Akeso Inc. announced that the Late-Breaking Abstract (LBA) from the registrational Phase III clinical study (AK112-306/HARMONi-6 study) of ivonescimab, a globally first-in-class bispecific antibody targeting PD-1 and VEGF, will be presented at the 2025 European Society for Medical Oncology (ESMO) Annual Congress. The study’s principal investigator, Professor Lu Shun, Director of the Department of Oncology at Shanghai Chest Hospital, will present the results from this pivotal study. Additionally, the final results of the Phase III clinical study (COMPASSION-15/AK104-302 study) of cadonilimab in combination with oxaliplatin and capecitabine as first-line treatment for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, have been accepted for a Mini Oral Session at ESMO.
The upcoming detailed results from the HARMONi-6 study, to be presented at ESMO 2025, will provide a comprehensive overview of the exceptional efficacy and favorable safety profile of ivonescimab in combination with chemotherapy for the treatment of first line advanced squamous NSCLC. Notably, it is the second Phase III head-to-head trial where ivonescimab has outperformed a PD-1 inhibitor-based regimen, reinforcing its breakthrough clinical value. The promising results thus far affirm that ivonescimab provides significant advancements in clinical treatment for NSCLC, whether compared to PD-1 monotherapy, PD-1 plus chemotherapy, or VEGF-targeted therapies.
In April 2025, Akeso announced that the topline results from the registrational Phase III study, HARMONi-6, met its primary endpoint of progression-free survival (PFS), as confirmed by the Independent Data Monitoring Committee (IDMC). On July 28, 2025, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) accepted the supplemental New Drug Application (sNDA) for ivonescimab in combined with chemotherapy as a first-line treatment for advanced sq-NSCLC. Cadonilimab (Cado) plus chemotherapy (chemo) versus chemotherapy as first-line (1L) treatment for advanced gastric cancer.
Speaker: Professor Shen Lin, Peking University Cancer Hospital. Presentation Format: 2098MO. Presentation Time: 10:45-10:50 AM (CEST), Saturday, 18 October 2025 The final results of the COMPASSION-15 study, to be presented atESMO 2025, will further validate the groundbreaking clinical value of the cadonilimab-based regimen, reinforcing its potential as a transformative therapeutic option for advanced gastric cancer.
Due to the positive clinical results, cadonilimab received approval from the NMPA in September 2024 for the first-line treatment of advanced gastric cancer. R risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R. China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; inherent in new product development, including obtaining regulatory approval; Through efficient and breakthrough breakthrough product development, including obtaining regulatory approved; Through efficient and breakthrough clinical value of the Cadonilimab and a combination with chemotherapy for advanced gastric cancer.