Summit Therapeutics Provides Update Regarding Ivonescimab Biologics License Application

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MIAMI, November 15, 2026--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for ivonescimab in combination with platinum-containing chemotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received prior…

Complete Response Letter Received from FDA for BLA Application Based on HARMONi Study

MIAMI, November 15, 2026--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for ivonescimab in combination with platinum-containing chemotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy. Ivonescimab is a novel PD-1 x VEGF bispecific antibody.

"As a cancer survivor, I understand firsthand how important it is for patients to have access to multiple treatment options, particularly when they are facing diseases with significant unmet medical needs," emphasized Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. "Behind every diagnosis is a person, a family, and a community hoping for more time, more possibilities, and a better future. I know that hope is not simply an emotion; it is the possibility that another treatment, another scientific breakthrough, or another therapeutic option may make a meaningful difference in someone's life. Every additional treatment option matters.

The CRL indicates that the BLA cannot be approved in its present form, as the FDA determined that substantial evidence of effectiveness is not established in the absence of a statistically significant overall survival (OS) improvement. The FDA indicated that the 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.

Currently, there are no FDA-approved regimens that have demonstrated a statistically significant OS benefit in this patient setting.

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