Summit Therapeutics (SMMT) said Friday that its late-stage study of ivonescimab plus chemotherapy met the progression-free survival primary endpoint in patients with EGFR-mutated non-small cell lung cancer.
The treatment reduced the risk of disease progression or death by 48% compared to chemotherapy alone, with consistent results seen across Asian and non-Asian subgroups, Summit said.
A positive trend was observed in overall survival, though the data did not meet statistical significance, the company said.
Adverse events in the ivonescimab arm were in line with expectations and manageable, Summit said, with no new safety issues identified.
The company said it plans to file a Biologics License Application in the US, pending further evaluation and discussions with the US Food and Drug Administration.
Shares of the company were down 15% in recent Friday premarket activity.
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