Bevacizumab

MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that, on August 12, 2026, its partner Akeso Inc. (Akeso, HKEX Code: 9926.HK) announced receipt of marketing authorization in China from the National Medical Products Administration (NMPA) for the use of ivonescimab, a novel, potential first-in-class investigational bispecific antibody, in combination with chemotherapy for the first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC). This marks the third NMPA-approved indication for an ivonescimab-containing regimen in China since the molecule’s initial approval in May 2024. The latest NMPA approval is based on the positive results of the landmark HARMONi-6 trial, a single region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. HARMONi-6 evaluates ivonescimab in combination with platinum-based chemotherapy compared to tislelizumab, a PD-1 inhibitor, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC irrespective of PD-L1 expression. Overall survival (OS) data from the Phase III HARMONi-6 trial were recently presented in the Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. HARMONi-6 demonstrated statistically significant and clinically meaningful superiority in both progression-free survival (PFS) and OS. Ivonescimab continued to demonstrate an acceptable and manageable safety profile in the HARMONi-6 study, which was consistent with previous Phase III studies of ivonescimab plus chemotherapy. “Today’s approval in China marks another extraordinary milestone for ivonescimab and reinforces the strength of the clinical evidence generated to date. HARMONi-6 is the first known Phase III study in NSCLC — or any tumor type — to demonstrate a statistically significant and clinically meaningful overall survival benefit over an anti-PD-(L)1 antibody plus chemotherapy regimen in a head-to-head setting,” said Bob Duggan, Chairman and Co-CEO of Summit. “For Summit, the HARMONi-6 results further strengthen our conviction in ivonescimab’s potential to advance beyond today’s immunotherapy standards and redefine what patients and physicians can expect from first-line cancer treatment,” said Dr. Maky Zanganeh, President and Co-CEO of Summit. “We congratulate our partner Akeso on this important approval and remain focused on accelerating the global development of ivonescimab for patients in our licensed territories.” “The NMPA approval of ivonescimab in China in combination with chemotherapy for first-line advanced squamous NSCLC represents a landmark achievement for patients, physicians and the field of oncology. Based on the HARMONi-6 trial, ivonescimab has now demonstrated both progression-free survival and overall survival superiority versus a PD-1 inhibitor plus chemotherapy regimen, establishing a new benchmark in one of the most widely treated settings in cancer care,” said Dr. Michelle Xia, Chairwoman and Chief Executive Officer of Akeso. “This third approval for an ivonescimab-containing regimen in China reflects the strength of Akeso’s innovation platform, the dedication of our clinical investigators and patients, and the transformative potential of ivonescimab as a next-generation immuno-oncology therapy. Together with Summit, we are committed to bringing the full potential of ivonescimab to patients worldwide.” In major markets globally, first-line therapy for patients with advanced NSCLC without driver mutations is most commonly a PD-1 inhibitor plus platinum-based chemotherapy. Prior to HARMONi-6, there were no known Phase III clinical trials to show a statistically significant and clinically meaningful improvement when compared to PD-(L)1 inhibitor therapy in combination with chemotherapy in a head-to-head setting, in patients with advanced NSCLC or any tumor type. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. About Ivonescimab Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, 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. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF. This design is intended to 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. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). 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 after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients when considering those treated in a commercial setting in China, as noted by Akeso. There are currently 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026. HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026. HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering. HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC. HARMONi-GU1 is a Phase II/III clinical trial evaluating ivonescimab plus the antibody drug conjugate (ADC) enfortumab vedotin (EV) compared to pembrolizumab plus EV as first-line therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC. Four Phase III ivonescimab clinical trials have read out to date, all four with positive data, in NSCLC. In addition to Summit’s positive HARMONi study, Akeso has had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in both the HARMONi-A and HARMONi-6 studies. A manageable, consistent safety profile was achieved in each of these studies. 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-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. HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer. 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 initially approved for marketing authorization in China in May 2024. About Summit Therapeutics Inc. 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 was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol "SMMT"). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK. For more information, please visit https://www.smmttx.com and follow Summit on X @SMMT_TX. Summit Forward-Looking Statements Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc. and other collaborations, the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release. Summit Therapeutics and the Summit Therapeutics logo are registered trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved.

在复发性卵巢癌的临床诊疗中，铂耐药始终是横亘在患者与医生面前的一道难关。不少患者在疾病复发后完成基因检测，发现不存在BRCA突变，便误以为彻底失去了靶向治疗的机会，只能退守单纯化疗方案。事实上，抗血管生成类靶向药物是这类人群极为重要的治疗抓手，其作用不依赖特定基因突变，可广泛适用于铂耐药阶段的患者。随着本土创新药研发的持续突破，新一代抗VEGF单克隆抗体恩泽舒®（注射用苏维西塔单抗）的上市，为无BRCA突变的铂耐药卵巢癌人群带来了疗效更确切、适用更广泛的靶向治疗新选择。 认知破局：无突变并非靶向治疗的终点 很多患者对卵巢癌靶向治疗的认知，往往局限于与基因突变紧密相关的药物品类。实际上，抗血管生成靶向治疗是卵巢癌全程管理中不可或缺的重要组成部分，其作用机制不依赖BRCA等特定基因状态，无论患者是否存在相关基因突变，均可从中获益。 在铂耐药复发阶段，抗血管生成药物联合化疗已是核心治疗策略，但此前临床常用的同类药物多缺乏针对该人群的正式获批适应症，临床应用存在一定局限。恩泽舒作为专门获批用于铂耐药复发人群的新一代抗VEGF单克隆抗体，填补了这一领域的治疗空白，为无基因突变的患者提供了合规且高效的靶向治疗方案。 机制焕新：差异化设计铸就抗血管新范式 恩泽舒 ® 是一款新型人源化抗血管内皮生长因子（VEGF）单克隆抗体，依托先进的兔源单抗打造而成，在作用机制上与现有同类药物形成了本质区别。其通过精准靶向血管内皮生长因子 A（VEGF-A），差异化分子表位设计精准阻断 VEGF 通路，从而抑制肿瘤新生血管的生成，促使已形成的肿瘤血管退化，切断肿瘤细胞赖以生存的氧气和营养供应，同时还能协同增强化疗药物在肿瘤组织中的渗透与作用效果。 独特的表位结合特性是其核心差异化所在，与现有同类药物作用于VEGF的不同位点，从分子结构层面实现了机制创新。这一设计不仅带来了更强的体外通路抑制活性，也为既往接受过同类抗血管生成药物治疗的患者，保留了后续治疗的获益空间。 循证为基：全人群获益的扎实临床证据 作为完全基于中国患者人群开展临床研究的创新药物，恩泽舒的疗效拥有高级别随机对照研究数据支撑。关键III期临床研究结果显示，其联合化疗可显著延缓疾病进展，疾病进展或死亡风险降低54%，同时实现了总生存期的显著获益，中位总生存期达15.3个月，死亡风险降低23%，24个月生存率提升超10个百分点，为患者带来了明确的长期生存收益。 尤为值得关注的是，该研究无需患者提前进行基因检测筛选，入组人群覆盖了广泛的铂耐药复发患者，其中包含近半数既往接受过贝伐珠单抗和/或PARP抑制剂治疗的难治人群。亚组分析证实，无论患者是否存在基因突变、无论既往是否使用过同类药物，均可从联合治疗中获得显著获益。恩泽舒纳入国内三大权威指南，获得高级推荐，其临床价值已得到学术领域的广泛认可。 规范施治：清晰可循的标准化给药方案 恩泽舒通用名称为注射用苏维西塔单抗，具体用法用量如下： 推荐剂量：1.5 mg/kg，每2周静脉输注给药一次。需与化疗联用，化疗方案（紫杉醇、多柔比星脂质体或拓扑替康）的用法用量请参考其各自说明书。 输注时间：首次输注时间不少于90分钟；若耐受良好，第二次输注不少于60分钟；后续输注可缩短至不少于30分钟。若出现输液相关反应，需延长输注时间。 疗程：治疗应持续直至疾病进展或出现不可耐受的毒性。 价值兼顾：安全可控与经济可及并行 安全性层面，恩泽舒的整体不良反应谱与临床已熟知的抗VEGF类药物保持一致，常见不良反应包括中性粒细胞计数降低、白细胞计数降低、蛋白尿、高血压等，无预期外的新发安全信号。临床医生已具备成熟的同类药物不良反应管理经验，整体毒性可控可管理，患者耐受度良好。 在治疗可及性方面，该药单支定价为2218元，且支持医保报销，大幅降低了患者的自付治疗成本。相较于其他需基因检测、价格高昂的靶向药物，恩泽舒无需前置检测、适用人群广、医保可覆盖，是无BRCA突变的铂耐药卵巢癌患者兼顾疗效与经济负担的务实优选。 对于不存在BRCA突变的铂耐药复发性卵巢癌患者而言，靶向治疗并非无路可走。以恩泽舒为代表的新一代抗血管生成靶向药物，凭借不依赖基因突变的作用机制、扎实的循证医学证据、广泛的人群适用性与良好的经济可及性，正在成为这一人群的核心治疗选择，为更多患者带去延长生存、改善生活质量的希望。返回搜狐，查看更多