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Summit Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA Seeking Approval for Ivonescimab in Combination with Chemotherapy in 2L+ Treatment of Patients with EGFRm NSCLC
Significant Unmet Need Remains in this Setting Over 14,000 Patients are Eligible for 2L+ Treatment in This Setting in the United States Each Year Summit
About this update from Summit Therapeutics Inc.
[{"type":"text","content":"\nSignificant Unmet Need Remains in this Setting\n\n\nOver 14,000 Patients are Eligible for 2L+ Treatment in This Setting in the United States Each Year\n\n\nSummit Enters 2026 with Approximately $710 Million in Cash\n\n\n MIAMI--(BUSINESS WIRE)--\nSummit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for ivonescimab, the novel, first-in-class investigational bispecific antibody, in combination with chemotherapy in second-line or later treatment of patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The BLA submission was based on the overall results of the global Phase III HARMONi trial. The BLA was submitted during the fourth quarter of 2025.\n\n\n“This BLA submission, the first for ivonescimab, marks a critical milestone for Summit, our global clinical development plan, and the many patients with EGFRm NSCLC in need of better therapeutics options,” stated Robert W. Duggan and Dr. Maky Zanganeh, Co-Chief Executive Officers of Summit. “As we continue to support and expand ivonescimab’s rapid development via our growing set of global Phase III trials and clinical collaborations, we look forward to the potential first U.S. approval for ivonescimab in this difficult to treat setting.”\n\n\nHARMONi evaluated ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic NSCLC who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI). This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials in showing either a progression-free survival (PFS) or overall survival (OS) benefit, the two primary endpoints of this clinical study.\n\n\nBased upon standard review timelines, if the application is accepted as submitted, we anticipate a decision from the agency by the fourth quarter of 2026.\n\n\nUpdate Regarding Current Financial Position\n\n\nAs of December 31, 2025, the company’s preliminary unaudited balance of cash, cash equivalents, and short-term investments...