The FDA issued a complete response letter declining to approve ivonescimab for previously treated, EGFR-mutated non-small cell lung cancer, citing a lack of statistically significant overall survival benefit.
The FDA has declined to approve Summit Therapeutics' ivonescimab for patients with previously treated, EGFR-mutated non-small cell lung cancer, issuing a complete response letter to the company.
The FDA determined that Summit has not established substantial evidence of effectiveness because the therapy did not show a statistically significant overall survival (OS) benefit. According to Summit, the agency concluded that a progression-free survival (PFS) benefit "in the absence of a statistically significant OS benefit does not support a positive benefit-risk profile in support of approval."
The application was based on the Phase 3 HARMONi trial. In the global trial, ivonescimab plus platinum-based chemotherapy reduced the risk of disease progression or death by 48% compared to chemotherapy alone. However, OS showed only a positive trend at the prespecified primary analysis and did not reach statistical significance, with a hazard ratio of 0.79. Subsequent analyses produced OS hazard ratios of 0.78 and 0.76.
Robert Duggan, chairman and co-CEO of Summit, said in a release: "We are disappointed for patients and their families awaiting additional treatment options in this setting." He also said: "With five positive Phase III studies between Summit and Akeso, nothing changes with respect to our ever-growing belief in the opportunity for ivonescimab and our determination to advance ivonescimab's development."
Ivonescimab was developed by Akeso and partnered with Summit under a 2022 licensing agreement. It received its first approval in China in May 2024 for the same indication. The China-only Harmoni-A trial met its OS endpoint at the final analysis with a 26% death risk reduction.
The rejection narrows ivonescimab's potential first-mover advantage as several companies advance their own PD-(L)1xVEGF bispecifics into global phase 3 trials, including Pfizer's tivunatamig, BioNTech and Bristol Myers Squibb's pumitamig, Merck's MK-2010, and AbbVie's ABBV-1480.
The decision blocks ivonescimab's U.S. entry for this indication after it became available in China in 2024. Had it been approved, it would have marked the first approval for a PD-1xVEGF bispecific antibody in the U.S. market. Summit said it will continue its expansive clinical development program, including the upcoming Harmoni-3 trial readout in first-line NSCLC.
Sources
This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.
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