The U.S. Food and Drug Administration declined to approve Summit Therapeutics’ lung cancer drug ivonescimab on November 15, 2026, Reuters reported. The late-stage trial’s primary analysis did not demonstrate a statistically significant improvement in overall survival. Source
Summit sought approval for a subtype of advanced non-small cell lung cancer after prior treatment with medicines targeting EGFR, a protein that can drive tumor growth, according to Bloomberg. Source
What the 48% result measures
In the late-stage study, ivonescimab combined with chemotherapy reduced the risk of disease progression or death by 48% compared with chemotherapy alone. But the primary analysis did not demonstrate a statistically significant improvement in overall survival, which measures how long patients live after starting treatment. Source
The 48% figure concerns progression or death together; it does not establish a 48% reduction in mortality alone or a 48% increase in lifespan. Source
In a complete response letter, the FDA concluded that the progression-free survival benefit alone did not support a favorable benefit-risk profile for this application, Reuters reported. Source
Summit points to longer follow-up
Summit argues that longer follow-up supports ivonescimab’s benefit, according to Reuters. The company submitted updated survival data to the FDA that it said showed consistent improvement across Asian and Western patients. Source
The decision is also a setback for Akeso, the Chinese company that developed ivonescimab and markets it in China, according to Bloomberg. Summit acquired rights in the United States, Canada, Europe and Japan in 2022 through a deal valued at up to $5 billion, Reuters reported. SourceSource
Reuters’ report did not specify a resubmission timetable or what additional evidence the FDA would require. Source
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