FDA Rejects China-Invented Lung Cancer Drug After Trial Misses Survival Benefit
Updated
Updated · The New York Times · Nov 15
FDA Rejects China-Invented Lung Cancer Drug After Trial Misses Survival Benefit
3 articles · Updated · The New York Times · Nov 15
Summary
Summit Therapeutics said the FDA rejected ivonescimab for certain advanced lung cancer patients after the drug failed to show a statistically significant overall-survival benefit in the global trial backing its application.
The application relied on a study across the United States, Canada, Europe and Asia in previously treated patients, where ivonescimab plus chemotherapy delayed disease progression versus chemotherapy alone but did not extend lives enough for regulators.
Summit had argued slow enrollment distorted the survival readout and submitted additional longer-term analyses outside the original research plan, but those did not persuade the agency.
The setback hits a closely watched first-of-its-kind drug licensed by Summit from Akeso and tempers hopes it could challenge Keytruda, even as Chinese-developed medicines gain ground in the U.S. market.
Ivonescimab is still being tested in 17 late-stage studies worldwide, including a trial due by year-end comparing it with Keytruda in previously untreated advanced lung cancer that could support a new FDA filing.
Why did the FDA reject a groundbreaking cancer drug that already outperformed standard treatments in overseas trials?
Could strict FDA survival standards cause the US to lose the biotechnology race against rapidly advancing foreign medical innovations?
Survival Over Surrogates: FDA’s 2026 Ivonescimab Rejection Reshapes PD-1xVEGF Bispecifics and US-China Biotech Deals
Overview
On November 15, 2026, the FDA rejected Summit Therapeutics’ ivonescimab for EGFR-mutated NSCLC after the global HARMONi trial failed to show a statistically significant overall survival benefit, despite strong progression-free survival results. While Akeso had already secured approval in China based on positive survival data, the FDA prioritized its stricter standards and did not accept retrospective subgroup improvements. This decision highlights the agency’s focus on robust, multi-regional data and overall survival as the key endpoint. Meanwhile, Summit secured a $2 billion investment from AstraZeneca and continues to expand ivonescimab’s development, reflecting ongoing cross-border biotech collaboration and evolving regulatory expectations.