Portfolio News
·The HARMONi-A study is the first Phase III trial of an immunotherapy for EGFR-TKI-resistant, EGFR-mutated non-squamous NSCLCto show statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS)
·With a median follow-up of 32.5 months, the ivonescimab combination regimen showed a median OS of 16.8 months, versus 14.1 months for chemotherapy (OS HR=0.74, P=0.019)
·The OS benefit of the ivonescimab combination regimen was consistent across all subgroups, showing significant improvement regardless of the presence of brain metastases or EGFR mutations (19Del and L858R)
·During the 32.5-month follow-up period, the ivonescimab combination regimen demonstrated excellent safety
·These are the final and only formal OS analysis results from the HARMONi-A study
·Ivonescimab was approved for market launch in China in May 2024 and was added to the National Reimbursement Drug List (NRDL) in November 2024
HONG KONG, Nov. 07, 2025 -- Akeso, Inc. (HKEX: 9926.HK) is excited to announce that the final Overall Survival (OS) analysis results from the HARMONi-A study, a Phase III study evaluating ivonescimab combined with chemotherapy for the treatment of EGFR-mutated non-squamous non-small cell lung cancer (nsq-NSCLC) following EGFR-TKI progression, were selected as a "Late-Breaking Abstract" (LBA) for the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held in National Harbor, Maryland, USA. Professor Xiuning Le from MD Anderson Cancer Center presented these findings to a global audience during an oral presentation session.
HARMONi-A is the first global Phase III clinical trial of an immunotherapy in the EGFR-TKI resistant, EGFR-mutated nsq-NSCLC setting to demonstrate clinically meaningful and statistically significant benefits in both Progression-Free Survival (PFS) and Overall Survival (OS). This final OS analysis, the first from a Phase III trial of ivonescimab, confirms the breakthrough value of ivonescimab-based therapy in improving both PFS and OS. Historically, cancer immunotherapies have largely failed to demonstrate significant breakthroughs in this specific indication. Prior Phase III trials involving other regimens—such as PD-1 inhibitors combined with chemotherapy or immunotherapies combined with anti-angiogenic therapy, failed to show significant OS benefits. The significant positive outcomes in both PFS and OS in the HARMONi-A study underscore the substantial clinical benefit improvement of ivonescimab over PD-1 inhibitors.
Previously, the HARMONi-A study had already met its primary endpoint, demonstrating a statistically significant improvement in PFS at the interim analysis (PFS HR 0.46, P < 0.001). Previously, during the regulatory review for the approval of ivonescimab in first-line PD-L1-positive NSCLC in China, a descriptive analysis of OS from the HARMONi-A study was conducted in May 2024 at the request of the regulatory authorities. The final OS analysis results presented at SITC 2025 represent the final and only pre-specified formal OS analysis for the HARMONi-A study, performed as a sequential test according to the pre-specified statistical analysis plan (SAP).
The final OS analysis, with a median follow-up period of 32.5 months, showed that the ivonescimab plus chemotherapy regimen provided a clinically meaningful and statistically significant improvement in OS compared to chemotherapy alone:
·The median OS was 16.8 months in the ivonescimab treatment group compared to 14.1 months in the control group (OSHR=0.74, P=0.019), achieving statistical significance.
·The OS benefit increased with extended follow-up.
·The ivonescimab combination regimen consistently demonstrated OS benefit over the control group across all subgroups:
·In patients with brain metastases, OS HR=0.61;
·In patients without brain metastases, OS HR=0.77;
·In patients with EGFR 19Del mutations, OS HR=0.83;
·In patients with EGFR L858R mutations, OS HR=0.60.
With a median follow-up of 32.5 months, the long-term safety profile of the ivonescimab combination therapy remained favorable, with no new safety signals identified. The incidence of common treatment-related adverse events (TRAEs) showed no significant difference between the two groups.
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, Summit Therapeutics, Akeso's global partner for ivonescimab, 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.
