FDA issues complete response letter for Summit Therapeutics’ ivonescimab BLA
Summit Therapeutics received a Complete Response Letter from the U.S. Food and Drug Administration for its Biologics License Application for ivonescimab combined with platinum chemotherapy in EGFR‑mutated non‑small cell lung cancer. The agency said the submission lacked statistically significant overall‑survival data, even though the Phase III HARMONi trial met its progression‑free survival endpoint. Summit said it will keep developing ivonescimab in other cancer indications.
Why it matters
The CRL means the drug cannot be marketed in the United States until additional data demonstrate a survival benefit, delaying potential revenue from this indication. Summit will need to allocate resources to further trials rather than commercial launch, which may affect short‑term earnings expectations.
Key facts
- 1The FDA issued a Complete Response Letter for the BLA of ivonescimab plus platinum chemotherapy in locally advanced or metastatic NSCLC after prior EGFR TKI therapy. finance.yahoo.com
- 2The agency required statistically significant overall‑survival improvement, which the submission did not provide. finance.yahoo.com
- 3In the HARMONi Phase III trial, the drug achieved a statistically significant progression‑free survival benefit. finance.yahoo.com
- 4Overall‑survival data showed a positive trend but did not reach statistical significance. rttnews.com
- 5A post‑hoc analysis reported a hazard ratio of 0.76 for overall survival across the full population and sub‑groups. rttnews.com
- 6Summit’s stock closed at $14.15, down 6.14%, before edging up to $14.17 after hours. rttnews.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.