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2025/10/30
First Dual-Positive Immunotherapy with PFS and OS Benefit in EGFR+ NSCLC After EGFR-TKI Progression: Ivonescimab Final OS Analysis from HARMONi-A to Be Presented at SITC 2025

HONG KONG, Oct. 29, 2025--Akeso (9926.HK) is excited to announce that the significant results from the final overall survival analysis of the Phase III HARMONi-A study, which evaluates the first-in-class bispecific antibody ivonescimab (PD-1/VEGF bispecific antibody) combined with chemotherapy for EGFR-mutated, non-squamous non-small cell lung cancer (NSCLC) patients after EGFR-TKI progression, have been selected as a Late-Breaking Abstract at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (2025 SITC).

Title: Final Overall Survival Analysis of HARMONi-A Study Comparing Ivonescimab Plus Chemotherapy to Chemotherapy Alone in Patients With EGFR+ NSCLC Progressed on EGFR-TKI Treatment

• Abstract Number: 1348

• Session: Clinical Oral Abstract Session 104

• Date/Time: Friday, November 7, 2025, 11:30 AM ET 

The HARMONi-A study is the first Phase III trial of an immunotherapy for EGFR-TKI-resistant, EGFR-mutated non-squamous NSCLC to show statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS). This marks ivonescimab’s first final OS analysis in a Phase III trial and confirms its groundbreaking survival benefit for non-squamous NSCLC patients that progressed after EGFR-TKI therapy. 

Based on the positive clinical data from the HARMONi-A study, ivonescimab received approval from the China National Medical Products Administration in May 2024 for this indication. In November 2024, Akeso announced that ivonescimab was successfully added to China's National Reimbursement Drug List, effective January 1, 2025, ensuring widespread patient access to this life-saving treatment. 

Additionally, Akeso's global partner, Summit Therapeutics, announced in October 2025 that it plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025, seeking approval for ivonescimab in combination with chemotherapy for the treatment of EGFR-mutant, third-generation EGFR-TKI-resistant, non-squamous NSCLC.


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