Ivonescimab shows survival benefit in lung cancer study

Summit Therapeutics Inc. (NASDAQ: SMMT) announced that partner Akeso Inc. (HKEX: 9926.HK) published results from a Phase III study showing ivonescimab plus chemotherapy achieved a statistically significant overall survival benefit in patients with EGFR-mutated non-small cell lung cancer.

The HARMONi-A study, conducted in China, demonstrated a hazard ratio of 0.74 for overall survival when comparing ivonescimab plus chemotherapy to chemotherapy alone. Median overall survival was 16.8 months for patients receiving the combination treatment versus 14.1 months for those receiving chemotherapy alone.

The study enrolled patients with locally advanced or metastatic non-squamous NSCLC who had progressed after treatment with an EGFR tyrosine kinase inhibitor. Results were presented at the Society for Immunotherapy of Cancer annual meeting.

The analysis included a data cutoff of April 2025 with a median follow-up of 32.5 months. Akeso previously received approval from China's National Medical Products Administration for ivonescimab plus chemotherapy in this patient population in May 2024 based on progression-free survival data.

Safety data showed 18 patients discontinued ivonescimab plus chemotherapy due to treatment-related adverse events compared to 10 patients who discontinued chemotherapy alone. One patient in each treatment arm died from treatment-related adverse events.

Ivonescimab is a bispecific antibody that targets both PD-1 and VEGF pathways. The drug has been tested in multiple Phase III studies, with over 40,000 patients treated in clinical or commercial settings in China according to the companies.

Summit is conducting its own multiregional Phase III study called HARMONi, which previously showed a statistically significant progression-free survival benefit but did not achieve statistical significance for overall survival in the primary analysis.

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