MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) ('Summit,' 'we,' or the 'Company') today announced data from the primary analysis of the Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab. The data was presented this morning as part of the Presidential Symposium at the International Association for the Study of Lung Cancer’s (IASLC) 2024 World Conference on Lung Cancer (WCLC 2024) in San Diego, California..

迈阿密--（商业新闻短讯）--Summit Therapeutics Inc.（纳斯达克：SMMT）（“Summit”，“we”或“公司”）今天宣布了来自III期HARMONi-2试验的初步分析数据，该试验具有新颖的，潜在的一流研究性双特异性抗体ivonescimab。这些数据是今天上午在加利福尼亚州圣地亚哥举行的国际肺癌研究协会（IASLC）2024年世界肺癌会议（WCLC 2024）总统研讨会上公布的。。

The HARMONi-2 presentation, Phase 3 Study of Ivonescimab (AK112) vs. Pembrolizumab as First-line Treatment for PD-L1-positive Advanced NSCLC: Primary Analysis of HARMONi-2, evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).

HARMONi-2介绍，Ivonescimab（AK112）与Pembrolizumab作为PD-L1阳性晚期非小细胞肺癌一线治疗的3期研究：HARMONi-2的初步分析，评估了单药治疗Ivonescimab对单药治疗Pembrolizumab的疗效。局部晚期或转移性非小细胞肺癌（NSCLC）患者的肿瘤PD-L1表达阳性（PD-L1 TPS>1%）。

HARMONi-2 is a single region, multi-center, double-blinded Phase III study conducted in China sponsored by our collaboration partner, Akeso, Inc. (Akeso, HKEX Code: 9926.HK), with data generated and analyzed by Akeso..

HARMONi-2是一项在中国进行的单区域、多中心、双盲III期研究，由我们的合作伙伴Akeso，Inc.（Akeso，香港交易所代码：9926。HK）赞助，数据由Akeso生成和分析。。

The trial results were presented by Professor Caicun Zhou, MD, PhD, Chief Physician and Director of the Department of Medical Oncology at Shanghai Pulmonary Hospital, Tongji University School of Medicine, and President-Elect of IASLC.

试验结果由同济大学医学院上海肺科医院主任医师兼肿瘤内科主任周彩村教授、医学博士、博士和IASLC当选主席介绍。

Clinically Meaningful Efficacy

具有临床意义的疗效

In the HARMONi-2 primary analysis, ivonescimab monotherapy demonstrated a statistically significant improvement in the trial’s primary endpoint, progression-free survival (PFS) by Independent Radiologic Review Committee (IRRC), when compared to monotherapy pembrolizumab, achieving a hazard ratio (HR) of 0.51 (95% CI: 0.38, 0.69; p<0.0001).

在HARMONi-2初步分析中，与单药治疗pembrolizumab相比，独立放射学审查委员会（IRRC）的ivonescimab单药治疗显示该试验的主要终点无进展生存期（PFS）有统计学显着改善，风险比（HR）为0.51（95%CI:0.38,0.69；p＜0.0001）。

A clinically meaningful benefit was demonstrated across clinical subgroups, including those with PD-L1 low expression (PD-L1 TPS 1-49%), PD-L1 high expression (PD-L1 TPS ≥ 50%), squamous and non-squamous histologies, as well as other high-risk patients. Both the overall response rate (ORR) measured according to RECIST v1.1 criteria as well as the disease control rate (DCR) were higher in patients treated with ivonescimab compared to those treated with pembrolizumab..

在临床亚组中证实了临床上有意义的益处，包括PD-L1低表达（PD-L1 TPS 1-49%），PD-L1高表达（PD-L1 TPS≥50%），鳞状和非鳞状组织学以及其他高危患者。与使用pembrolizumab治疗的患者相比，使用ivonescimab治疗的患者根据RECIST v1.1标准测量的总体缓解率（ORR）以及疾病控制率（DCR）均更高。。

HARMONi-2 ITT (n=398);

HARMONi-2 ITT（n=398）；

Median Follow-up: 8.67 mos

中位随访时间：8.67个月

Ivonescimab

Ivonescimab

(n=198)

（n=198）

Pembrolizumab

Pembrolizumab

(n=200)

（n=200）

Median PFS

中位PFS

11.14 mos

11.14个月

(95% CI: 7.33, NE)

（95%置信区间：7.33，NE）

5.82 mos

5.82个月

(95% CI: 5.03, 8.21)

（95%置信区间：5.03、8.21）

PFS Stratified HR

PFS分层人力资源

0.51

0.51

(95% CI: 0.38, 0.69; p<0.0001)

（95%置信区间：0.38、0.69；p<0.0001）

ORR

ORR

50.0%

50.0%

(95% CI: 42.8%, 57.2%)

（95%置信区间：42.8%，57.2%）

38.5%

38.5%

(95% CI: 31.7%, 45.6%)

（95%置信区间：31.7%，45.6%）

DCR

DCR

89.9%

89.9%

(95% CI: 84.8%, 93.7%)

（95%置信区间：84.8%，93.7%）

70.5%

70.5%

(95% CI: 63.7%, 76.7%)

（95%置信区间：63.7%，76.7%）

HARMONi-2 Subgroup Analyses

HARMONi-2亚组分析

Ivonescimab vs. Pembrolizumab

Ivonescimab vs Pembrolizumab

PD-L1 High (PD-L1 TPS ≥50%) PFS stratified HR

PD-L1高（PD-L1 TPS≥50%）PFS分层HR

Ivonescimab n=83; Pembrolizumab n=85

Ivonescimab n=83；Pembrolizumab n=85

0.46

0.46

(95% CI: 0.28, 0.75)

（95%置信区间：0.28、0.75）

PD-L1 Low (PD-L1 TPS 1-49%) PFS stratified HR

PD-L1低（PD-L1 TPS 1-49%）PFS分层HR

Ivonescimab n=115; Pembrolizumab n=115

Ivonescimab n=115；Pembrolizumab n=115

0.54

0.54

(95% CI: 0.37, 0.79)

（95%置信区间：0.37、0.79）

Squamous histology PFS stratified HR

鳞状组织学PFS分层HR

Ivonescimab n=90; Pembrolizumab n=91

Ivonescimab n=90；Pembrolizumab n=91

0.48

0.48

(95% CI: 0.31, 0.74)

（95%置信区间：0.31、0.74）

Non-Squamous histology PFS stratified HR

非鳞状组织学PFS分层HR

Ivonescimab n=108; Pembrolizumab n=109

Ivonescimab n=108；Pembrolizumab n=109

0.54

0.54

(95% CI: 0.36, 0.82)

（95%置信区间：0.36、0.82）

Overall survival data was not yet mature at the time of the data cutoff and will be evaluated in the future.

总体生存数据在数据截止时尚未成熟，将在未来进行评估。

Manageable Safety Profile

可管理的安全概况

Ivonescimab demonstrated an acceptable and manageable safety profile, which was consistent with previous studies. There were three patients (1.5%) who discontinued ivonescimab due to TRAEs compared to six patients (3.0%) who discontinued pembrolizumab due to TRAEs. There was one patient in the ivonescimab arm and two patients in the pembrolizumab arm who died as a result of TRAEs in this Phase III study.

Ivonescimab表现出可接受且可管理的安全性，这与之前的研究一致。有3名患者（1.5%）因TRAEs停用了ivonescimab，而6名患者（3.0%）因TRAEs停用了pembrolizumab。在这项III期研究中，ivonescimab组有一名患者，pembrolizumab组有两名患者因TRAEs死亡。

The most frequent treatment-related adverse events (TRAEs) for ivonescimab treatment were proteinuria (Grade 3+: ivonescimab, 3.0%; pembrolizumab 0.0%), hypertension (Grade 3+: ivonescimab, 5.1%; pembrolizumab 0.5%), and various laboratory abnormalities, including AST increases, hypercholesterolemia, anemia, and bilirubin increases.

ivonescimab治疗最常见的治疗相关不良事件（TRAEs）是蛋白尿（3级+：ivonescimab，3.0%；pembrolizumab 0.0%），高血压（3级+：ivonescimab，5.1%；pembrolizumab 0.5%）和各种实验室异常，包括AST升高，高胆固醇血症，贫血和胆红素升高。

Grade 3 or higher immune-related adverse events occurred in 7.1% of patients receiving ivonescimab and 8.0% of patients receiving pembrolizumab. Grade 3 or higher adverse events that were possibly VEGF-related in the ivonescimab monotherapy arm were 10.2% vs. 1.0% for pembrolizumab, all of which were classified as Grade 3.

接受ivonescimab治疗的患者中有7.1%发生3级或更高的免疫相关不良事件，接受pembrolizumab治疗的患者中有8.0%发生3级或更高的免疫相关不良事件。在ivonescimab单药治疗组中可能与VEGF相关的3级或更高级别不良事件为10.2%，而pembrolizumab为1.0%，所有这些都被归类为3级。

Of note, Grade 3 hemorrhage events were observed in two patients in the ivonescimab arm (both were of non-squamous histology) compared to one patient in the pembrolizumab arm in this study..

值得注意的是，与本研究中pembrolizumab组的一名患者相比，ivonescimab组的两名患者（均为非鳞状组织学）观察到3级出血事件。。

HARMONi-2

和声-2

(n=396)

（n=396）

Ivonescimab

Ivonescimab

(n=197)

（n=197）

Pembrolizumab

Pembrolizumab

(n=199)

（n=199）

TRAEs Grade 3+

TRAE 3级+

29.4%

29.4%

15.6%

15.6%

Serious TRAEs (TRSAEs)

严重不良反应（TRSAE）

20.8%

20.8%

16.1%

16.1%

TRAEs Leading to Drug Discontinuation

导致停药的TRAEs

1.5%

1.5%

3.0%

3.0%

TRAEs Leading to Death

导致死亡的陷阱

0.5%

0.5%

1.0%

1.0%

Grade 3+ Immune-related

3级以上免疫相关

7.1%

7.1%

8.0%

8.0%

Grade 3+ Possibly VEGF-related*

3级+可能与VEGF相关*

10.2%

10.2%

1.0%

1.0%

*All Grade 3+ adverse events that were possibly VEGF-related were classified as Grade 3 events in both arms; there were no Grade 4 or 5 adverse events that were possibly VEGF-related observed in either arm.

*所有可能与VEGF相关的3级以上不良事件均被归类为双臂3级事件；在任一组中均未观察到可能与VEGF相关的4级或5级不良事件。

“This is a historic moment for ivonescimab, Team Summit, our partners at Akeso, and most importantly, we believe this is the beginning of a landscape shift for treatment options for patients living with cancer,” stated Robert W. Duggan, Chairman and Chief Executive Officer of Summit. “We are incredibly proud of our partnership with Akeso and their accomplishment with HARMONi-2.”.

Summit主席兼首席执行官罗伯特·达根（RobertW.Duggan）表示：“这对我们在阿克索的合作伙伴ivonescimab来说是一个历史性的时刻，最重要的是，我们认为这是癌症患者治疗选择格局转变的开始。”。“我们为我们与Akeso的合作以及他们在HARMONi-2上取得的成就感到无比骄傲。”。

Based on the results of HARMONi-2, Summit announced its intention to initiate HARMONi-7 in early 2025. HARMONi-7 is currently planned as a multi-regional Phase III clinical trial that will compare ivonescimab monotherapy to pembrolizumab monotherapy in patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 TPS > 50%)..

根据HARMONi-2的结果，峰会宣布打算在2025年初启动HARMONi-7。HARMONi-7目前计划作为一项多区域III期临床试验，将比较伊伐昔单抗单药疗法和派姆单抗单药疗法在转移性非小细胞肺癌患者中的疗效，这些患者的肿瘤具有高的帕金森病相关蛋白1表达水平（>50%）。。的肿瘤相关蛋白1表达水平高于其他肿瘤相关蛋白1表达水平。的患者。。的临床试验结果表明，该药物的临床疗效与其他药物相比，具有更高的临床。。

“HARMONi-2 clearly demonstrates that ivonescimab has the potential to be the next generation in PD-1 directed immunotherapy, and potentially make a significant difference in the lives of patients with lung cancer and prospectively other tumors,” added Dr. Maky Zanganeh, Chief Executive Officer and President of Summit.

Summit首席执行官兼总裁Maky Zanganeh博士补充道：“HARMONi-2清楚地表明，ivonescimab有可能成为PD-1定向免疫治疗的下一代，并可能对肺癌患者和其他肿瘤患者的生活产生重大影响。”。

“We want to again congratulate Akeso for this incredible result and their work to advance the patient-friendly standards of care today and well into the future. We look forward to initiating HARMONi-7 and sharing additional details about our expanded clinical development plan in early 2025.”.

“我们要再次祝贺 Akeso 取得这一令人难以置信的成果，并祝贺他们在今天和未来为推进患者友好型护理标准所做的工作。我们期待着在 2025 年初启动 HARMONi-7 并分享我们扩大临床开发计划的更多细节。

Phase II Perioperative NSCLC

II期围手术期非小细胞肺癌

In addition to the HARMONi-2 data presentation, a second oral presentation featuring ivonescimab was presented by Xiaoliang Zhao, MD, Deputy Chief Physician, Department of Lung Cancer at Tianjin Medical University Cancer Institute & Hospital, and Visiting Scholar at the Lombardi Comprehensive Cancer Center at Georgetown University in Washington, D.C.

除了HARMONi-2数据演示之外，天津医科大学癌症研究所和医院肺癌科副主任医师赵晓亮医学博士以及华盛顿特区乔治敦大学伦巴第综合癌症中心的访问学者还介绍了第二次以ivonescimab为主题的口头演示。

The presentation was entitled, A Phase II Study of Perioperative Ivonescimab Alone or Combined with Chemotherapy in Resectable Non-Small Cell Lung Cancer, presenting the results from AK112-205, a single-region (China), multi-center, open-label Phase II study of patients with Stage II or III resectable NSCLC..

该报告的标题为围手术期Ivonescimab单独或联合化疗治疗可切除非小细胞肺癌的II期研究，介绍了AK112-205的结果，这是一项针对II期或III期可切除NSCLC患者的单区域（中国）多中心开放标签II期研究。。

The study is designed to assess patients receiving either ivonescimab monotherapy or ivonescimab plus chemotherapy prior to surgical resection and then ivonescimab monotherapy after surgery. Due to the maturity of the data and the timing of the data cutoff, the results were limited to the neo-adjuvant, or pre-surgery, portion of the clinical trial.

该研究旨在评估在手术切除前接受ivonescimab单药治疗或ivonescimab加化疗的患者，然后在手术后接受ivonescimab单药治疗。由于数据的成熟度和数据截止的时间，结果仅限于临床试验的新辅助或手术前部分。

At the time of data cutoff, 49 patients had been enrolled into the ivonescimab plus chemotherapy arm in the neo-adjuvant setting; of these 49 patients, 39 went on to complete surgery..

在数据截止时，49名患者已被纳入新辅助治疗中的ivonescimab加化疗组；在这49名患者中，有39名继续完成手术。。

Of the 39 patients who received ivonescimab plus chemotherapy in the neo-adjuvant stage and completed surgery, 71.8% of patients experienced a major pathological response (MPR) and 43.6% of patients experienced a pathological complete response (pCR). In the 49 patients enrolled in this cohort, median event-free survival (EFS) was not yet reached after 8.9 months of median follow-up time; the 12-month EFS rate was 80.3% (95% CI: 59.6, 91.1).

。在该队列的49名患者中，中位随访时间为8.9个月后，中位无事件生存期（EFS）尚未达到；12个月EFS率为80.3%（95%CI:59.6,91.1）。

These results are encouraging compared to the historical data that has been observed in global pivotal studies in a similar setting. The safety profile was manageable: of the 49 patients who received ivonescimab plus chemotherapy in the neo-adjuvant setting, Grade 3 or higher adverse events were observed in 32.7% of patients; there was one patient who experienced a treatment-related serious adverse event.

与类似环境下全球关键研究中观察到的历史数据相比，这些结果令人鼓舞。安全性是可控的：在新辅助治疗中接受ivonescimab加化疗的49例患者中，32.7%的患者出现3级或更高级别的不良事件；有一名患者经历了与治疗相关的严重不良事件。

There were no TRAEs leading to delayed or cancelled surgery or that led to the death of a patient..

没有TRAEs导致手术延迟或取消或导致患者死亡。。

Additional Phase II Data to be Presented at ESMO 2024

将在ESMO 2024上提交的其他二期数据

Beyond the data recently featured at WCLC 2024, Phase II data featuring ivonescimab will be presented at the European Society of Medical Oncology (ESMO) Congress 2024. ESMO 2024 will take place in Barcelona, Spain, from September 13 – 17, 2024.

除了最近在WCLC 2024上发布的数据外，以ivonescimab为特征的第二阶段数据将在2024年欧洲医学肿瘤学会（ESMO）大会上发布。2024年ESMO将于2024年9月13日至17日在西班牙巴塞罗那举行。

These presentations, which will feature data from studies sponsored by Akeso including first-line treatment for triple-negative advanced breast cancer (TNBC), first-line treatment for advanced head and neck squamous cell carcinoma (HNSCC), and first-line treatment of advanced colorectal cancer (CRC)..

这些演讲将展示由Akeso赞助的研究数据，包括三阴性晚期乳腺癌（TNBC）的一线治疗，晚期头颈部鳞状细胞癌（HNSCC）的一线治疗以及晚期结直肠癌（CRC）的一线治疗。。

About the ESMO 2024 Presentations

关于ESMO 2024演示文稿

Presentation Title: The efficacy and safety of ivonescimab with or without ligufalimab in combination with FOLFOXIRI (chemotherapy) as first-line treatment for metastatic colorectal cancer (mCRC)

演讲标题：依伐单抗联合或不联合利古法利玛联合FOLFOXIRI（化疗）作为转移性结直肠癌（mCRC）一线治疗的疗效和安全性

ESMO Presentation No.: 514MO

ESMO演示编号：514MO

Session Date & Time: Saturday, September 14, 3:50 to 3:55pm CET

课程日期：9月14日，星期六，欧洲中部时间下午3:50至3:55

Presentation Title: The safety and efficacy of ivonescimab in combination with chemotherapy as first-line treatment for triple-negative breast cancer (TNBC)

演讲标题：ivonescimab联合化疗作为三阴性乳腺癌（TNBC）一线治疗的安全性和有效性

ESMO Presentation No.: 347MO

ESMO演示编号：347MO

Session Date & Time: Monday, September 16, 8:30 to 8:35pm CET

会议日期：9月16日星期一，欧洲中部时间晚上8:30至8:35

Poster Title: Evaluation of the safety and efficacy of ivonescimab in combination with ligufalimab as first-line treatment for PD-L1 positive recurrent/metastasis head and neck squamous cell carcinoma (R/M HNSCC)

海报标题：评估ivonescimab联合ligufalimab作为PD-L1阳性复发/转移头颈部鳞状细胞癌（R/M HNSCC）一线治疗的安全性和有效性

ESMO Poster No.: 876P

ESMO海报编号：876P

Poster Display Date & Time: Saturday, September 14, 12:00 to 1:00pm CET

海报展示日期。时间：9月14日星期六中午12:00至下午1:00 CET

Conference Call

电话会议

Summit Therapeutics Inc. will host a conference call to discuss recent updates related to ivonescimab, including data released at WCLC, on Monday September 9, 2024, before the market opens.

Summit Therapeutics 公司将于 2024 年 9 月 9 日（星期一）开市前召开电话会议，讨论 ivonescimab 的最新进展，包括在 WCLC 上发布的数据。

Summit will host a live webcast of the conference call at 8:30am ET, which will be accessible through our website www.smmttx.com, and can also be accessed via the following link: https://events.q4inc.com/attendee/904766612.

Summit将于美国东部时间上午8:30主持电话会议的在线直播，可通过我们的网站www.smmttx.com访问，也可通过以下链接访问：https://events.q4inc.com/attendee/904766612.

The dial-in information for US attendees is toll-free at (800) 715-9871. Additionally, all attendees may access through the toll number, (646) 307-1963. The Conference ID is 9820029.

。此外，所有与会者都可以通过收费电话号码（646）307-1963访问。会议ID为9820029。

An archived edition of the webcast will be available on our website later in the day on Monday.

周一晚些时候，我们的网站将提供网络广播的存档版本。

About Ivonescimab

Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.

Ivonescimab在Summit的许可区域，美国，加拿大，欧洲，日本，拉丁美洲（包括墨西哥和中美洲，南美洲，加勒比，中东和非洲的所有国家）被称为SMT112，在中国和澳大利亚被称为AK112，是一种新型的，潜在的一流研究性双特异性抗体，它将通过阻断PD-1的免疫疗法的作用与阻断VEGF相关的抗血管生成作用结合成一个分子。

Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF..

当同时存在PD-1和VEGF时，Ivonescimab以多倍的更高亲和力显示出与每个预期靶标的独特协同结合。。

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC, 2023).

这可以区分ivonescimab，因为与体内正常组织相比，肿瘤组织和肿瘤微环境（TME）中PD-1和VEGF的表达（存在）可能更高。。

This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et al, SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets..

这种四价结构，分子的有意新颖设计，以及将这两个靶标引入具有协同结合特性的单一双特异性抗体中，有可能将ivonescimab导向肿瘤组织而不是健康组织。该设计的目的以及6至7天的半衰期（Zhong等，SITC，2023），是为了改善先前确定的疗效阈值，以及与这些目标相关的副作用和安全性。。

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,800 patients have been treated with ivonescimab in clinical studies globally.

Ivonescimab由Akeso Inc.（香港交易所代码：9926.HK）设计，目前正在进行多个III期临床试验。在全球临床研究中，已有1800多名患者接受了ivonescimab治疗。

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3, with a plan to initiate HARMONi-7 in early 2025.

Summit已开始在非小细胞肺癌（NSCLC）中开发ivonescimab的临床开发，并于2023年开始参加两项多区域III期临床试验HARMONi和HARMONi-3，计划于2025年初启动HARMONi-7。

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)..

HARMONi是一项III期临床试验，旨在评估ivonescimab联合化疗与安慰剂加化疗相比，对EGFR突变，局部晚期或转移性非鳞状非小细胞肺癌患者进行治疗后，用第三代EGFR TKI（例如osimertinib）治疗进展。。

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.

HARMONi-3是一项III期临床试验，旨在评估ivonescimab联合化疗与pembrolizumab联合化疗治疗一线转移性鳞状NSCLC患者的疗效。

HARMONi-7 is a planned Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 TPS > 50%).

HARMONi-7是一项计划进行的III期临床试验，旨在评估与pembrolizumab单药治疗相比，ivonescimab单药治疗具有高PD-L1表达（PD-L1 TPS>50%）的一线转移性NSCLC患者。

In addition, Akeso has recently had positive read-outs in two single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC, HARMONi-A and HARMONi-2.

此外，Akeso最近在两个单区域（中国）的非小细胞肺癌，HARMONi-A和HARMONi-2的ivonescimab随机III期临床试验中获得了积极的结果。

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-A是一项III期临床试验，评估了依伐昔单抗联合化疗与安慰剂加化疗相比，对EGFR突变，局部晚期或转移性非鳞状非小细胞肺癌患者进行EGFR TKI治疗后的进展情况。

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).

HARMONi-2是一项III期临床试验，评估局部晚期或转移性非小细胞肺癌患者PD-L1表达阳性（PD-L1 TPS>1%）的单药治疗依伐昔单抗对单药治疗pembrolizumab的影响。

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024.

Ivonescimab是一种研究性疗法，未经Summit许可区域（包括美国和欧洲）的任何监管机构批准。Ivonescimab于2024年5月被批准在中国上市。

About Summit Therapeutics

关于Summit Therapeutics

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs..

Summit Therapeutics Inc.是一家生物制药肿瘤公司，专注于患者，医生，护理人员和社会友好药物疗法的发现，开发和商业化，旨在改善生活质量，延长潜在寿命，并解决严重未满足的医疗需求。。

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol 'SMMT'). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.

Summit成立于2003年，我们的股票在纳斯达克全球市场（代号“SMMT”）上市。我们的总部位于佛罗里达州的迈阿密，在加利福尼亚州的门洛帕克和英国的牛津都设有办事处。