依沃西单抗联合化疗在一线治疗鳞状非小细胞肺癌（sq-NSCLC）中显示出统计学显著且强烈阳性的结果，对比替雷利珠单抗联合化疗-动脉网

Ivonescimab in Combination with Chemotherapy Demonstrates Statistically Significant and Strongly Positive Results in First-Line Treatment of Squamous Non-Small Cell Lung Cancer (sq-NSCLC) vs. Tislelizumab in Combination with Chemotherapy

CISION 等信源发布 2025-04-23 08:16

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可切换为仅中文

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HONG KONG

香港

，

April 22, 2025

2025年4月22日

/PRNewswire/ -- Akeso, Inc. (9926.HK) ('Akeso' or the 'Company') is both pleased and honored to announce that its global first-in-class PD-1/VEGF bispecific antibody, ivonescimab, in combination with chemotherapy, has demonstrated strongly positive results in the Phase III clinical trial (AK112-306/HARMONi-6) for first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC).

/PRNewswire/ -- 康方生物（9926.HK）（“康方”或“公司”）欣然且荣幸地宣布，其全球首创的PD-1/VEGF双特异性抗体依沃西单抗联合化疗，在针对一线治疗晚期鳞状非小细胞肺癌（sq-NSCLC）的III期临床试验（AK112-306/HARMONi-6）中取得了极为积极的结果。

The Independent Data Monitoring Committee (IDMC) declared that the study had met its primary endpoint of progression-free survival (PFS) at the first pre-specified interim analysis. The results of HARMONi-6 study are both statistically significant and clinically meaningful..

独立数据监测委员会 (IDMC) 宣布，该研究在第一次预先设定的中期分析时已达到其主要终点——无进展生存期 (PFS)。HARMONi-6 研究的结果在统计学上显著且在临床上具有重要意义。

Detailed results from the HARMONi-6 study will be presented at an upcoming medical conference later this year.

今年晚些时候在即将召开的医学会议上将展示HARMONi-6研究的详细结果。

Data from the HARMONi-6 study show that, in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS)

HARMONi-6研究的数据表明，在意向治疗（ITT）人群中，依沃西单抗联合化疗在无进展生存期（PFS）方面明显优于替雷利珠单抗联合化疗。

The ivonescimab combination showed clinically meaningful PFS benefits in both PD-L1-positive and PD-L1-negative populations

依沃西单抗组合在PD-L1阳性和PD-L1阴性人群中均显示出具有临床意义的无进展生存期（PFS）益处。

The trial enrolled a total of 532 patients, approximately 63% of whom had centrally located squamous cell carcinoma, a distribution consistent with real-world patient populations

该试验共纳入了532名患者，其中约63%的患者患有中心型鳞状细胞癌，这一分布与真实世界的患者群体一致。

Ivonescimab demonstrated a favorable safety profile, with no new safety signals identified. The incidence of treatment related serious adverse events and the incidence of bleeding events of grade 3 or higher were comparable to those of the control group

伊沃内西单抗表现出良好的安全性，未发现新的安全信号。治疗相关的严重不良事件发生率以及3级或以上出血事件的发生率与对照组相当。

The HARMONi-6 study is ivonescimab's third Phase III clinical trial with positive results in lung cancer, highlighting that treatment with ivonescimab can overcome the limitations of bevacizumab in treating squamous-NSCLC.

HARMONi-6研究是依沃西单抗在肺癌领域取得积极结果的第三项III期临床试验，凸显了依沃西单抗治疗可以克服贝伐珠单抗在治疗鳞状非小细胞肺癌方面的局限性。

The HARMONi-6 study is also ivonescimab's second Phase III clinical trial with positive results in lung cancer in head-to-head comparisons vs. PD-1 inhibitors, further establishing ivonescimab as a comprehensive treatment option for both first-line and later-line NSCLC. This result further positions ivonescimab to improve upon and replace the current standard of care for the treatment of NSCLC.

HARMONi-6 研究也是伊莫尼单抗第二个在肺癌领域与PD-1抑制剂进行头对头比较并获得积极结果的III期临床试验，进一步确立了伊莫尼单抗作为一线和后线非小细胞肺癌全面治疗方案的地位。这一结果使伊莫尼单抗有望改进并取代当前非小细胞肺癌的标准治疗方案。

The study was conducted at 66 clinical research centers across .

该研究在66个临床研究中心开展。

China

中国

。

Professor Lu Shun, Director of

陆顺教授，主任

Shanghai

上海

lung cancer, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine and principal investigator of the AK112-306 / HARMONi-6 study, commented:

上海市交通大学医学院附属上海胸科医院肺癌首席研究员、AK112-306/HARMONi-6 研究项目负责人评论道：

'It is a great honor for us to witness ivonescimab once again successfully challenge the optimal standard of care. This breakthrough not only advances the treatment of non-small cell lung cancer but also marks a significant milestone in global oncology immunotherapy.'

“我们很荣幸再次见证了伊沃西单抗成功挑战了最佳治疗标准。这一突破不仅推进了非小细胞肺癌的治疗，也标志着全球肿瘤免疫治疗领域的一个重要里程碑。”

'The interim analysis results from the HARMONi-6 study show that ivonescimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) compared to tislelizumab with chemotherapy. In patients with up to 63% central squamous carcinoma, ivonescimab demonstrated a safety profile comparable to the control group.

HARMONi-6研究的中期分析结果显示，与替雷利珠单抗联合化疗相比，伊伏西单抗联合化疗显著延长了无进展生存期（PFS）。在高达63%的中央鳞状细胞癌患者中，伊伏西单抗显示出与对照组相当的安全性。

This highlights its potential to overcome the limitations of bevacizumab in treating squamous non-small cell lung cancer, ultimately enhancing the clinical benefits of immunotherapy for NSCLC. With its combined immune and antiangiogenic mechanisms, ivonescimab offers a promising new treatment option for patients with advanced squamous carcinoma.'.

这突显了其克服贝伐单抗在治疗鳞状非小细胞肺癌中的局限性的潜力，最终增强了免疫疗法对非小细胞肺癌的临床益处。凭借其结合免疫和抗血管生成机制，依沃西单抗为晚期鳞状细胞癌患者提供了一个有前景的新治疗选择。

Professor Lu added,

陆教授补充道，

'Ivonescimab has gained widespread recognition for treating EGFR-TKI-resistant, advanced nsq-NSCLC since its approval in

伊沃内西单抗自获批以来，已广泛应用于治疗EGFR-TKI耐药的晚期非鳞状非小细胞肺癌（nsq-NSCLC）。

China

中国

nearly a year ago. The HARMONi-2 study showed strong positive results for PD-L1-positive squamous and non-squamous NSCLC in first-line treatment. Additionally, the recent HARMONi-6 study demonstrated significant positive outcomes in first-line squamous NSCLC, further confirming ivonescimab's exceptional efficacy in both squamous and non-squamous cancers.

近一年前，HARMONi-2 研究显示了在一线治疗中 PD-L1 阳性鳞状和非鳞状非小细胞肺癌的强劲积极结果。此外，最近的 HARMONi-6 研究在一线治疗鳞状非小细胞肺癌中也显示出显著的积极结果，进一步证实了 ivonescimab 在鳞状和非鳞状癌症中的卓越疗效。

This positions ivonescimab as a new standard of care for the treatment of these types of cancer. I am confident and excited about its potential in global Phase III trials and its ability to positively reshape the global oncology landscape with a Chinese solution.'.

这使得伊伏西单抗成为治疗这类癌症的新标准。我对它在全球III期试验中的潜力及其以中国解决方案积极重塑全球肿瘤学领域的可能性充满信心和期待。"

Dr.

博士

Xia Yu

夏雨

, Founder, Chairwoman, President, and CEO of Akeso, said:

康方生物创始人、董事长、总裁兼首席执行官表示：

'Today, we are incredibly excited to announce the third significant positive result for ivonescimab in a Phase III study. PD-1 combined with chemotherapy remains the global standard of care for first-line treatment of NSCLC. Ivonescimab has once again demonstrated its breakthrough clinical value and market competitiveness as a next-generation cancer therapy through compelling clinical data.

“今天，我们非常激动地宣布伊伏西单抗在III期研究中取得了第三个显著的阳性结果。PD-1联合化疗仍然是全球非小细胞肺癌一线治疗的标准疗法。伊伏西单抗再次通过令人信服的临床数据展示了其作为下一代癌症疗法的突破性临床价值和市场竞争力。

We sincerely thank all the investigators, participants, and patients who have contributed to this clinical study.'.

我们衷心感谢所有为这项临床研究做出贡献的研究人员、参与者和患者。

Dr. Xia continued,

夏博士继续说道，

'Beyond its demonstrated superior efficacy and safety in non-small cell lung cancer, ivonescimab is currently being tested in multiple Phase II and III trials across other cancer types, establishing a clear leadership in both improving patients' lives and addressing critical unmet need across multiple cancer types.

“除了在非小细胞肺癌中已证明的优越疗效和安全性外，伊沃西单抗目前还在其他癌症类型的多项 II 期和 III 期试验中进行测试，在改善患者生活和满足多种癌症类型的关键未满足需求方面确立了明确的领先地位。”

The success of the HARMONi-6 study validates our very high confidence in continuing to integrate global resources and advancing ivonescimab's role as a next-gen immunotherapy. We look forward to working with our partner Summit on expanding global access to ivonescimab. We are impressed by and also appreciative of their progress in developing ivonescimab in the US, .

HARMONi-6研究的成功验证了我们继续整合全球资源、推动伊沃西单抗作为下一代免疫疗法的极高信心。我们期待与合作伙伴Summit共同努力，扩大伊沃西单抗的全球可及性。他们在美国开发伊沃西单抗的进展给我们留下了深刻印象，我们也对此表示赞赏。

Europe

欧洲

, and Japan. We are committed to improving the standard of care, changing treatment approaches, and offering safer, more unwaveringly effective solutions for patients worldwide.'

，以及日本。我们致力于提高护理标准，改变治疗方法，为全世界的患者提供更安全、更坚定不移的有效解决方案。”

About Akeso

关于阿科索

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.

康方生物（港交所代码：9926.HK）是一家领先的生物制药公司，致力于研究、开发、生产和商业化全球首创或同类最佳的创新生物药物。公司成立于2012年，构建了以全方位端到端药物开发平台（ACE平台）和双特异性抗体药物开发技术（Tetrabody）为核心的独特一体化研发创新体系，以及符合GMP标准的生产体系和具有先进运营模式的商业化体系，逐步发展成为一家专注于创新解决方案、具备全球竞争力的生物制药企业。

With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs.

通过完全集成的多功能平台，康方生物内部正在开发一条强大的超过50个创新资产的研发管线，覆盖癌症、自身免疫疾病、炎症、代谢疾病和其他主要疾病领域。其中，24个候选药物已进入临床试验阶段（包括15个双特异性/多特异性抗体和双特异性ADC）。

Additionally, 7 new drugs are commercially available, and 4 new drugs with 4 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise..

此外，7个新药已上市销售，4个新药4个新适应症处于审评审批阶段。通过高效及突破性的研发创新，康方生物始终整合全球优质资源，开发first-in-class和best-in-class新药，为全球患者提供可负担的抗体药物，并不断创造更多商业价值与社会价值，成为全球领先的生物制药企业。

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