency.

Signatera 檢測在多項不同研究中已顯示能以很高的準確度預測患者的快速進展。檢測呈陽性的患者，其無病存活期（DFS）中位數通常約為六個月，因此這是一個高度未被滿足需求的族群。該試驗設計完善，並大量納入關鍵意見領袖、其他利害關係人以及主管機關的意見。

We're very, very confident in our design, and we're really excited to release more details as we get closer to launch. And when we do, you'll see a lot more design characteristics of the study, especially when it gets posted to clinicaltrials.gov. Just stay tuned for more information.

我們對設計非常、非常有信心，也很期待在接近啟動時公布更多細節。屆時你們會看到更多研究設計特徵，尤其是在 clinicaltrials.gov 上線後。請持續關注後續資訊。

Michael Schmidt, Guggenheim.

Michael Schmidt，Guggenheim。

I had a question on RCC. Just wanted to understand the size of the opportunity for the LITESPARK-033 study. What percentage of patients would be qualified for this? Beyond -033 and -034, are there any other studies you're considering for RCC, specifically with zanza?

我有一個關於 RCC 的問題。想了解 LITESPARK-033 研究的機會規模有多大？有多少比例的患者符合條件？除了 -033 和 -034 之外，你們是否還在考慮其他 RCC 研究，特別是與 zanza 相關的？

Thanks, Michael. PJ?

謝謝，Michael。PJ？

Thanks for the question. With regards to LITESPARK-033, and as we've talked about here, we're really thinking about RCC broadly as establishing zanza as a franchise in RCC and certainly beyond. That opportunity, as you look at the first-line setting, can be approximately a quarter of patients coming off of adjuvant therapy, and obviously, that can evolve as more and more patients are getting adjuvant therapy, but approximately a quarter of the first-line setting.

謝謝你的問題。關於 LITESPARK-033，如同我們在此討論的，我們確實是以更廣義的 RCC 來思考，目標是在 RCC 乃至更廣範圍內把 zanza 建立成一個產品線（franchise）。就機會而言，若看第一線治療情境，大約有四分之一的患者是從輔助治療後進入第一線；當然，隨著越來越多患者接受輔助治療，這個比例可能會演變，但目前約占第一線的四分之一。

I think the important thing, too, is really doing multiple studies as we've laid out in terms of LITESPARK-033, -034, STELLAR-304, and kind of drawing off our experience from cabo and how we did multiple studies in RCC to really establish ourselves as the leading TKI in the 20s here, and we're building towards our vision of establishing zanza as a leading TKI of the 30s.

我認為另一個重點是，如同我們所列出的 LITESPARK-033、-034、STELLAR-304，透過多項研究並行；同時借鏡我們在 cabo 的經驗——當時我們在 RCC 做了多項研究，才真正把自己建立為 2020 年代領先的 TKI——而我們正朝著願景前進，要在 2030 年代把 zanza 建立為領先的 TKI。

As Mike and Dana mentioned, we're looking at combinations with orthogonal MOAs and different approaches to continue to really raise the bar in the standard of care in the first-line setting in RCC generally.

如 Mike 和 Dana 所提到的，我們正在評估與作用機轉（MOA）互補的組合以及不同策略，以持續在 RCC 第一線整體標準治療上把門檻再往上提高。

Silvan Tuerkcan, Citizens.

Silvan Tuerkcan，Citizens。

I just want to ask a little bit broader around your strategy around resource allocation. You're running one of the broadest development strategies for an unapproved drug at this moment, and you even expanded it now. Obviously, you're sitting on a lot of data that we don't see, but that clearly make you very excited on zanza. How do you balance that broad strategy with buybacks and potential M&A, which hasn't happened yet? Thank you.

我想更廣泛地問一下你們在資源配置上的策略。你們目前對一個尚未核准的藥物採取了最廣泛的開發策略之一，而且現在還擴大了。顯然你們手上有很多我們看不到的數據，但那些數據顯然讓你們對 zanza 非常興奮。你們如何在這種廣泛策略與庫藏股回購以及潛在併購（目前尚未發生）之間取得平衡？謝謝。

Yeah. Silvan, thanks for the question. Chris, do you want to take that one?

是的。Silvan，謝謝你的問題。Chris，你要回答這題嗎？

Thanks for the question. From a capital allocation perspective, how we look at it is how do we allocate capital against R&D, how do we allocate capital against BD opportunities and then how do we allocate capital against share repurchases.

謝謝你的問題。從資本配置的角度來看，我們的思考是：如何在研發（R&D）上配置資本、如何在商務開發（BD）機會上配置資本，以及如何在股票回購上配置資本。

We’re a financially strong company. We have significant cash flows. We're prioritizing our R&D spend on a constant basis so that we're understanding what projects are sticking their heads up and saying fund us. We'll continue to do that.

我們是一家財務體質強健的公司，擁有可觀的現金流。我們會持續優先排序研發支出，以便了解哪些專案真正冒出頭來、在說「請資助我們」。我們會繼續這麼做。

Andrew, Stefan and the team are continuing to look at BD opportunities. We do have access to capital also, so we have a lot of things going on here that allows us to execute on all those three elements of R&D investments, BD investments and share buybacks. From a share buyback perspective, we believe that zanza is a great opportunity and that if that opportunity is not really being appreciated generally, we think we're undervalued, so we're going to continue to buy back shares.

Andrew、Stefan 以及團隊也持續在尋找 BD 機會。我們同時也有資金取得管道，因此我們有很多事情在進行，使我們能在研發投資、BD 投資與股票回購這三個面向同時執行。就股票回購而言，我們認為 zanza 是一個很好的機會；如果市場整體並未充分反映這個機會、我們認為公司被低估，那我們就會持續回購股票。

Jason Gerberry, Bank of America.

Jason Gerberry，美國銀行。

This is Chi for Jason. My question is on LITESPARK-034. Can you contextualize the choice of using belzutifan monotherapy as the control arm as opposed to an alternative TKI monotherapy or perhaps even belzutifan plus lenvima given the pending sNDA review there?

我是代替 Jason 的 Chi。我的問題是關於 LITESPARK-034。你能否說明為何選擇以 belzutifan 單藥作為對照組，而不是其他 TKI 單藥，或甚至考慮到該組合正在進行 sNDA 審查而使用 belzutifan 加 lenvima？

I also noticed that OS is listed as a dual primary endpoint. Would PFS alone be sufficient to support approva, or would you need an OS win there? So just again, thinking about both likelihood of success and regulatory bar based on the recent LITESPARK-011 data?

我也注意到 OS 被列為雙主要終點之一。僅以 PFS 是否足以支持核准，還是需要 OS 也獲勝？因此想請你再談談，基於近期 LITESPARK-011 數據，成功機率與法規門檻各是如何？

Yeah. Dana, go ahead.

好。Dana，你來。

LITESPARK-034 is Merck study. As you mentioned, it's evaluating zanza plus belz versus belz plus placebo in the second-line plus setting in patients who have progressed both on an IO-based regimen and a VEGFR TKI regimen, either in sequence or in combination.

LITESPARK-034 是 Merck 的研究。如你所提到的，它評估的是 zanza 加 belz，對比 belz 加安慰劑，用於第二線及以上的患者；這些患者在以 IO 為基礎的療法以及 VEGFR TKI 療法上都已進展，可能是序貫使用或合併使用。

The dual primary endpoints are two different efficacy endpoints. In clear cell RCC, OS has really become a gold standard, so having two different efficacy endpoints in the trial typically requires both to hit, but it really depends on the data, right? It's always data dependent and the timing of when those results come in.

雙主要終點是兩個不同的療效終點。在透明細胞 RCC 中，OS 的確已成為黃金標準，因此試驗若設有兩個不同的療效終點，通常需要兩者都達標；但這其實取決於數據本身，對吧？一切都取決於數據，以及結果出來的時間點。

Regarding the population, this study, as well as many other studies that are ongoing now or planned for the future, really anticipates multiple potential treatment landscapes for patients. This is really in the landscape of patients who are really going to be candidates for belzutifan alone or belzutifan in combination with a TKI. These are typically patients who have already progressed on a TKI-containing regimen and an IO-containing regimen, so that really should be an important opportunity and important unmet need when this trial reads out.

至於族群，這項研究以及許多目前進行中或未來規劃的研究，都是在預期患者可能面臨多種治療版圖的前提下設計的。這主要針對那些可能適合使用 belzutifan 單藥或 belzutifan 聯合 TKI 的患者情境。這些通常是已在含 TKI 的方案與含 IO 的方案上進展的患者，因此當本試驗讀出時，這應該會是一個重要的機會點與重要的未被滿足需求。

Leonid Timashev, RBC.

Leonid Timashev，RBC。

I want to stick with the franchise approach by 2030 that you've been talking about. I mean, you mentioned CRC, but I wanted to focus on NETs and how you're thinking about the franchise there in the future. I mean, you're running 311, but are there any other combinations that you're looking at, especially as the treatment landscape evolves with radiopharmaceuticals and ADCs? How are you envisioning building out zanza into the 2030s?

我想延續你們一直在談的、到 2030 年的產品線（franchise）策略。我知道你們提到了 CRC，但我想聚焦在 NETs，以及你們如何思考未來在那裡建立產品線。我是說，你們在做 311，但是否還有其他你們正在看的組合，特別是在放射性藥物與 ADC 使治療版圖演進的情況下？你們如何構想在 2030 年代把 zanza 擴展起來？

Yeah. Thanks for the question. Why don't we tag team this? PJ, why don't you go first and then Dana can add some commentary?

是的。謝謝你的提問。我們要不要分工回答？PJ，你先開始，然後 Dana 再補充一些評論？

Thanks for the question, Leonid. With regards to the way we're thinking about 311 in the marketplace, as I mentioned, cabo is off to a really strong start in terms of kind of the second-line plus setting. That study is designed specifically to go head-to-head with everolimus as an active comparator, which is a first in the setting.

謝謝你的提問，Leonid。關於我們如何看待 311 在市場上的定位，如我提到的，cabo 在第二線以上治療情境的定位上有非常強勁的開局。該研究是特別設計用來與 everolimus 進行正面對決、以其作為主動對照（active comparator），這在該治療情境中是首次。

We’re really positioning that patient population in the first or second-line setting, so earlier lines of therapy and then a larger patient population. There’s really potential to beat an active comparator head-to-head and a lot of excitement around the study design, as Dana mentioned in his prepared remarks. We’re excited about that zanza opportunity.

我們確實把該患者族群定位在第一線或第二線治療情境，也就是更早期的治療線別，且對應更大的患者族群。這項研究有很大潛力在與主動對照的正面比較中勝出，且如 Dana 在事先準備的發言中提到的，大家對研究設計非常振奮。我們對那個 zanza 的機會感到興奮。

Beyond that, I'd say that we are very committed to this patient population. We've seen how much benefit cabo is bringing to the table for these patients. We've seen the excitement around STELLAR-311. We're really focused on how else we can really address this patient population.

除此之外，我想說我們對這個患者族群非常投入。我們已看到 cabo 為這些患者帶來多大的效益。我們也看到市場對 STELLAR-311 的興奮。我們非常專注於還能如何進一步服務這個患者族群。

As we discussed at R&D Day, we're also looking at a number of other potential opportunities earlier in the discovery pipeline to either address specifically the neuroendocrine tumor patients who require treatment also with an SSTR2 agonist, these are mainly patients with functional tumors, and also any other patients who express the receptor and are known to be potentially sensitive to that type of treatment. We're developing a small molecule that we hope to file an IND on later this year that could be a novel approach to offer in combination with zanza. If the STELLAR-311 trial is successful, we might do that type of combination in the future.

如同我們在 R&D Day 討論的，我們也在研發管線更早期的探索階段評估多個潛在機會：要嘛是專門針對需要同時以 SSTR2 促效劑（agonist）治療的神經內分泌腫瘤患者（主要是功能性腫瘤患者），要嘛是任何其他表現該受體、且已知可能對此類治療敏感的患者。我們正在開發一個小分子，期望在今年稍晚提交 IND，作為可與 zanza 聯合使用的全新策略。若 STELLAR-311 試驗成功，未來我們可能會進行這類聯合治療。

Broadening out to other types of neuroendocrine carcinomas, this is namely tumors that express DLL3, so primarily small cell lung cancer, but a range of other neuroendocrine carcinomas that occur throughout the body in the GI tract and in the prostate. That molecule, we presented some data at AACR this year, XB773. It's a DLL3 targeted ADC with a very novel format. It's a very small format with a topoisomerase inhibitor payload that we think is differentiated versus the other competitive molecules that are in the space right now.

再擴大到其他類型的神經內分泌癌，主要是表現 DLL3 的腫瘤，因此以小細胞肺癌為主，但也涵蓋一系列發生於全身、包括胃腸道與前列腺的其他神經內分泌癌。我們今年在 AACR 發表了一些該分子 XB773 的數據。它是一個靶向 DLL3 的 ADC，採用非常新穎的形式。它的形式非常小，並搭載拓撲異構酶抑制劑（topoisomerase inhibitor）作為載荷（payload），我們認為相較於目前同領域的其他競品分子具有差異化。

That molecule can be quite exciting once we generate some data. If it does stand up and show some interesting activity, there we can also explore combinations with zanza. We have multiple irons in the fire exploring this space across histologies and different patient populations.

一旦我們產出一些數據，這個分子可能會相當令人振奮。如果它能站得住腳並顯示出有趣的活性，我們也可以探索與 zanza 的聯合治療。我們在這個領域跨不同組織學類型與不同患者族群同時推進，多線並進。

Kalpit Patel, Wolfe Research.

Kalpit Patel，Wolfe Research。

I have one on the LITESPARK-012 trial. There was no benefit of the triplet there compared to the doublets in that first-line setting, so I guess for your and Merck's strategy, would you ever entertain a triplet in that exact same first-line setting? What would that future study look like in CRC?

我有一題關於 LITESPARK-012 試驗。在第一線治療情境中，三聯療法相較於雙聯療法沒有顯示獲益，所以我想問就你們與 Merck 的策略而言，你們是否會考慮在完全相同的第一線治療情境中再做三聯？未來在 CRC 的研究會長什麼樣子？

Go ahead.

請說。

Yes, I'll take the question, Kalpit. Thanks for the question. As you know, we are collaborating with Merck on LITESPARK-033, which is evaluating zanza plus belz in the frontline setting, and that's versus cabozantinib. Slightly different hypothesis that's being addressed here, there's no IO in this combination because it's requiring patients to come in after having been treated in the adjuvant setting with IO.

好的，Kalpit，我來回答。謝謝你的提問。如你所知，我們正與 Merck 合作進行 LITESPARK-033，評估 zanza 加 belz 在第一線治療情境中的表現，並與 cabozantinib 進行比較。這裡檢驗的是稍微不同的假設；這個組合中沒有 IO，因為它要求患者是在輔助治療（adjuvant）階段已接受過 IO 之後才入組。

Looking at other potential combinations beyond this, especially triplets, they requiresa lot of very specific and focused scientific rationale, so we're not opposed to doing it. It just has to be the right molecule in the right setting. As I mentioned in my prepared remarks, we have been looking at a lot of orthogonal MOAs to pair with zanzalintinib in this space as well as we're going to be investigating the combination of zanza plus our own novel bispecific IO in its Phase I study. We're pending more discussions and more data that we can generate in Phase I, and we'll reveal or disclose more details about any of those trials as they come to fruition and get closer to launch.

至於除此之外的其他潛在聯合治療，特別是三聯療法，需要非常具體且聚焦的科學理據，因此我們並不排斥去做；只是必須是在正確的治療情境中搭配正確的分子。如我在事先準備的發言中提到的，我們一直在評估多種可與 zanzalintinib 搭配的正交作用機制（orthogonal MOAs），同時也將在我們自有的新型雙特異性 IO 的第一期研究中，探索 zanza 與其聯合治療。我們仍待進一步討論並在第一期產出更多數據；隨著這些試驗逐步成形並接近啟動，我們會揭露或披露更多細節。

Etzer Darout, Barclays.

Etzer Darout，Barclays。

First, how are you thinking about how are you planning to leverage the non-liver met data from STELLAR-303 given the December PDUFA date? Are you going to update your NDA to include that data? And then it would be interesting to hear your thoughts around the investigator-sponsored trial coming up at ASCO of cabo/nivo in non-clear cell renal cell carcinoma and how to think about that data set relative to zanza and 304.

第一，你們如何思考、以及計畫如何運用 STELLAR-303 的非肝轉移（non-liver met）數據，考量到 12 月的 PDUFA 日期？你們會更新 NDA 以納入該數據嗎？另外，也想聽聽你們對即將在 ASCO 發表、由研究者發起的 cabo/nivo 用於非透明細胞腎細胞癌試驗的看法，以及如何將那組數據相對於 zanza 與 304 來解讀。

Dana, go ahead.

Dana，請說。

Thanks for the question. Regarding the STELLAR-303 trial, as I mentioned, we are on track to see those results of the non-liver metastasis subgroup. The primary endpoint that's focused on that subgroup around midyear this year, we're still on track for that.

謝謝你的提問。關於 STELLAR-303 試驗，如我提到的，我們預期將看到非肝轉移亞組的結果，且仍按計畫在今年年中讀出該亞組的主要終點（primary endpoint），目前進度仍在軌道上。

Regarding the data and sharing with the FDA, we certainly plan to share those data as well as any other data that the agency might ask for as part of the ongoing review. And again, as I mentioned, from our standpoint, that review is progressing on schedule toward the PDUFA date in early December.

至於數據以及與 FDA 的分享，我們當然計畫分享這些數據，以及審查過程中主管機關可能要求的任何其他數據。再次強調，從我們的角度來看，審查正按既定時程推進，朝向 12 月初的 PDUFA 日期。

Ash Verma, UBS.

Ash Verma，UBS。

I wanted to just get the latest thoughts on cabo competitiveness in RCC given the LISPARL-022 study that had a PFS positive. Do you think it's unlikely to show OS separation because there isn't enough attribute to that analysis?

我想了解一下在 RCC 中 cabo 的競爭力最新看法，考量到 LISPARL-022 研究的 PFS 呈陽性。你是否認為它不太可能在 OS 上拉開差距，因為那個分析沒有足夠的歸因（attribute）？

PJ?

PJ？

Thanks for the question. We're really pleased with where we are competitively in RCC. Generally, I wouldn't want to speculate on how other trials continue to read out their data, but what I'll say is, as we talked about earlier on building a franchise, we've done so many studies in RCC that we have strength of the business really in every segment.

謝謝你的提問。我們對於在 RCC 的競爭態勢感到非常滿意。一般而言，我不想臆測其他試驗後續讀出數據的結果；但我想說的是，如同我們先前談到建立產品版圖（franchise），我們在 RCC 做了非常多研究，因此我們的業務在各個細分領域都很有實力。

We saw this quarter the highest frontline market share for CABOMETYX plus nivolumab in the first-line setting, which we're very pleased with. We continue to see strong momentum there in the first-line setting, given just sort of the breadth and depth of the data and also the experience that prescribers have using this combination now for so many years. We see potential to continue growing in RCC, and particularly in the first-line setting.

本季我們看到 CABOMETYX 加 nivolumab 在第一線治療情境的市占率創下新高，我們對此非常高興。鑑於數據的廣度與深度，以及處方醫師多年來使用這個組合的經驗，我們持續看到第一線治療情境的強勁動能。我們認為在 RCC 仍有持續成長的潛力，尤其是在第一線治療情境。

At this time, there are no further questions. And so I will turn the call over to today's host, Andrew Peters. Mr. Peters?

目前沒有其他問題了。接下來我把電話會議交回給今天的主持人 Andrew Peters。Peters 先生？

Yeah. Thank you, Sherry, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were unable to address during today's call. Thank you all again, and have a great rest of your week.

是的。謝謝你，Sherry，也謝謝各位今天加入。我們也歡迎各位就今天會議中未能回答的其他問題進行後續來電。再次謝謝大家，祝各位本週接下來一切順利。

This concludes today's program. Thank you all for participating. You may now disconnect.

今天的活動到此結束。感謝各位參與。您現在可以掛線。