FDA Declines to Approve Summit's Lung Cancer Drug Ivonescimab Over Overall Survival Data
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to Summit Therapeutics, declining to approve the Biologics License Application for its lung cancer drug ivonescimab in combination with platinum-containing chemotherapy in its present form. Summit announced the decision on November 15. The application covered patients with locally advanced or metastatic non-small cell lung cancer who had previously received an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.
In the letter, the FDA determined that substantial evidence of effectiveness is not established in the absence of a statistically significant improvement in overall survival, and that a progression-free survival benefit alone does not support a positive benefit-risk profile. The HARMONi Phase III trial supporting the application met its primary progression-free survival endpoint, but the primary analysis of overall survival did not reach statistical significance despite a positive trend.
Summit said post-hoc analyses of longer-term follow-up showed a consistent overall survival benefit across Western patients, Asian patients and the full population, with a hazard ratio of 0.76. The drug showed an acceptable safety profile with manageable adverse events, comparable discontinuation rates between the treatment arms and low rates of treatment-related death. Robert Duggan, Summit's chairman and co-chief executive, said in the statement that the company was disappointed for patients and their families awaiting additional treatment options.
Ivonescimab is a PD-1 x VEGF bispecific antibody that was first approved in China in May 2024 but remains unapproved in the United States and Europe, and no PD-1 x VEGF bispecific antibody is currently approved in the U.S. Summit said it will continue developing the drug across multiple other indications, including colorectal cancer, urothelial carcinoma and renal cell carcinoma, with Phase III trials such as HARMONi-3 and HARMONi-7 under way.
Source: Summit Therapeutics
Published by GSM · USA (original Chinese edition)
Photo: 图：美国食品药品监管局（FDA）总部大楼入口。FDA 官方图，公共领域，经 Wikimedia Commons。 / Photo: Entrance of the U.S. Food and Drug Administration headquarters. FDA official photo, public domain, via Wikimedia Commons.
