Summit Therapeutics Inc. (SMMT) 2026 Q2 法說會逐字稿

Good afternoon and welcome to Summit Therapeutics' Q2 2026 earnings call.

下午好，歡迎參加 Summit Therapeutics 2026 年第二季財報電話會議。

(Operator Instructions) Please note that today's call is being recorded. (Operator Instructions)

(接線員指示) 請注意，今天的電話會議將被錄音。(接線員指示)

At this time, I would like to turn the call over to Dave Gancarz, Summit Therapeutics' Chief Business and Strategy Officer. You may proceed.

此刻，我想將電話會議交給 Summit Therapeutics 首席商務與策略長 Dave Gancarz。請開始。

Good afternoon and thank you for joining us. On today's call, we will provide an update on our second-quarter 2026 finance and operational progress.

下午好，感謝各位加入我們。在今天的電話會議中，我們將提供 2026 年第二季財務與營運進展的最新資訊。

This afternoon's press release is available on our website, www.smmttx.com. Our Form 10-Q was also filed today and is available on our website and via the SEC's website.

今天下午的新聞稿已發布於我們的網站 www.smmttx.com。 我們的 Form 10-Q 也已於今日提交，並可在我們的網站以及美國證券交易委員會（SEC）網站上查閱。

Today's call is being simultaneously webcast. An archived replay will also be made available later today on our website.

今天的電話會議同步進行網路直播。稍晚今天也將在我們的網站提供存檔重播。

Joining me on the call, today, is Bob Duggan, our Chairman of the Board and Co-Chief Executive Officer; Dr. Maky Zanganeh, our President and Co-Chief Executive Officer; Manmeet Soni, our Chief Operating Officer and Chief Financial Officer; and Dr. Allen Yang, Chief of R&D Strategy. I'm

今天與我一同參與電話會議的有：董事會主席暨共同執行長 Bob Duggan；總裁暨共同執行長 Maky Zanganeh 博士；營運長暨財務長 Manmeet Soni；以及研發策略主管 Allen Yang 博士。我

Dave Gancarz, the Chief Business and Strategy Officer here at Summit.

是 Summit 的首席商務與策略長 Dave Gancarz。

Before we get started with the rest of the call, I would like to note that some statements made by our management team and some responses to questions that we make today may be considered forward-looking statements, based on our current expectations.

在我們開始接下來的會議內容之前，我想提醒各位：我們管理團隊今天所做的部分陳述，以及我們今天對問題的部分回應，可能構成以前瞻性陳述，係基於我們目前的預期。

Summit cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements.

Summit 提醒，這些前瞻性陳述受到風險與不確定性影響，可能導致實際結果與前瞻性陳述所示有重大差異。

Please refer to our SEC filings for information, including the Form 10-Q issued today, about these risks and uncertainties. Summit undertakes no obligation to update these forward-looking statements, except as required by law.

有關這些風險與不確定性的資訊，請參閱我們向 SEC 提交的文件（包括今日發布的 Form 10-Q）。除法律要求外，Summit 不承擔更新這些前瞻性陳述的義務。

One item of note: This presentation is being webcast with slides so we'll be referring to the slides being displayed in the web link. I'd encourage you to use the webcast link to see the slides being presented this afternoon that will accompany our comments.

另外提醒一點：本次簡報將以投影片搭配網路直播，因此我們會參照網路連結中顯示的投影片。我鼓勵各位使用網路直播連結觀看今天下午隨我們發言一同呈現的投影片。

Following comments from our team, we will take questions.

在我們團隊發言結束後，我們將開放提問。

With that, I'll hand it over to Bob.

接下來，我把時間交給 Bob。

Thank you, Dave. Good afternoon, everyone. Thank you for joining us today.

謝謝你，Dave。各位下午好。感謝各位今天加入我們。

I'm very proud of the highly focused, mission-driven, patient-first team at Summit and their growing physician support around ivonescimab, our PD-1, VEGF, bispecific, and lead investigational asset.

我為 Summit 這支高度專注、使命導向、以病患為先的團隊感到非常自豪，也為醫師對 ivonescimab（我們的 PD-1/VEGF 雙特異性、且為主要研發中資產）的支持日益增加而感到振奮。

In addition, we continue to appreciate Big Pharma's high interest in ivonescimab as the backbone of combination therapy in many different solid-tumor settings.

此外，我們也持續感受到大型藥廠對 ivonescimab 的高度興趣，將其視為多種不同實體腫瘤情境中合併療法的骨幹。

As we look to successfully combine ivonescimab with their innovative new targets, our team continues to grow in number and ability, as we expand our clinical development plan and prepare for commercialization, in anticipation of a decision from the FDA on our BLA toward the end of this year.

隨著我們致力於將 ivonescimab 與他們創新的新靶點成功結合，我們的團隊在人數與能力上持續成長；同時，我們也在擴大臨床開發計畫並為商業化做準備，預期 FDA 將於今年年底前後就我們的 BLA 做出決定。

Before we start with key updates from the past couple of months, I'd like to take a moment to remind those of you who have been with us from the beginning and introduce to those of you who may be new to the story of what ivonescimab has accomplished, to date. You can see this on slide 3.

在我們開始回顧過去幾個月的重點更新之前，我想花一點時間，提醒一路以來與我們同行的各位，也向可能剛接觸我們故事的新朋友介紹：截至目前 ivonescimab 已取得的成果。各位可在第 3 張投影片看到。

Ivonescimab has read out four Phase 3 clinical studies, to date -- all four with positive data. This has led to two approvals in China, so far; with one, currently, under review.

截至目前，ivonescimab 已公布四項第 3 期臨床研究結果——四項皆為正向數據。這已促成目前在中國的兩項核准，另有一項正在審查中。

In addition to the pending BLA with the US FDA, a total of 15 Phase 3 trials are currently ongoing or have read out in multiple tumor types.

除向美國 FDA 提交且仍在審查中的 BLA 之外，目前共有 15 項第 3 期試驗正在進行或已在多種腫瘤類型中讀出結果。

Between Summit and our partners at Akeso, 52 clinical trials have been initiated, evaluating ivonescimab in a variety of solid tumors. When including investigator-initiated and collaborative studies, a total of 171 clinical trials are now listed on clinicaltrials.gov.

在 Summit 與我們的合作夥伴 Akeso 之間，已啟動 52 項臨床試驗，評估 ivonescimab 於多種實體腫瘤中的應用。若納入研究者發起與合作研究，目前在 clinicaltrials.gov 上登錄的臨床試驗總數已達 171 項。

The enthusiasm demonstrated by investigators around the world to generate data and sync positive signals for patients facing high-end medical need really speaks to the opportunity and ever-present optimism surrounding ivonescimab.

全球研究者展現的熱忱，致力於產出數據並為面臨高度未被滿足醫療需求的病患找出正向訊號，充分反映了 ivonescimab 所蘊含的機會，以及圍繞其始終存在的樂觀氛圍。

Together with Akeso, over 4,000 patients in either Summit-sponsored or Akeso-sponsored clinical trials across the world have been dosed with ivonescimab. Commercially, in China, over 70,000 patients have been administered ivonescimab.

Summit 與 Akeso 合作之下，全球在 Summit 或 Akeso 主導的臨床試驗中，已有超過 4,000 名病患接受 ivonescimab 給藥。在商業化方面，在中國已有超過 70,000 名病患使用 ivonescimab。

On slide 4, we see a snapshot of the current ivonescimab development plans across Summit and Akeso, as well as a Phase 3 clinical trial ,sponsored by prominent European cooperative group, GORTEC.

在第 4 張投影片中，我們可以看到 Summit 與 Akeso 目前的 ivonescimab 開發計畫概覽，以及由知名歐洲合作研究團體 GORTEC 主辦的一項第 3 期臨床試驗。

Our collective pipelines cover not only multiple settings in lung and colorectal cancers but, also, head and neck; breast; biliary, pancreatic; gynecological; gastric; and hepatocellular cancer, including non-metastatic settings.

我們的整體研發管線不僅涵蓋肺癌與大腸直腸癌的多種治療情境，也涵蓋頭頸癌、乳癌、膽道癌、胰臟癌、婦科癌、胃癌與肝細胞癌，並包含非轉移性情境。

Summit's announced Phase 3 studies focus on non-small cell lung cancer and colorectal cancer. These studies represent only a subset of ivonescimab's potential future indications, as you can see here.

Summit 已公布的第 3 期研究聚焦於非小細胞肺癌與大腸直腸癌。如各位在此所見，這些研究僅代表 ivonescimab 未來潛在適應症的一部分。

Through our wonderful partnership with Akeso, data generated in our studies, as well as data generated through investigator-sponsored trials, we continuously consider evolving ivonescimab to drive more informed, as well as faster, decisions, all of which support efficient and timely expansion of our global ivonescimab development plan.

透過我們與 Akeso 的良好合作關係，結合我們研究所產生的數據以及研究者主導試驗所產生的數據，我們持續評估並推進 ivonescimab 的演進，以做出更有依據且更快速的決策，進而支持我們全球 ivonescimab 開發計畫的高效率與及時擴展。

I'll now turn it over to Maky to discuss some of the recent developments. Maky?

接下來我把時間交給 Maky，請她談談近期的一些進展。Maky？

Thank you, Bob.

謝謝你，Bob。

Yesterday, we announced an updated OS analysis conducted for our global Phase 3 HARMONi trial. The HARMONi study evaluated ivonescimab plus chemo against chemo alone as a treatment for EGFR-mutated non-small cell lung cancer after TKI therapy, a patient population of significant unmet need, with few available treatment options.

昨天，我們公布了針對全球第 3 期 HARMONi 試驗所進行的更新整體存活期（OS）分析。HARMONi 研究評估 ivonescimab 合併化療相較於單獨化療，作為 EGFR 突變非小細胞肺癌病患在 TKI 治療後的治療選項；這是一個未被滿足需求顯著、可用治療選擇有限的族群。

In this most recent analysis, with a data cut-off in June 2026, Western patients increased their time on study, reaching a median follow-up of over 23 months. Asian patients remained locked, with a median follow-up time of 33 months.

在這次最新分析中（資料截止日為 2026 年 6 月），西方病患的研究追蹤時間增加，中位隨訪已超過 23 個月。亞洲病患資料仍維持鎖定，中位隨訪時間為 33 個月。

A hazard ratio of [0.76] was observed in both the total population, as well as the regional Western data. The hazard ratio for Western patients has improved, with more follow-up time.

在總體族群以及西方地區數據中，觀察到的風險比（hazard ratio）為 [0.76]。隨著隨訪時間增加，西方病患的風險比已有所改善。

With longer follow-up, results of Western patients are now consistent in terms of the magnitude of OS benefit with those patients enrolled in Asia, who had a longer follow-up at the time of their primary OS analysis.

在更長的隨訪下，西方病患的結果在 OS 獲益幅度方面，現已與亞洲入組病患一致；而亞洲病患在主要 OS 分析時的隨訪時間更長。

Ivonescimab continued to demonstrate an acceptable and manageable safety profile that was consistent with previous Phase 3 results of ivonescimab plus chemo. No additional safety signals were observed in this current HARMONi data cut compared to the previous data cuts.

Ivonescimab 持續展現可接受且可管理的安全性特徵，並與先前 ivonescimab 合併化療的第 3 期結果一致。與先前的資料截止相比，本次 HARMONi 資料截止未觀察到額外的安全性訊號。

As a reminder: This setting is one in which multiple PD-1 inhibitors have failed, previously, to show a benefit in either PFS or OS.

提醒各位：在此治療情境中，過去已有多種 PD-1 抑制劑未能在 PFS 或 OS 上顯示獲益。

Prior Phase 3 studies were conducted in this setting, individually, with pembro or nivo, each in combination with chemo and were not successful.

先前在此治療情境中分別以 pembro 或 nivo 各自合併化療所進行的第三期研究均未成功。

In addition, there are currently no approved agents in this setting which have demonstrated an overall survival benefit compared to chemo alone.

此外，目前在此治療情境中，尚無任何已核准藥物相較於單用化療證實具有整體存活期（OS）獲益。

The encouraging result from this long-term overall survival analysis continue to support the ability to translate the therapeutic profile of ivonescimab across the globe, including the efficacy potential of ivonescimab in Western patients from North America and Europe.

這項長期整體存活期分析所呈現的令人鼓舞結果，持續支持 ivonescimab 的治療特性具備全球推廣的可轉譯性，包括 ivonescimab 在北美與歐洲西方患者中的療效潛力。

This data shows a consistent favorable OS trend across geographies, as Western patients were followed for additional time on study.

這些數據顯示，隨著西方患者在研究中獲得更長時間的追蹤，各地區皆呈現一致且有利的 OS 趨勢。

With meaningful follow-up time in both regions, the magnitude of the OS benefit is consistent between patients enrolled in China and enrolled in Western countries, including the United States, in the HARMONi study.

在兩個地區皆有具意義的追蹤時間下，HARMONi 研究中於中國入組與於西方國家（包括美國）入組的患者，其 OS 獲益幅度一致。

We intend to provide exciting additional details from this new long-term analysis at a future medical meeting. We have also made these results available to the FDA.

我們計畫在未來的醫學會議上提供這項新的長期分析之更多令人振奮的細節。我們也已將這些結果提供給 FDA。

As previously disclosed, the FDA noted that a statistically significant overall survival benefit is necessary to support marketing authorization in this setting.

如先前揭露，FDA 指出在此治療情境中，需具統計顯著的整體存活期獲益，方能支持上市許可。

Considering the safety and efficacy profile of the current FDA-approved options for patients in this setting, none of which have demonstrated a statistically significant OS benefit, as well as the continued positive regionally consistent data of this Phase 3 multi-regional study; and discussions with key opinion leaders and physicians, who have administered ivonescimab to patients.

考量目前 FDA 已核准之此情境治療選項的安全性與療效特性（其中無一證實具統計顯著的 OS 獲益），以及這項第三期多區域研究持續呈現跨區域一致的正向數據；並結合與關鍵意見領袖及曾為患者施用 ivonescimab 的醫師之討論。

We believe that ivonescimab is a potential treatment option, with favorable benefit risk profile.

我們相信 ivonescimab 具備作為潛在治療選項的可能性，且其效益風險特性良好。

Turning, specifically, to Summit's global ivonescimab pipeline, which is noted on slide 7, we have four phase 3 trials completed or ongoing: HARMONi, which we just covered; HARMONi-3; HARMONi-7; and HARMONi-GI3.

接著，具體談到 Summit 的全球 ivonescimab 產品線（如投影片 7 所示），我們已有四項第三期試驗完成或正在進行：HARMONi（我們剛剛已說明）；HARMONi-3；HARMONi-7；以及 HARMONi-GI3。

HARMONi-3 is evaluating ivonescimab plus chemo against pembro plus chemo in first-line metastatic non-small cell lung cancer in both patients with squamous and non-squamous histologies, each of which will be analyzed separately.

HARMONi-3 正在評估 ivonescimab 合併化療，相較於 pembro 合併化療，作為一線治療用於轉移性非小細胞肺癌患者，涵蓋鱗狀與非鱗狀組織學類型，且兩者將分別進行分析。

These patient populations represent a significant unmet medical need, with the nearly 100,000 patients in the United States alone, as this trial covers first-line non-small cell lung cancer patients without genomic alterations.

這些患者族群代表顯著的未被滿足醫療需求；僅在美國就接近 100,000 名患者，因本試驗涵蓋未具有基因體變異的一線非小細胞肺癌患者。

In line with prior guidance, we have completed enrollment in both the squamous and non-squamous cohorts.

依照先前指引，我們已完成鱗狀與非鱗狀兩個隊列的入組。

We expect to reach the number of events needed to conduct a PFS analysis for the squamous cohort in the second half of this year, which would also come with a corresponding early interim look at overall survival.

我們預期將於今年下半年達到進行鱗狀隊列 PFS 分析所需的事件數，並同時進行相對應的整體存活期早期期中檢視。

We would expect to reach the number of events for the first look at OS that is independent of the PFS analysis in the first half of 2027.

我們預期在 2027 年上半年達到首次 OS 檢視所需的事件數，該檢視獨立於 PFS 分析。

For the non-squamous cohort, we expect to reach the number of events needed to conduct a progression-free survival analysis in the first half of 2027.

針對非鱗狀隊列，我們預期在 2027 年上半年達到進行無惡化存活期分析所需的事件數。

HARMONi-7 is evaluating ivonescimab monotherapy against pembro monotherapy as first-line treatment for patients with non-small cell lung cancer that has high PD-L1 expression levels.

HARMONi-7 正在評估 ivonescimab 單藥治療相較於 pembro 單藥治療，作為一線治療用於 PD-L1 高表現之非小細胞肺癌患者。

Enrollment continues to be strong. We look forward to providing additional updates on this trial in the near future.

入組持續強勁。我們期待在不久的將來提供此試驗的更多更新。

HARMONi-GI3 evaluates ivonescimab plus chemo compared to beva plus chemo as first-line therapy in patients with unresectable colorectal cancer.

HARMONi-GI3 評估 ivonescimab 合併化療，相較於 beva 合併化療，作為不可切除結直腸癌患者的一線治療。

Our decision to initiate this study was driven by encouraging Phase 2 data published at ESMO 2024 and supported by global Phase 2 data presented in Q2 of this year at ASCO 2026. We look forward to providing further updates, as this global Phase 3 colorectal cancer trial progresses.

我們啟動此研究的決策，係基於於 ESMO 2024 發表的令人鼓舞之第二期數據，並由今年第二季於 ASCO 2026 發表的全球第二期數據所支持。隨著這項全球第三期結直腸癌試驗推進，我們期待提供進一步更新。

In addition to our sponsored studies, the Phase 3 study, ILLUMINE, is currently enrolling in head and neck cancer through a European cooperative group, GORTEC.

除我們主導的研究外，第三期研究 ILLUMINE 目前正透過歐洲合作研究團體 GORTEC，在頭頸癌領域進行入組。

This is another multi-regional Phase 3 study that tests ivonescimab with and without an anti-CD47 agent head to head against pembro in an additional tumor setting from our historical work.

這是另一項多區域第三期研究，在我們過往研究所涵蓋之外的另一腫瘤治療情境中，測試 ivonescimab（合併或不合併抗 CD47 藥物）與 pembro 進行頭對頭比較。

The trial is enrolling in Europe; is intended to start in China later this year. We will evaluate opening sites in the US, based on continued progress.

該試驗正在歐洲入組；並預計於今年稍晚在中國啟動。我們將依據持續進展評估在美國開設試驗中心。

Additionally, we have over 65 ISTs that we intend to support in various stages of development. Of these, 24 are currently enrolling -- and more publication on being featured at each major medical conference -- often in prominent session -- at ASCO, ESMO, and World Conference on Lung Cancer.

此外，我們計畫支持超過 65 項處於不同開發階段的研究者發起試驗（IST）。其中有 24 項目前正在入組——並且在 ASCO、ESMO 及世界肺癌大會等各大醫學會議上，常於重要場次中有更多發表或被重點呈現。

Through this combined research, ivonescimab has now been featured in over 50 publications, presentations, and posters.

透過這些綜合研究，ivonescimab 迄今已出現在超過 50 篇論文、口頭報告與海報展示中。

Now, I would like to take a minute to focus on some of the clinical trial collaboration in which we have entered to evaluate ivonescimab with novel combinations.

現在，我想花一點時間聚焦於我們已建立的部分臨床試驗合作，以評估 ivonescimab 與新型組合療法的搭配。

Clinical development of ivonescimab in additional tumor settings also continues to progress as planned via our collaborations with RevMed; GSK; and, now, with Arcus.

透過我們與 RevMed、GSK，以及現在與 Arcus 的合作，ivonescimab 在其他腫瘤治療情境中的臨床開發也持續按計畫推進。

With respect to novel-novel combinations, our collaboration with Revolution Medicines began enrolling in the first quarter of this year. This collaboration evaluates ivonescimab in combination with three novel RAS inhibitors across multiple solid-tumor settings, including pancreatic, colorectal, and non-small cell lung cancers.

就「新藥對新藥」的組合而言，我們與 Revolution Medicines 的合作已於今年第一季開始入組。此合作評估 ivonescimab 與三種新型 RAS 抑制劑的合併使用，涵蓋多種實體腫瘤情境，包括胰臟癌、結直腸癌與非小細胞肺癌。

We are enthusiastic about the opportunity of ivonescimab with multiple existing RAS inhibitors and what the combination has the potential to do for patients facing difficult-to-treat cancers.

我們對 ivonescimab 與多種既有 RAS 抑制劑併用的機會感到振奮，並看好此組合對面臨難治癌症患者可能帶來的潛在效益。

Our GSK collaboration evaluating ivonescimab in multiple solid-tumor settings in combination with their B7-H3 ADC is expected to enroll its first patient later this quarter.

我們與 GSK 的合作，評估 ivonescimab 與其 B7-H3 ADC 於多種實體腫瘤情境中的合併使用，預計將於本季稍晚納入首位患者。

This is another example of promising targets seeking to significantly advance outcomes in settings, such as multiple types of lung cancer and colorectal cancer, where both ivonescimab and B7-H3 ADCs have shown promise.

這是另一個例子，顯示具前景的標的正尋求在多種肺癌與結直腸癌等治療情境中顯著改善療效；在這些領域中，ivonescimab 與 B7-H3 ADC 均已展現潛力。

We are also pleased to announce, yesterday, that we have established a collaboration with Arcus Biosciences to evaluate ivonescimab in combination with Arcus HIF-2α inhibitor, casdatifan, in first-line metastatic clear cell renal cell carcinoma, the most common form of kidney cancer.

我們也很高興宣布，於昨日我們已與 Arcus Biosciences 建立合作，評估 ivonescimab 與 Arcus 的 HIF-2α 抑制劑 casdatifan 合併使用，作為一線治療用於轉移性透明細胞腎細胞癌（最常見的腎癌類型）。

This combination presents a compelling opportunity for a potentially well-tolerated TKI-sparing option to prolong survival in this setting. We expect initial data from this collaboration to be generated by mid-next year.

此組合在該治療情境中提供一個具吸引力的機會，可能成為耐受性良好、可避免使用 TKI 的選項，以延長存活期。我們預期此合作的初步數據將於明年年中產出。

Collectively, these trials enhance and inform our own clinical development activities, as we learn more about new settings, where neither we nor Akeso have yet had the opportunity to explore.

整體而言，這些試驗強化並為我們自身的臨床開發活動提供資訊，因為我們得以進一步了解新的治療情境，而這些情境過去我們與 Akeso 均尚未有機會探索。

Additionally, the continued enthusiastic interest in ISTs is a testament for the optimism we have heard from many investigators, as they consider the potential opportunity that ivonescimab presents across multiple tumor types and in multiple novel-novel combinations, regimens.

此外，對 IST 持續高漲的熱忱也證明了我們從許多研究者所聽到的樂觀態度，因他們正評估 ivonescimab 在多種腫瘤類型以及多種新藥對新藥組合與治療方案中的潛在機會。

Now, let's take a closer look at the clinical data we have seen from ivonescimab today, focusing on OS results.

現在，讓我們更仔細檢視我們迄今從 ivonescimab 所看到的臨床數據，並聚焦於 OS 結果。

Of the four Phase 3 studies that have read out, to date, all four studies had positive, statistically significant, clinically meaningful progression-free survival results.

截至目前已讀出結果的四項第三期研究中，四項研究皆取得正向、具統計顯著且具臨床意義的無惡化存活期（PFS）結果。

In each of these studies, ivonescimab has achieved overall survival hazard ratios less than the generally accepted clinical meaningfulness threshold of [0.80].

在上述每一項研究中，ivonescimab 的整體存活期風險比（HR）皆低於一般公認具臨床意義的門檻[0.80]。

We discussed the updated data from the global HARMONi study earlier. We look forward to presenting additional details, such as Kaplan-Meier curves, medians, and other important components of the analysis at an upcoming medical conference.

我們先前已討論全球 HARMONi 研究的更新數據。我們期待在即將舉行的醫學會議上呈現更多細節，例如 Kaplan-Meier 曲線、中位數以及分析中的其他重要組成部分。

While not achieving statistical significance at the primary OS analysis, the nominal P-value implies significance of the OS benefit for the global study. This is further supported by the updated OS data announced yesterday.

儘管在主要 OS 分析中未達統計顯著性，但名目 P 值顯示全球研究的 OS 獲益具有顯著性。昨日公布的更新 OS 數據亦進一步支持此點。

The HARMONi-A study in China, in a similar setting to HARMONi, produced consistent results and demonstrated a statistically significant benefit in OS.

中國的 HARMONi-A 研究在與 HARMONi 類似的情境下，產生一致結果，並顯示 OS 具有統計顯著的獲益。

HARMONi-2, conducted in China, which was the first time a Phase 3 clinical trial has shown a statistically significant improvement in progression-free survival, directly replaced a PD-1 inhibitor in head-to-head setting, reported an overall survival hazard ratio of [0.78] at just 39% data maturity.

在中國進行的 HARMONi-2，是首次有第 3 期臨床試驗在頭對頭比較中直接取代 PD-1 抑制劑，並顯示無惡化存活期具有統計顯著改善；在僅 39% 數據成熟度時，即報告整體存活期風險比為 [0.78]。

This study evaluated ivonescimab monotherapy against pembro monotherapy as front-line treatment for patients with non-small cell lung cancer, whose tumors have positive PD-L1 expression, a similar patient population to Summit global Phase 3 HARMONi-7 study, which focuses on tumors with high PD-L1 expression.

本研究評估 ivonescimab 單藥相較於 pembro 單藥，作為 PD-L1 表達陽性的非小細胞肺癌患者一線治療；其患者族群與 Summit 全球第 3 期 HARMONi-7 研究相近，後者聚焦於 PD-L1 高表達腫瘤。

Finally, the HARMONi-6 study conducted in China achieved an overall survival hazard ratio of [0.68], as announced at the plenary session of ASCO 2026.

最後，中國進行的 HARMONi-6 研究達成整體存活期風險比 [0.68]，並已於 ASCO 2026 全體大會（plenary session）公布。

The magnitude of benefit measured by the hazard ratio for OS was consistent with the benefit for PFS, both with hazard ratios in the 0.6.

以 OS 風險比衡量的獲益幅度與 PFS 的獲益一致，兩者的風險比皆落在 0.6 的範圍。

Again, this study compared ivonescimab with chemo against an anti-PD-1 plus chemo as front-line treatment for patients with non-small cell lung cancer of squamous histology.

同樣地，本研究比較 ivonescimab 合併化療，與抗 PD-1 合併化療，作為鱗狀組織學非小細胞肺癌患者的一線治療。

This is the first time a Phase 3 clinical trial in any tumor type, not just in non-small cell lung cancer, has shown a statistically significant improvement in overall survival compared to a PD-1 inhibitor in combination with chemo in head-to-head setting.

這是首次在任何腫瘤類型（不僅限於非小細胞肺癌）的第 3 期臨床試驗中，在頭對頭比較下，相較於 PD-1 抑制劑合併化療，顯示整體存活期具有統計顯著改善。

Four Phase 3 studies have been conducted in three different non-small cell lung cancer settings, all producing clinically meaningful overall survival hazard ratios under 0.80.

已在三種不同的非小細胞肺癌治療情境中完成四項第 3 期研究，皆產生具臨床意義且低於 0.80 的整體存活期風險比。

Two of the four studies were conducted head-to-head against a PD-1 inhibitor, with or without chemotherapy. Two were conducted in settings where PD-1 inhibitors are not approved because they failed in past Phase 3 clinical studies.

四項研究中有兩項為與 PD-1 抑制劑進行頭對頭比較，包含或不包含化療。另兩項則是在 PD-1 抑制劑未獲核准的情境中進行，原因是其在過去第 3 期臨床研究中失敗。

These results speak to the opportunity to replace current immunotherapy options with ivo, the potential next generation of cancer therapy.

這些結果凸顯以 ivo 取代現行免疫治療選項的機會，ivo 可能成為下一代癌症治療。

As we have said before, we feel the data speaks for themselves and support immense potential for ivonescimab to help patients with lung cancer and we believe in additional tumor settings, as well, as more data is generated and accumulates across Summit and Akeso trials, ISTs, and collaborations.

如同我們先前所述，我們認為數據本身已充分說明，並支持 ivonescimab 在協助肺癌患者方面具有巨大的潛力；且隨著更多數據在 Summit 與 Akeso 的試驗、研究者發起試驗（ISTs）及合作中持續產生與累積，我們也相信其在其他腫瘤治療情境同樣具潛力。

Turning to slide 9 and looking to the existing next steps for ivonescimab, our global Phase 3 HARMONi-3 all-comers trial evaluating ivonescimab with chemo in front-line non-small cell lung cancer has completed enrollment in both the squamous and non-squamous cohorts.

接著看第 9 張投影片並聚焦 ivonescimab 既有的下一步，我們的全球第 3 期 HARMONi-3 全人群（all-comers）試驗，評估 ivonescimab 合併化療作為一線非小細胞肺癌治療，已在鱗狀與非鱗狀兩個隊列完成收案。

We expect to reach the number of event for the primary PFS analysis for the squamous cohort in the second half of this year, which would come with a corresponding interim look at overall survival.

我們預期今年下半年將達到鱗狀隊列主要 PFS 分析所需的事件數，並將同步進行整體存活期的期中分析。

Importantly, we expect to have another interim look at OS in first half of 2027, which will have additional follow-up time, something we continue to note as an important factor in showing the value of ivonescimab in these clinical studies.

重要的是，我們預期在 2027 年上半年將再進行一次 OS 期中分析，屆時將有更長的追蹤時間；我們持續強調，這是展現 ivonescimab 在這些臨床研究中價值的重要因素。

For the non-squamous cohort, we expect to reach the number of events for the PFS analysis in the first half of 2027.

就非鱗狀隊列而言，我們預期在 2027 年上半年達到 PFS 分析所需的事件數。

Turning to our BLA filing, based on our Phase 3 HARMONi study, seeking approval for ivonescimab plus chemo in the EGFR-mutated non-small cell lung cancer setting, post-TKI therapy, the submission is currently under review with the US. FDA. The agency has provided a target PDUFA date of November 14 of this year.

接著談我們的 BLA 申請：基於第 3 期 HARMONi 研究，我們正尋求 ivonescimab 合併化療在 EGFR 突變非小細胞肺癌、TKI 治療後情境的核准；目前該申請正在美國FDA審查中。主管機關已提供今年 11 月 14 日的目標 PDUFA 日期。

We continue to grow our commercial capabilities, as we prepare in anticipation of ivonescimab's potential first US approval and potential launch later this year.

我們持續強化商業化能力，為 ivonescimab 可能取得首個美國核准並於今年稍晚可能上市做準備。

We will continue to provide further details on additional new global studies throughout the year, as they are ready to share. To date, we have initiated global Phase 3 studies in non-small cell lung cancer, colorectal cancer through our partnership with GORTEC's head and neck squamous cell carcinoma.

我們將在全年持續提供更多新增全球研究的進一步細節，待準備好即可分享。截至目前，我們已啟動非小細胞肺癌與結直腸癌的全球第 3 期研究，並透過與 GORTEC 的合作推進頭頸部鱗狀細胞癌。

We look forward to continuing to grow our global pipeline, explore ivonescimab's potential to help additional patients in new tumor types and settings in the near future.

我們期待持續擴大全球研發管線，並在不久的將來探索 ivonescimab 在新的腫瘤類型與治療情境中協助更多患者的潛力。

On today's call, we have covered ivonescimab's recent accomplishments in the clinic but, as a reminder, this is only the beginning of a vast potential market opportunity for ivonescimab across solid tumors.

在今天的電話會議中，我們已涵蓋 ivonescimab 近期在臨床上的成果；但提醒各位，這僅是 ivonescimab 在各類實體腫瘤中龐大市場機會的開端。

We have discussed this previously but, with each successful data set, it becomes closer to reality. Ivonescimab has the potential to be a platform blockbuster drug.

我們先前已討論過這點，但隨著每一組成功的數據出爐，這個願景就更接近實現。Ivonescimab 有潛力成為平台型重磅藥物（platform blockbuster）。

Ivonescimab is well-positioned to make a significant impact across the solid-tumor treatment landscape between checkpoint inhibitors and anti-VEGF therapies. The estimated total addressable market is in excess of $100 billion, globally.

Ivonescimab 具備良好定位，可在檢查點抑制劑與抗 VEGF 治療之間，對實體腫瘤治療版圖產生重大影響。估計的全球總可服務市場（TAM）超過 1,000 億美元。

Looking only at the checkpoint inhibitor market for non-small cell lung cancer, in which our first set of registrational Phase 3 studies are conducted, market estimates for immunotherapy, itself, are expected to exceed $20 billion per year by 2028.

若僅看非小細胞肺癌的檢查點抑制劑市場（亦即我們首批註冊性第 3 期研究所處領域），市場預估顯示免疫治療本身到 2028 年每年可望超過 200 億美元。

On slide 10, we identify the more than 50 solid-tumor settings where anti-PD-1, anti-VEGF therapies are approved: established PD-1 and PD-L1 indications in green and anti-VEGF indication in purple.

在第 10 張投影片中，我們辨識出超過 50 個已核准抗 PD-1、抗 VEGF 治療的實體腫瘤治療情境：綠色為既有 PD-1 與 PD-L1 適應症，紫色為抗 VEGF 適應症。

The settings highlighted in yellow represent the indications we are currently running global Phase 3 trials for ivonescimab: lung and colorectal cancers.

以黃色標示的情境代表我們目前正在進行 ivonescimab 全球第 3 期試驗的適應症：肺癌與結直腸癌。

Clearly, there are several additional opportunities for ivonescimab beyond, today, PD-1 or VEGF landscape, including novel settings, such as EGFR-mutant lung cancer. We intend to provide details regarding additional studies, including Phase 3 studies, in the near term.

顯然，除目前的 PD-1 或 VEGF 治療版圖之外，ivonescimab 尚有多項額外機會，包括新的治療情境，例如 EGFR 突變肺癌。我們計畫在近期提供更多研究（包含第 3 期研究）的細節。

Ivonescimab differentiated profile, as we saw with HARMONi-6, achieving a statistically significant, highly clinically meaningful progression-free survival and overall survival benefit, alongside the updated global HARMONi data, support its platform potential across multiple indication, many of which could be blockbuster opportunities on their own.

Ivonescimab 的差異化特徵——如同我們在 HARMONi-6 所見，達成具統計顯著且高度具臨床意義的無惡化存活期與整體存活期獲益——再加上全球 HARMONi 更新數據，支持其作為平台型產品在多項適應症上的潛力，其中許多單獨就可能是重磅機會。

We have only just begun to see the potential of ivonescimab to help patients with solid tumors. These are exciting times at Summit. We encourage you to follow our journey closely, as we continue to expand the ivonescimab's clinical-development plan in a new tumor setting.

我們才剛開始看到 ivonescimab 協助實體腫瘤患者的潛力。這是 Summit 令人振奮的時刻。我們鼓勵各位密切關注我們的進展，因為我們將持續在新的腫瘤治療情境中擴展 ivonescimab 的臨床開發計畫。

Now, I will turn the call over to Manmeet to provide a financial update. Manmeet?

現在，我將把電話會議交給 Manmeet，請他提供財務更新。Manmeet？

Thank you, Maky. Good afternoon, everyone.

謝謝你，Maky。各位下午好。

On the financials front, let me start with our cash position. We ended the second quarter of 2026 with a strong cash position of approximately $690.7 million, as compared to $598.7 million at the end of first quarter of 2026.

在財務方面，我先從我們的現金部位談起。我們在 2026 年第二季末的現金部位強勁，約為 6.907 億美元，相較於 2026 年第一季末的 5.987 億美元。

This increase of $92 million in cash position for the quarter is primarily due to the $231 million cash raised from our ATM facility, offset by the cash used in our operating activities of approximately $140 million for the second quarter of 2026.

本季現金部位增加9,200萬美元，主要來自我們透過ATM融資機制籌得的2.31億美元現金，並被我們在2026年第二季營運活動使用的約1.40億美元現金所抵銷。

Consistent with our financing strategy in the past, earlier today, we also filed a prospectus supplement for a new ATM facility, up to $380 million, to provide us with additional flexibility for financing, both with respect to mechanism and timing.

延續我們過去一貫的融資策略，我們今天稍早也就一項新的ATM融資機制提交了增補招股說明書，額度最高達3.80億美元，以在融資機制與時點兩方面為我們提供更大的彈性。

Finally, to remind everyone, currently, we have no debt on our balance sheet.

最後提醒大家，目前我們的資產負債表上沒有任何負債。

Turning to operating expenses, I will provide details on both GAAP and non-GAAP numbers. You can refer to our press release issued earlier today for a reconciliation of GAAP to non-GAAP financial measures.

接著談營運費用，我將同時提供GAAP與非GAAP數字的細節。各位可參考我們今天稍早發布的新聞稿，其中包含GAAP與非GAAP財務衡量指標之間的調節表。

As a reminder: Non-GAAP expenses exclude stock-based compensation expense.

提醒一下：非GAAP費用不包含以股份為基礎的薪酬費用。

Total GAAP operating expenses for the second quarter of 2026 were $220.5 million compared to $195.2 million for the first quarter of 2026.

2026年第二季GAAP營運費用總額為2.205億美元，相較之下，2026年第一季為1.952億美元。

The increase in GAAP operating expense was primarily due to an increase in our R&D expenses related to clinical trial expenses for HARMONi-GI3, HARMONi-3, and HARMONi-7.

GAAP營運費用的增加主要是因為研發費用上升，與HARMONi-GI3、HARMONi-3及HARMONi-7的臨床試驗費用相關。

Overall, our non-GAAP operating expenses during the second quarter of 2026 were $151.8 million compared to $122.4 million for the first quarter of 2026.

整體而言，我們2026年第二季的非GAAP營運費用為1.518億美元，相較之下，2026年第一季為1.224億美元。

This increase in non-GAAP operating expenses was primarily related to an increase in R&D expenses, as previously mentioned.

非GAAP營運費用的增加主要與研發費用上升有關，如先前所提。

With that, I will turn the call back over to Dave. Dave?

接下來我把電話交回給Dave。Dave？

Thank you, Manmeet.

謝謝你，Manmeet。

We will now see if there are any questions. Operator, if you could please open the line for those questions?

我們現在看看是否有任何問題。接線員，麻煩您為提問者開放線路，好嗎？

We will now begin the question-and-answer session.

我們現在開始問答環節。

(Operator Instructions)

(接線員指示)

Yigal Nochomovitz, Citigroup.

Yigal Nochomovitz，花旗集團。

Hi. Great. Thank you very much for taking the questions.

嗨。很好。非常感謝讓我提問。

Very interesting recent updated overall survival cut from the second-line EGFR study. I am wondering if you could speak to the translatability of that conclusion, in terms of equivalence on OS, across geographies, when thinking about some of the other larger markets; specifically, of course, front-line non-small cell lung cancer.

近期第二線EGFR研究更新的整體存活期（OS）切點非常有意思。我想請教的是，當我們思考其他更大的市場、特別是第一線非小細胞肺癌時，您能否談談這個結論在不同地理區域之間的可轉譯性，也就是OS等效性的問題？

Could you talk about how you think those OS results could translate to those other settings, please? Thank you.

能否談談您認為這些OS結果如何能轉譯到其他情境？謝謝。

Sure. Thanks, Yigal. Appreciate the question. This is Dave.

當然可以。謝謝你，Yigal。感謝這個問題。我是Dave。

I think, in terms of take-aways and learnings, right, maturity in follow-up time is critical, in particular, for ivonescimab as a next-generation immunotherapy.

我認為，就重點與學習而言，對於ivonescimab這類次世代免疫療法，追蹤時間的成熟度至關重要。

And so, as we think about the translatability, what we saw is, with meaningful follow-up time, there was consistent magnitude of benefit of overall survival.

因此，當我們思考可轉譯性時，我們看到的是：在具意義的追蹤時間下，整體存活期的受益幅度是一致的。

That's particularly important, when we think about the difference between what we saw at the primary analysis in HARMONi versus what we saw published yesterday.

這點特別重要，因為我們要比較在HARMONi主要分析時看到的結果，與昨天發表的結果之間的差異。

But then, when we take that to the other front-line studies, we have an opportunity, now, to show a magnitude of benefit that is clinically meaningful in those studies, as well, with the appropriate follow-up time, specifically, for overall survival.

而當我們把這點延伸到其他第一線研究時，只要有適當的追蹤時間、特別是針對整體存活期，我們現在也有機會在那些研究中展現臨床上具意義的受益幅度。

And so, if you recall, HARMONi-6 had an overall survival median follow-up or a median follow-up time, rather, of 21 months in its overall survival analysis.

因此，如果各位還記得，HARMONi-6在其整體存活期分析中的OS中位追蹤期（或更精確地說，中位追蹤時間）為21個月。

And then, the recent data that we published yesterday for HARMONi, the Western patients now have 23 months, approximately, of median follow-up time.

而我們昨天發布的最新HARMONi數據中，西方患者目前約有23個月的中位追蹤時間。

And so, as we look at what that means, overall, it's important, globally, to have consistent follow-up time that's meaningful across both so -- that not necessarily equal to each other but meaningful for all regions.

因此，從整體來看，重要的是在全球範圍內，讓追蹤時間在各地區都具有意義且一致——不一定要彼此完全相同，但對所有地區都要有意義。

And so we expect the ability to translate clinically meaningful results in China to clinically meaningful results across the globe, with meaningful follow-up time.

因此，我們預期，只要有具意義的追蹤時間，就能把在中國得到的臨床上具意義的結果，轉譯為全球各地同樣臨床上具意義的結果。

Okay. Thanks. Just one quick follow-up, if I may, on HARMONi-3: Can you provide any more granularity on the timing within the second half of this year for the final PFS?

好的。謝謝。如果可以的話，我再追問一個關於HARMONi-3的問題：您能否更具體說明今年下半年最終PFS的時間點？

And then, with the early interim OS look, is this going to be, like, a qualitative comment? Or are you going to be able to, perhaps, give a very early hazard ratio? If you could speak to that, please.

另外，針對早期的OS期中分析，這會只是定性評論嗎？或者您可能可以提供非常早期的風險比（hazard ratio）？麻煩您談談。

Yeah. Absolutely. I think, with respect to timing, as we enter the second half of 2026, we have a little bit of a clearer view on event rates and are providing more precise language, with respect to expectations here for disclosures.

可以。當然。我想就時間點而言，隨著我們進入2026年下半年，我們對事件發生率有更清楚的掌握，因此在揭露預期方面提供了更精確的措辭。

In general, event rates have slowed down a little bit. And so we still expect to reach the number of events needed for the PFS analysis in the second half of this year.

整體而言，事件發生率稍微放緩了一些。因此，我們仍預期會在今年下半年達到進行PFS分析所需的事件數。

That timing is not next month. It is going to be likely towards the middle to back end of 2026. That's why we're a little bit more precise within the press release, itself.

但那個時間點不是下個月。更可能會落在2026年中段到後段。這也是為什麼我們在新聞稿中本身用語更精確一些。

With respect to the actual disclosure, itself, I don't know that we have a specific disclosure plan set. But I think what we would expect is a directional trend from that data but, again, not necessarily a determined disclosure plan.

至於實際揭露內容本身，我不確定我們是否已制定特定的揭露計畫。但我認為我們預期會從數據中看到方向性的趨勢，不過同樣地，目前未必有既定的揭露計畫。

But what we do expect is an ability to meaningfully take away the opportunity of what overall survival will show in this study.

但我們確實預期，屆時能夠有意義地解讀本研究在整體存活期方面將呈現的機會與訊息。

Again, recall the fact that, with 22, 23 months of overall survival or follow-up time in an overall survival analysis, we've shown meaningful data in HARMONi-6 in China. And then, the global HARMONi data -- the Western patients -- with meaningful follow-up time showed that benefit.

再次提醒，當OS分析的整體存活期或追蹤時間達到22、23個月時，我們已在中國的HARMONi-6中展示了具意義的數據。而全球HARMONi數據——西方患者——在具意義的追蹤時間下也顯示了該項受益。

And so the follow-up time will be important there to get a full, clear picture. But we do expect to see an overall survival trend that is meaningful to us, when we look at it later on.

因此，追蹤時間對於取得完整且清晰的全貌會很重要。但我們確實預期，之後回頭看時，會看到對我們而言具意義的整體存活期趨勢。

Great. Thank you.

很好。謝謝。

Tyler Van Buren, TD Cowen.

Tyler Van Buren，TD Cowen。

Great. Thanks very much. This is [Nick], on for Tyler.

很好。非常感謝。我是[Nick]，代替Tyler提問。

With the HARMONi-3 survival analysis -- the interim survival analysis -- in the first half of next year, will we get an overall survival hazard ratio, potentially, at this point? If so, what will be the median follow-up, as we think about what the bar should be and how it could progress, over time, just like we saw with the Western population in the HARMONi trial?

關於HARMONi-3的存活分析——期中存活分析——在明年上半年時，我們是否有可能在那個時間點拿到整體存活期的風險比？如果可以，當我們思考門檻應該如何設定，以及它如何會隨時間推進、就像我們在HARMONi試驗的西方族群所看到的那樣，中位追蹤期會是多少？

Thanks.

謝謝。

Yeah. That's a fair question, Nick. Appreciate it.

是的。這是個合理的問題，Nick。感謝。

I think, with respect to the additional overall survival interim analysis looked at in the first half of 2027, that gets closer to the median follow-up times that we saw with the HARMONi-6 OS analysis, as well as the western patients that we disclosed yesterday.

我想，關於2027年上半年進行的額外整體存活期期中分析，其時間點會更接近我們在HARMONi-6的OS分析中看到的中位追蹤期，以及我們昨天揭露的西方患者所呈現的中位追蹤期。

And so I think that piece, in particular, when we look at the first-half 2027, that's really the first analysis that is independent of any pre-planned PFS analysis.

因此我認為那一部分，特別是當我們看2027年上半年時，那確實是第一個不受任何預先規劃的PFS分析影響的獨立分析。

And so that's why it was important, we felt, to call that out, specifically, in Maky's prepared remarks, as well as our press release.

因此這就是為什麼我們認為有必要在Maky的事先準備發言以及我們的新聞稿中特別點出這一點。

That additional OS analysis, we used that first (inaudible) -- analysis that's not directly linked to a PFS analysis.

那個額外的OS分析，我們使用了那個第一個（聽不清）——也就是不直接連結到PFS分析的分析。

But, from a follow-up time perspective, we would expect that to be in the first half of 2027 -- the median, followed -- to be consistent with what we saw for HARMONi-6, as well as for the HARMONi Western data that we talked about yesterday.

不過，從隨訪時間的角度來看，我們預期那會在2027年上半年——中位數隨訪——與我們在HARMONi-6所看到的，以及我們昨天談到的HARMONi西方數據所見一致。

Very good. Thanks.

非常好。謝謝。

Salveen Richter, Goldman Sachs.

Salveen Richter，高盛。

Thank you. Good afternoon.

謝謝。下午好。

Just following up with the last questions; just given the split of the study into separate squamous and non-squamous cohorts and that enrollment was, overall, back-end loaded, how do we think about the level of follow-up in the context of the interim OS read-out?

延續上一個問題；鑑於研究被拆分為鱗狀與非鱗狀兩個獨立隊列，且整體入組在後期較為集中，我們應如何在期中OS讀出（interim OS read-out）的背景下看待隨訪程度？

If statistical significance is not seen at the interim, in your view, what level of OS benefit would support or trend, here, would support a statistically significant final OS result?

如果在期中分析未看到統計顯著性，依您看，什麼程度的OS獲益或趨勢，會支持最終OS結果達到統計顯著？

Yeah. Thanks, Salveen, for the question. I want to just clarify a couple of points:

是的。謝謝你的問題，Salveen。我想先澄清幾點：

We'll hit the number of events or we expect to hit the number of events for a PFS analysis sometime in the second half of this year. That will be accompanied by a supporting OS analysis. That would be an interim.

我們將在今年下半年某個時間點達到（或預期達到）進行PFS分析所需的事件數。那將伴隨一個支持性的OS分析。那會是一個期中分析。

And then, in the first half of 2027, that would also be an interim OS analysis. The final OS, as would be consistent with front-line studies, would be a ways out.

接著在2027年上半年，也會有一個期中OS分析。最終OS，如同一線研究的慣例，會在更久之後才會出來。

But what I would expect that we see, when we look at the analysis in the second half of this year, would be one that supports the curve-splitting for survival so a beginning look at overall survival that we would expect, if we look and we compare, when the curves split for HARMONi 6.

但我預期我們在今年下半年的分析中會看到的是：它能支持生存曲線的分離（curve-splitting），也就是對總生存的一個初步觀察；我們會期待看到類似於HARMONi 6中曲線開始分離時的那種比較結果。

That's a good indication in terms of what we would be looking to see. But that'll be early. That's really supportive of PFS.

這在我們想要看到的內容上是一個很好的指標。但那會是很早期的。它主要是對PFS的支持性證據。

As we look at -- many trials, when they run a primary PFS analysis, have a supporting OS look. When we look in the first half of 2027, that, now, has median follow-up time consistent with what we saw, again, in the HARMONi analysis for Western patients that we talked about yesterday.

我們看到——許多試驗在進行主要PFS分析時，都會同時做一個支持性的OS觀察。當我們看2027年上半年時，那時的中位隨訪時間將與我們昨天談到的、HARMONi分析中西方患者所見的情況一致。

And so, when we look at HARMONi-3 squamous in the first half of 2027, that's really a powered look at OS, from an interim-analysis perspective.

因此，當我們在2027年上半年看HARMONi-3鱗狀隊列時，從期中分析的角度來看，那其實是一個對OS具備檢定力（powered）的觀察。

We're not going to give specific thresholds, per se, because I think that it's a totality of what the curve looks like, number of events, maturity, so on and so forth.

我們不會給出具體門檻，因為我認為這取決於曲線整體的樣貌、事件數、成熟度等等。

But that Q1 or first half, rather, 2027 look, that really would be that, independent of PFS, powered interim look at OS.

但那個2027年第一季或更準確地說上半年的觀察，將會是那種——獨立於PFS之外——對OS具備檢定力的期中觀察。

Thank you.

謝謝。

Brad Canino, Guggenheim.

Brad Canino，Guggenheim。

Hi. Thanks for the updates.

嗨。謝謝更新。

Question from me is around the regional enrollment in H3. I'm wondering if that was done in parallel or if that was staggered because I'm thinking about this from the perspective of making sure the subgroups at an early interim OS analysis aren't skewed by, say, the North American patients coming in later than the China patients and not having time to see the effect, like, actually happen in the HARMONi study.

我的問題是關於H3的區域入組。我想知道這是同步進行，還是分階段推進；因為我在想，從確保早期期中OS分析的各亞組不會被扭曲的角度來看——例如北美患者比中國患者更晚入組，導致沒有足夠時間看到療效真正發生，就像在HARMONi研究中那樣。

Thanks.

謝謝。

Thanks for the question, Brad.

謝謝你的問題，Brad。

I think we've talked a little bit about the fact that the enrollment started together, generally speaking. But, obviously, enrollment in China is more rapid than it is in Western countries.

我想我們之前提過，整體而言入組是同時開始的。但很明顯，中國的入組速度比西方國家更快。

There's certainly a little bit of data that you see that involves Chinese enrollment a little bit faster, which is typical of what you would see in many studies.

你確實會看到一些數據顯示中國入組稍微更快，這也是許多研究中常見的情況。

I think, when we look at the timing of the events, part of what we take away from the learnings from HARMONi and whatnot is to make sure we have sufficient events that have taken place across the globe.

我認為，當我們看事件發生的時間點時，我們從HARMONi等研究的經驗中得到的一部分重點，是要確保全球各地都有足夠的事件發生。

And so it's not sequential timing, to the extent that HARMONi is, by any stretch. But, of course, it becomes important to have sufficient events across the study, with respect to those events.

因此它並不是像HARMONi那樣在時間上呈現序列式（sequential）的推進——完全不是那個程度。但當然，針對這些事件而言，確保整個研究中有足夠的事件數仍然很重要。

That's contemplated within our approach plan. I'll let Allen add some comments, as well.

這些都已納入我們的方法與計畫之中。我也請Allen補充一些評論。

Yeah. I'm going to add, Brad, to this. This is Allen. Brad, good question.

好的。我來補充一下，Brad。我是Allen。Brad，這是個好問題。

Just commenting on some of the previous questions: I just want to remind everyone that HARMONi-3 was our global study. It was started, globally, at the same time.

就前面一些問題再補充：我想提醒大家，HARMONi-3是我們的全球性研究。它是在全球同一時間啟動的。

There are some differences. Certain regions open very quickly and enroll very quickly. Other areas, there's more administrative burden, like Europe, to get the ethics committee review to open.

確實存在一些差異。某些地區開站很快、入組也很快。其他地區則有較多行政負擔，例如歐洲需要倫理委員會審查才能開站。

In the squamous study population, that is more prevalent in China. You'll see more aggressive enrollment.

在鱗狀研究人群中，這種疾病在中國更常見。你會看到更積極的入組。

However, I think people are asking about the non-squamous cohorts. Remember, we added that cohort after the study was ongoing. The sites were mostly open across the globe.

不過，我認為大家問的是非鱗狀隊列。請記得，我們是在研究進行中才新增那個隊列。當時全球大多數研究中心都已經開站。

In addition, that disease is more prevalent in the West. It's probably two-thirds of non-small cell lung cancer outside of China; whereas, in China, it's the other way around with the squamous.

此外，該疾病在西方更常見。在中國以外，它大概占非小細胞肺癌的三分之二；而在中國則相反，鱗狀更多。

And so, therefore, enrollment was actually very brisk in the West. And so we don't expect to see those differences.

因此，西方的入組其實非常迅速。所以我們不預期會看到那些差異。

All right. Thank you.

好的。謝謝。

Sure.

不客氣。

Mohit Bansal, Wells Fargo.

Mohit Bansal，富國銀行。

Hi. This is [Will Vang], on for Mohit Bansal. Thanks for taking our question.

嗨。我是[Will Vang]，代Mohit Bansal提問。謝謝讓我們提問。

Just following up on HARMONi-3, I know you guys previously expanded the enrollment for the trial to include both squam and non-squam but, also, the total size of the trial to push up some of these PFS and OS analysis timelines.

延續HARMONi-3的問題：我知道你們之前擴大了試驗入組，納入鱗狀與非鱗狀，同時也擴大了試驗總規模，以推進一些PFS與OS分析的時間線。

Just want to understand, how are you guys thinking about, one, the risk of a higher proportion of these PFS and OS events coming from early progressors or early OS event patients; and then, two, just how you're thinking about what the medium follow-up time will look like at the first-half interim OS for squam?

我想了解：第一，你們如何看待PFS與OS事件中有較高比例來自早期進展者或早期OS事件患者的風險；第二，你們如何看待在鱗狀隊列2027年上半年第一次期中OS時的中位隨訪時間會是什麼樣子？

Yeah. The last question, I think, is probably the easier of the two, in the sense of, when we get to the first half of 2027, we would expect median follow-up time, generally speaking, in the low-[20s] months, right, and so, as I was saying before, consistent, generally, with what we saw in the HARMONi-6 OS analysis, as well as what we saw in terms of the Western follow-up for patients in the HARMONi study.

是的。我想第二個問題可能比較容易回答：當我們到2027年上半年時，一般而言我們預期中位隨訪時間會在20個月出頭（low-[20s] months）左右；因此，如我先前所說，整體上會與我們在HARMONi-6 OS分析中看到的，以及HARMONi研究中西方患者的隨訪情況所見一致。

And so, with respect to the first question on not being dominated by early progressors, part of that also includes, the larger sample size takes that effect away.

因此，關於第一個問題——不被早期進展者所主導——其中一部分也包括：較大的樣本數會把那種影響消除掉。

And so, with the smaller sample size, you run more variability. And so you could be more dominated with unexpected answers, if you will.

因此，在較小的樣本數下，你會看到更大的變異性。因此，如果你願意這麼說的話，你可能更容易被一些出乎意料的結果所主導。

With respect to, if you have a few more patients who progress early or pass away earl, With a smaller sample size, you have a little bit more variability in what you see there.

另外，如果你有多幾位病人很早就進展或較早死亡，在較小的樣本數下，你在那裡看到的結果就會有更大的變異性。

With a larger sample size, with what we see in squamous, unfortunately, those patients pass on a little bit earlier so that doesn't require quite as large of a sample size.

在較大的樣本數下，就我們在鱗狀細胞癌所看到的情況而言，不幸的是，那些病人會稍早一些離世，因此不需要那麼大的樣本數。

But for the squamous and non-squamous, we have what we believe is a sufficient sample size in order to be able to avoid any of that statistical noise and variability that you can see.

但對於鱗狀與非鱗狀，我們認為樣本數已足夠，可以避免你可能看到的統計雜訊與變異性。

I would just add, unlike the KEYNOTE-024, 042 studies, which were monotherapy [IO], this includes chemotherapy so it should prevent early progression.

我再補充一點：不同於 KEYNOTE-024、042 研究是單藥治療[IO]，這裡包含化療，因此應可防止早期進展。

The chemo will control the disease early in both cohorts and allow the IO to take it back.

化療會在兩個隊列中於早期控制疾病，並讓 IO 之後把效果接手回來。

David Dai, UBS.

UBS 的 David Dai。

Great. Thanks for taking my questions.

很好。謝謝回答我的問題。

For the updated HARMONi data that you were presenting yesterday, could you help us understand the maturity of the updated OS data set, relative to the September 2025 analysis; and whether the incremental follow-up meaningfully increased the number of OS events observed?

針對你們昨天展示的更新版 HARMONi 數據，能否幫我們理解：相較於 2025 年 9 月的分析，更新後 OS 數據集的成熟度如何；以及額外的追蹤是否有意義地增加了觀察到的 OS 事件數？

We just want to get a sense of whether the investor should really focus on the incremental improvements for [HR] from [0.78] to [0.76] or the fact the OS benefit remains stable, despite a substantially longer Western follow-up.

我們想了解投資人究竟應該更聚焦於[HR]從[0.78]到[0.76]的增量改善，還是應該聚焦於：儘管西方地區追蹤時間大幅延長，OS 受益仍然保持穩定這一點。

Yeah. David, I think part of the main take-away from the analysis yesterday, right, is that, with meaningful follow-up in both regions -- Asian and Western -- you have a similar magnitude of benefit, right?

是的。David，我認為昨天分析的主要重點之一是：在亞洲與西方兩個地區都有具意義的追蹤後，你看到的是相近幅度的獲益，對吧？

I think, as everybody is well aware, the HARMONi study was effectively enrolled, first, in China; a pause; and then, enrolled in the West.

我想大家都很清楚，HARMONi 研究基本上是先在中國入組；中間暫停；然後再在西方入組。

That was based on the timing of when we did the transaction to in-license ivonescimab with our partners at Akeso, right? That's a little bit driven based on the circumstances of timing of the transaction and what was already enrolled at the time.

這是基於我們何時與合作夥伴 Akeso 完成交易、引進授權 ivonescimab 的時間點，對吧？這在某種程度上是由交易時點的情況，以及當時已經入組的受試者所驅動。

When we look at the study, as a whole, EGFR-mutation-positive lung cancer is a disease that is more prevalent in Asian patients.

當我們看整個研究時，EGFR 突變陽性肺癌在亞洲病人中更為常見。

And so we would expect a higher proportion of patients to be enrolled in Asia, as is typical and has been run with the osimertinib studies, some of the amivantamab studies, so on and so forth.

因此我們預期在亞洲入組的比例會更高，這也很典型；在 osimertinib 的研究、部分 amivantamab 的研究等，都是這樣進行的。

And so (inaudible) -- because of that, it's about 60% Asian and about 40% Western; again, typical split, with respect to that for EGFR-mutation-positive.

因此（聽不清）——因為這個原因，大約 60% 是亞洲、約 40% 是西方；同樣地，這是 EGFR 突變陽性常見的分布。

When we look at the global survival analysis, overall, we saw pretty consistent results with the HARMONi-A study that was China only and the HARMONi study, which was important because there was no clear detriment that was being seen from Western patients, with very early follow-up time at the beginning.

當我們看全球存活分析時，整體而言，我們看到與僅中國的 HARMONi-A 研究以及 HARMONi 研究相當一致的結果；這很重要，因為在一開始西方病人的追蹤時間非常短時，並沒有看到明顯的不利影響。

As that follow-up time matured, what we saw is the Western patients really merged in and saw the same magnitude of benefit with the Asian patients.

隨著追蹤時間更成熟，我們看到西方病人的結果確實趨於一致，並且與亞洲病人呈現相同幅度的獲益。

We saw across, the whole study, a consistent magnitude of benefit, irrespective of when we looked at the data. And so we saw the 0.79, 0.78 in the follow-up shortly, thereafter, the primary; and then, the 0.76 that was announced yesterday.

我們在整個研究中看到一致的獲益幅度，不論我們在何時點查看數據。因此，在主要分析後不久的追蹤中，我們看到 0.79、0.78；然後是昨天公布的 0.76。

We're seeing that consistent magnitude of benefit. What we see is, when the Western subgroup has additional maturity and those patients progress along the Kaplan-Meier curve, if you will, they have the same magnitude of benefit.

我們看到的是一致的獲益幅度。我們看到的是：當西方亞組有更多成熟度、那些病人沿著 Kaplan-Meier 曲線推進時（如果你願意這麼說），他們呈現相同幅度的獲益。

I think our real take-away is the importance of follow-up time; the importance of the maturity of the data; and that, ultimately, the consistency by which we saw the Western patients perform, when they had meaningful time on study. I think that was important.

我認為我們真正的重點是追蹤時間的重要性、數據成熟度的重要性；以及最終在西方病人有足夠的研究時間後，我們看到他們表現的一致性。我認為這點很重要。

Got it. Thanks. And then, just want to follow up: You stated yesterday that the updated HARMONi data was provided to the FDA.

了解。謝謝。接著想追問：你昨天提到更新的 HARMONi 數據已提供給 FDA。

Can you just discuss whether the agency specifically requested this data and whether you have received any feedback regarding how the FDA views the more mature survival data, so far?

你能否談談：主管機關是否特別要求這份數據；以及到目前為止，你們是否收到任何回饋，關於 FDA 如何看待更成熟的存活數據？

Yeah. The data, itself, is a recently performed analysis. Even though the data cut-off is in June, it still takes a little bit of time to clean the data and finalize before performing.

是的。這份數據本身是最近才完成的分析。即使數據截點在 6 月，仍需要一些時間進行數據清理與定稿，之後才能執行分析。

We've recently performed this analysis. And so we have not received meaningful feedback in the short time since we made this data available to the FDA.

我們最近才完成這項分析。因此，在我們把這份數據提供給 FDA 之後的短時間內，我們尚未收到有意義的回饋。

Ultimately, we believe this data is important in the context of the full story, regarding the HARMONi trial and the potential benefit of ivonescimab in the EGFR-mutation-positive setting; in particular, including those patients in the US, given the specific health authority in which we're seeking approval in the US.

最終，我們認為這份數據在完整敘事脈絡中很重要，關於 HARMONi 試驗以及 ivonescimab 在 EGFR 突變陽性情境下的潛在獲益；特別是包含美國的病人，因為我們正在美國向特定主管機關尋求核准。

Got it. Thank you so much.

了解。非常感謝。

Reni Benjamin, Citizens.

Citizens 的 Reni Benjamin。

Hey. Thanks, guys, for taking the questions. Congratulations on the progress.

嗨。謝謝各位回答問題。恭喜進展順利。

Maybe just starting off with the upcoming PDUFA date, do you think this filing with the updated OS could result in a major amendment and a potential pushing back of the PDUFA date? Do you think, likely, this is going to progress as scheduled? Do you think that an ODAC panel could potentially be convened for this application?

先從即將到來的 PDUFA 日期開始，你們認為這次提交更新 OS 的申報，是否可能構成重大修訂（major amendment），並可能導致 PDUFA 日期往後延？你們認為大概率會按原定時程推進嗎？你們認為此申請是否可能召開 ODAC 諮詢委員會？

And then, just as a follow-up, if we take a step back and just look at the landscape, I'm curious as to how you guys are thinking about the competitive positioning, given the amivantamab data, some emerging Trop2 ADC data.

另外再追問一下，如果我們退一步看整體版圖，我很好奇你們如何思考競爭定位：考量到 amivantamab 的數據，以及一些新出現的 Trop2 ADC 數據。

Do you guys feel that ivonescimab will be in this sandbox and playing with everyone else? Is there certain competitive edges that could squeeze other players out? How are you thinking about it?

你們覺得 ivonescimab 會在這個沙盒裡，跟其他人一起競爭嗎？是否有某些競爭優勢可能把其他玩家擠出去？你們怎麼看？

Thanks for the question, Reni.

謝謝你的問題，Reni。

I think, with respect to the PDUFA date, this is a new analysis. Again, we recently submitted this analysis to the agency.

我想，關於 PDUFA 日期，這是一個新的分析。同樣地，我們最近才把這項分析提交給主管機關。

We don't have an expectation of the PDUFA date moving but that's really a determination to be made by the agency so we fully defer. That's ultimately their call, should they decide that.

我們不預期 PDUFA 日期會變動，但這確實是由主管機關決定，因此我們完全尊重其判斷。最終是否要那樣做，是他們的決定。

The same holds true for any advisory committee or ODAC, as well. That's really exclusively an agency decision.

至於任何諮詢委員會或 ODAC 也是一樣。那完全是主管機關的決定。

With respect to where does ivonescimab fit in terms of competitive landscape and whatnot, I think, as we look at these two agents, right now, that currently have some level of approval with the FDA -- there's a full approval for amivantamab in combination with chemotherapy; and then, there's -- as well as the datopotamab -- accelerated approval -- with respect to post-TKI and post-chemo, which is a little bit different than the indication that we're seeking, as well as the indication that amivantamab in combination with chemo has.

至於 ivonescimab 在競爭版圖中的定位等，我認為，當我們看目前這兩個已在 FDA 取得某種程度核准的藥物時——amivantamab 與化療合併已獲得完整核准；另外還有——datopotamab 在 TKI 後、化療後的情境下獲得加速核准——這與我們正在尋求的適應症略有不同，也與 amivantamab 合併化療所擁有的適應症不同。

Look, I think, from an efficacy perspective, as Maky had mentioned, no compound, at this point, has shown a statistically significant overall survival benefit.

你看，我認為，從療效的角度來看，正如 Maky 提到的，目前為止，沒有任何化合物顯示在整體存活期（OS）上具有統計上顯著的獲益。

If we look at the efficacy profile, overall, with respect to what we saw from the Mariposa-2 trial from the amivantamab plus chemotherapy, we see -- they're cross-trial comparisons, which is important, but generally consistent efficacy profile.

如果我們看整體的療效概況，就我們在 Mariposa-2 試驗中看到的 amivantamab 加化療而言，我們看到——這些是跨試驗比較，這點很重要——但整體而言，療效概況大致一致。

I think what we've shown with over 4,000 patients dosed across several different settings of clinical studies, we've shown a manageable safety profile that's consistent, generally speaking, irrespective of tumor type; irrespective of line of therapy; irrespective of histology.

我認為，我們在超過 4,000 名患者、於多個不同臨床研究情境中完成給藥後，已證明其安全性概況可管理且一致；一般而言，不論腫瘤類型、不論治療線別、不論組織學類型，皆是如此。

We've received a lot of KOL feedback, with respect to the manageability and the tolerability of ivonescimab. I think that's really important here.

我們收到了許多 KOL 的回饋，關於 ivonescimab 的可管理性與耐受性。我認為這在此處非常重要。

Obviously, datopotamab comes with a chemotherapy component, if you will; with a payload. And so all three regimens have a cytotoxic component.

顯然，datopotamab 帶有一個化療成分（如果你願意這麼說的話）；也就是帶有一個載荷（payload）。因此，這三種方案都包含細胞毒性成分。

And so, I think, overall, it becomes -- there's also -- I think the other thing that's really important: There's also patients who will respond to different mechanisms.

所以我認為，整體而言，這就變成——另外——我認為另一個非常重要的點是：也會有患者對不同機制產生反應。

All three of these agents, the two that are approved -- either accelerated or fully; and then, the potential for the approval for ivonescimab would be three different components.

這三個藥物中，已有兩個獲批——不論是加速核准或完全核准；而 ivonescimab 潛在的核准，將會是三個不同的組成部分。

I think that provides physicians and patients with opportunities to mechanistically work differently from each other. A patient may respond to one and not the other.

我認為這為醫師與患者提供了在機制上彼此不同的治療選擇。患者可能對其中一個有反應、對另一個則沒有。

That choice is a good thing for physicians treating patients and for patients, themselves. I think that's something that really differentiates this ,as opposed to maybe coming in with the same mechanism of action that we see in other spaces, sometimes.

這樣的選擇對治療患者的醫師以及患者本身都是好事。我認為這點確實形成差異化，相較於有時在其他領域看到的、以相同作用機制切入的情況。

Great. Thanks for taking the questions.

很好。謝謝你回答問題。

Eric Schmidt, Cantor.

Eric Schmidt，Cantor。

Thank you for taking my question.

謝謝讓我提問。

Just coming back to HARMONi-3, I think this is the first time we're hearing about two interim analyses. Just want to confirm that that's always been the game plan, even if you haven't talked about it; and that you're spending alpha on all three of these looks.

回到 HARMONi-3，我想這是我們第一次聽到有兩次期中分析。我只是想確認，這一直都是既定計畫，即使你們之前沒有談到；而且你們會在這三次觀察（looks）上都花費 alpha。

Eric, what I'd say is, we've talked about OS analyses -- plural -- multiple times. I don't know if we've given the timing of the first-half 2027 before.

Eric，我想說的是，我們多次談到 OS 分析——複數——也就是多次分析。我不確定我們之前是否提過第一次分析的時間點會在 2027 年上半年。

And so I think part of -- as we look, we want to make sure we're transparent, with respect to when the opportunities exist for results at different periods of time.

因此我認為其中一部分——當我們在看時，我們希望確保透明，讓大家知道在不同時間點有哪些機會可以取得結果。

Obviously, we look at the OS analysis coming up. We look at follow-up time; what we've learned from, HARMONi, HARMONi-6; and so on and so forth.

顯然，我們會看即將到來的 OS 分析。我們會看隨訪時間；以及我們從 HARMONi、HARMONi-6 等等所學到的經驗。

Ands so with that follow-up time being important, we wanted to make sure that was highlighted for everyone.

因此，鑑於隨訪時間的重要性，我們希望確保這點能讓大家注意到。

There's alpha spent on all three days?

三次都會花費 alpha 嗎？

They're formal analyses. That's right.

它們都是正式分析。沒錯。

Okay. One thing we didn't hear much about was your pre-commercial preparation, in advance of the November 14 PDUFA date for HARMONi. Is that tracking as expected? Are you hiring field force or medical-science liaisons? How's that going? Thank you.

好的。有一件我們沒怎麼聽到的是，你們在 11 月 14 日 HARMONi 的 PDUFA 日期之前的商業化前置準備。進度是否如預期？你們是否在招募前線團隊或醫藥科學聯絡員（MSL）？進展如何？謝謝。

Yeah. Hey, Eric. This is Manmeet. As Maky mentioned in her prepared remarks, right, we are extensively preparing for our commercial launch with the anticipated PDUFA date of November 14.

是的。嗨，Eric。我是 Manmeet。如同 Maky 在事先準備的發言中提到的，我們正針對預期 11 月 14 日的 PDUFA 日期，廣泛地為商業上市做準備。

We have already hired all the leadership team with extensive experience, with both biotechs and pharma, who have multiple launch experiences.

我們已經聘用了整個領導團隊，成員在生技與藥廠都有豐富經驗，並且有多次上市（launch）經驗。

We have market-access team in place. We have marketing folks in place. Obviously, when you're talking about the field force, that generally comes a few weeks before the PDUFA date. But, yes, we have all the planning and all the work under play.

我們已建立市場准入（market access）團隊。我們也已配置行銷人員。當然，談到前線團隊（field force），通常會在 PDUFA 日期前幾週才到位。但，是的，我們所有規劃與工作都在進行中。

I would just add on.

我再補充一下。

Thank you, Manmeet.

謝謝你，Manmeet。

Yeah. I'd agree with everything Manmeet said. And then, I -- also, you asked specifically about MSLs, as well, which we have ramped up in support of each of the things that Manmeet highlighted.

是的。我同意 Manmeet 說的每一點。另外，我——你也特別問到 MSL，我們也已加速擴編，以支援 Manmeet 所強調的各項工作。

Thank you, Dave. Yeah. I totally agree. Yeah. We've already ramped up the MSLs.

謝謝你，Dave。是的。我完全同意。是的。我們已經擴編了 MSL 團隊。

Thanks, guys.

謝謝各位。

Dara Azar, Stifel.

Dara Azar，Stifel。

Hi. Congrats on all the progress.

嗨。恭喜你們取得所有進展。

I have a question on alpha spending and its potential impact on HARMONi-3 squamous OS. I'm curious, what gives you confidence that you can afford the alpha for another look at OS in the HARMONi-3 squamous next year, as well? Would the alpha be passed to the next analysis, if the first look is positive?

我有一個關於 alpha 花費及其對 HARMONi-3 鱗狀（squamous）OS 潛在影響的問題。我想知道，是什麼讓你們有信心，明年還能在 HARMONi-3 鱗狀的 OS 再做一次觀察並承擔相應的 alpha？如果第一次觀察結果為正向，alpha 會被傳遞到下一次分析嗎？

A quick follow-up: Is there any connection between tracking death events and the decision to add another look at the OS of squamous next year? Thanks so much.

再追問一下：追蹤死亡事件（death events）的進度，與決定明年再增加一次鱗狀 OS 觀察之間，是否有任何關聯？非常感謝。

Yeah. A couple of points there, Dara:

是的。有幾點想回應你，Dara：

I think, on the last point, we've had this look in the first half of 2027. The timing, you don't necessarily always know the timing. It's event-driven. The analysis has been there.

我想先回到最後一點，我們在 2027 年上半年就有這次觀察。時間點你不一定總是能精確掌握。它是事件驅動（event-driven）的。這個分析一直都在計畫中。

And so, the alpha spend, with respect to the primary PFS look, is pretty minimal, specifically because it's really intended to be supportive of the PFS analysis.

因此，就 alpha 花費而言，針對主要 PFS 的那次觀察，花費其實非常少，特別是因為它的目的主要是用來支持 PFS 分析。

In the -- the events reached in the second half of this year is really intended to be the primary PFS look. And then, there's a supportive look at OS.

而在——今年下半年達到的事件數，才是真正用於主要 PFS 的觀察。接著，會有一個支持性的 OS 觀察。

But that alpha spend is minimal. And so there's not a lot of concern, with respect to, if you will, "the amount spent", just based on maturity of OS at that time. It becomes pretty minimal.

但那個 alpha 花費很小。因此，對於（如果你願意這麼說）「花費的量」並不太擔心，因為當時 OS 的成熟度有限。所以花費會相當小。

And so that gives an opportunity for two full looks, if you will, thereafter. And so no real change in plan from that perspective. And so it's not like tracking death events -- I think, was the example that you gave. That's really been the plan throughout.

因此，之後仍有機會進行兩次完整的觀察（full looks）。所以從這個角度看，計畫並沒有真正改變。因此，並不是因為追蹤死亡事件——我想你舉的是這個例子。這一直都是既定計畫。

But, as we look at the maturity timelines, the first half of 2027 is a key focal point, with respect to reaching that median follow-up -- is a proxy that we've seen in both the HARMONi Western patients, where we showed that positive trending data yesterday and being more converged with the ITT in the Asian population, as well as the timing of the HARMONi-6 OS analysis, as well.

不過，當我們看成熟度的時間軸時，2027 年上半年是一個關鍵焦點，因為要達到中位數隨訪（median follow-up）——這是一個代理指標（proxy）。我們在 HARMONi 的西方患者中已看到這點：我們昨天展示了正向趨勢的數據，且與亞洲族群的 ITT 結果更趨一致；同時也與 HARMONi-6 的 OS 分析時間點相呼應。

Okay. Thank you.

好的。謝謝。

Faisal Khurshid, Jefferies.

Faisal Khurshid，Jefferies。

Hey, guys. Thank you for taking the question.

嗨，各位。謝謝讓我提問。

I wanted to actually go back to the HARMONi-3 interim PFS analysis that passed. Could you contextualize for us what was the alpha spend in that interim?

我想回到先前已通過的 HARMONi-3 期中 PFS 分析。能否請你們為我們說明一下，該次期中分析的 alpha 花費（alpha spend）是多少？

Many investors have interpreted missing that interim as suggesting that HARMONi-3 is tracking worse than HARMONi-6. Is that a correct take? Why or why not? Thank you.

許多投資人將未達到該次期中門檻解讀為 HARMONi-3 的追蹤表現比 HARMONi-6 更差。這樣的解讀正確嗎？為什麼是或為什麼不是？謝謝。

Thanks, Faisal. I think I'd probably say a couple of things to effectively answer the questions that you're asking, which is. the threshold to achieve statistical significance at the interim was meaningfully higher than that of what is needed for the final analysis; as well (inaudible) -- we continue to see follow-up time is very important with ivonescimab.

謝謝你，Faisal。我想我會從幾點來有效回答你提出的問題。首先，期中分析要達到統計顯著性的門檻，明顯高於最終分析所需的門檻；另外（聽不清）——我們持續看到，對 ivonescimab 而言，隨訪時間非常重要。

And so that is, certainly -- I think, as we talked about last time, the timing of that analysis was shortly after, as we looked at the completion of enrollment. We effectively announced completion of enrollment and then, (inaudible) -- right into that interim analysis.

因此，這當然——我想如同我們上次談到的，那次分析的時間點是在我們看到入組完成後不久。我們實際上宣布入組完成，然後（聽不清）——就直接進入那次期中分析。

And so not a lot of follow-up time for many patients on that study. Those are two reasons why I don't think it's necessarily the right way to look at it, with respect to -- different from HARMONi-6, one way or the other.

因此，該研究中許多患者的隨訪時間並不長。基於這兩點，我不認為用「期中未達門檻」來解讀它、並據此認定——相較於 HARMONi-6 變好或變差——是必要或正確的看法。

It's important also, that analysis was performed by the independent-data monitoring committee. We remain fully blinded to that data. That's not something that we have hazard ratios and additional data for.

另外也很重要的是，該次分析是由獨立資料監測委員會執行。我們仍然對該資料完全盲態。我們並沒有風險比（hazard ratios）或更多額外資料。

And so we're confidently going into the second half of this year. We've continued to learn more each time we have conducted analyses, with respect to ivonescimab; and continued to increase that confidence.

因此，我們有信心地邁向今年下半年。每次針對 ivonescimab 進行分析時，我們都持續學到更多；也持續提升這份信心。

Great. Thank you.

很好。謝謝。

Yeah. The only thing I'd add, on top of that, Faisal, obviously, as you look at the Western subgroup that we published yesterday, you see, with additional follow-up time, a pretty meaningful movement of the Western subgroups.

是的。Faisal，我唯一想補充的是，顯然，當你看我們昨天發表的西方亞組時，你會看到，隨著額外的隨訪時間，西方亞組的結果有相當明顯的變化。

It's a proxy, here, for follow-up time. (inaudible) -- talk about Western patients and more of a proxy for follow-up time but, with that additional follow-up time, you do see movement there, which is important.

在這裡它可作為隨訪時間的替代指標。（聽不清）——談到西方患者，更多是作為隨訪時間的替代指標；但隨著額外的隨訪時間，你確實看到那裡出現變化，這很重要。

Understood. Thank you.

了解。謝謝。

[Kristen Carter], Piper Sandler.

[Kristen Carter]，Piper Sandler。

Hi. This is Kristen, on for [Kelsey]. I believe you mentioned a little bit about what you've heard from KOLs. Could you expand on what they're saying, post-ASCO, for HARMONi-6, please? Thank you.

嗨。我是 Kristen，代替[Kelsey] 發問。我相信你們提到了一些你們從 KOL 那裡聽到的回饋。能否請你們在 ASCO 之後，進一步說明他們對 HARMONi-6 的看法？謝謝。

Yeah. I think the KOLs for HARMONi-6 were very positive on the data. I think some of the feedback I've heard is that, it's very encouraging.

好的。我認為 KOL 對 HARMONi-6 的數據非常正面。我聽到的一些回饋是，這非常令人鼓舞。

A 34% reduction in the risk of death is amazing over a PD-1. This is really phenomenal data.

相較於 PD-1，死亡風險降低 34% 非常驚人。這真的是非常出色的數據。

I think some of the feedback we got was that the discussant who wasn't very positive on the data missed the point of the study, right? We understood fully -- the ASCO committee understood fully that it was a regional study, right?

我們收到的一些回饋是，那位對數據不太正面的討論者其實沒有抓到研究重點，對吧？我們完全理解——ASCO 委員會也完全理解——這是一項區域性研究，對吧？

Very exciting and intriguing data. There wasn't any discussion. The fact that we would have confirmatory or global data within the end of the year -- we're less than six months away.

非常令人興奮且引人入勝的數據。當時並沒有任何爭議。而且我們會在年底前取得確認性或全球性數據——距離現在不到六個月。

And then, the other thing is that there were other studies -- three other studies -- supporting the observation that was seen there.

另外，還有其他研究——三項其他研究——支持在那裡所觀察到的結果。

In addition, there was some discussion about age effect. In any of those other three studies, there was no difference by age group.

此外，也有一些關於年齡效應的討論。在另外那三項研究中，按年齡組別並沒有差異。

In addition, the previous presentation of the HARMONi-6 data, which only had the PFS, there was an explanation of the age, based on covariates.

另外，在先前對 HARMONi-6 數據的發表中，當時只有 PFS，也曾基於共變數對年齡因素做出解釋。

Finally, the most exciting thing about this agent is that it seems to be active in diseases that weren't traditionally active for PD-1s, like microsatellite stable colorectal cancer.

最後，這個藥物最令人興奮的一點是，它似乎在一些傳統上 PD-1 並不活躍的疾病中也有活性，例如微衛星穩定型（MSS）的結直腸癌。

None of these things were highlighted in this. But this was brought up a lot by a lot of the KOLs after the meeting.

這些重點在這次並沒有被強調。但在會後，許多 KOL 都多次提到這些。

Great. Thank you so much. Congratulations, again.

很好。非常感謝。再次恭喜。

We have reached the end of the question-and-answer session.

我們已到達問答環節的結束。

I will now turn the call back to Dave for closing remarks. Please go ahead.

我現在把電話交回給 Dave 作結語。請開始。

Thanks very much. I think I will hand it over directly to Bob.

非常感謝。我想我會直接交給 Bob。

Hi. Thanks, Dave. It's good to hear from our shareholders and our fellow stakeholders.

嗨。謝謝你，Dave。很高興聽到我們股東以及其他利害關係人的聲音。

Over the years, from nothing, I've raised over $1 billion of after-tax money in support of healthcare companies, whether they be drug or medical devices.

多年來，從無到有，我已募集超過 10 億美元的稅後資金，用於支持醫療保健公司，無論是藥品或醫療器材。

It's been fun coming up with a vision and putting a team together for execution and watching the companies proceed.

提出願景、組建團隊來執行，並看著公司向前推進，這一直很有趣。

We know that ivonescimab works. And so the question I leave you with is: What if ivonescimab works really well?

我們知道 ivonescimab 有效。因此我留給各位的問題是：如果 ivonescimab 的效果非常好，會怎麼樣？

Have a good day.

祝各位有美好的一天。

This concludes today's call. Thank you for attending. You may now disconnect.

今天的電話會議到此結束。感謝各位參與。您現在可以掛線。