NMPA Accepts Akeso's sBLA for Ivonescimab in 1L PD-L1 Positive NSCLC

HONG KONG, July 29, 2024 -- Akeso (9926.HK) has announced that the supplemental biologics license application (sBLA) for its unique PD-1/VEGF bispecific antibody drug, ivonescimab Injection, as a monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC), has been accepted by the China National Medical Products Administration (NMPA).

Ivonescimab is the world's first bispecific antibody drug approved for the "tumor immunotherapy + anti-angiogenesis" mechanism. This indication for first-line monotherapy treatment of PD-L1 positive NSCLC is Ivonescimab's second approved use, following its prior approval for treating EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy. The drug is anticipated to serve as a new standard of care for both first-line and second-line lung cancer therapies.

The new application for ivonescimab is based on the HARMONi-2 (AK112-303) study. The Independent Data Monitoring Committee (IDMC) conducted an interim analysis of this study, revealing highly positive results. In the intent-to-treat (ITT) population, ivonescimab monotherapy significantly extended progression-free survival (PFS) compared to pembrolizumab monotherapy, with a hazard ratio (HR) that was notably better than anticipated.

Professor Zhou Caicun, the principal investigator of the HARMONi-2 study and director of the Oncology Department at East Hospital Affiliated To Tongji University, expressed his optimism about ivonescimab becoming the new standard treatment for first-line lung cancer, providing a superior chemotherapy-free option for patients. He highlighted the study's success in demonstrating the value of ivonescimab's dual anti-tumor mechanism of tumor immunotherapy and anti-angiogenesis.

Dr. Michelle Xia, Founder, Chairwoman, President, and CEO of Akeso, emphasized the significance of ivonescimab achieving this milestone in first-line lung cancer therapy soon after its approval for second-line treatment. She expressed gratitude for the dedication of Akeso's team, the experts' meticulous contributions, and all involved in the project. According to Dr. Xia, ivonescimab's approvals for second-line lung cancer therapy and its potential as a superior, chemotherapy-free new standard for first-line treatment address a critical unmet need in global lung cancer immunotherapy with bispecific antibodies.

Dr. Xia also underscored that the HARMONi-2 study highlights ivonescimab's superior efficacy and safety, supporting its potential as a cornerstone product in tumor immunotherapy. The drug's broad clinical development value and market prospects, especially in combination with ADC drugs or other novel anti-cancer therapies, were emphasized. Akeso looks forward to sharing ivonescimab's robust clinical research data with global regulatory agencies to achieve worldwide approval and provide effective solutions to patients globally.

Ivonescimab, also known as SMT112 in Summit's license territories (the United States, Canada, Europe, and Japan) and as AK112 in China and Australia, is a novel bispecific antibody that combines the effects of immunotherapy via PD-1 blockade with the anti-angiogenesis effects of VEGF blockade into a single molecule. Its unique tetravalent structure enables higher binding affinity to both PD-1 and VEGF in tumor tissues, potentially enhancing its efficacy and safety profile.

Discovered by Akeso Inc., ivonescimab is currently undergoing multiple Phase III clinical trials. Over 1,600 patients have received ivonescimab in clinical studies worldwide. Summit has initiated its clinical development of ivonescimab in NSCLC, with two Phase III trials, HARMONi and HARMONi-3, beginning enrollment in 2023. Although not yet approved by regulatory authorities in Summit's licensed territories, ivonescimab received marketing authorization in China in May 2024.

Akeso, founded in 2012, is a leading biopharmaceutical company focused on innovative solutions in the fields of cancer, autoimmune diseases, inflammation, metabolic diseases, and other major health concerns. The company has a comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody). Akeso's robust pipeline includes over 50 innovative assets, with 19 drug candidates in the clinical stage, including 8 multispecific antibodies. The company has successfully commercialized three innovative biological drugs and has multiple marketing applications for new drug indications. Akeso aims to integrate superior global resources, develop first-in-class and best-in-class new drugs, and provide affordable therapeutic antibodies for patients worldwide.

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