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

HONG KONG, April 22, 2025 /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). 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.

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

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

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.

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. The study was conducted at 66 clinical research centers across China.

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

"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."

"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. 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."

Professor Lu added,

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

Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso, said:

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

Dr. Xia continued,

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

About Akeso
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. 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. 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.

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SOURCE Akeso, Inc.