Summit Therapeutics Inc. announced on October 3, 2024, the completion of enrollment in its HARMONi clinical trial, a multi-regional Phase III study evaluating ivonescimab plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). These patients had previously progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor.
The U.S. Food and Drug Administration (FDA) also granted Fast Track designation for ivonescimab in combination with platinum-based chemotherapy for this patient population. This designation is intended to facilitate the development and expedite the review of drugs for serious conditions with unmet medical needs, potentially leading to earlier drug approval.
Topline data from the HARMONi trial is expected in mid-2025. This milestone follows the marketing authorization received by Summit's partner, Akeso, Inc., from the NMPA in China in May 2024 for a similar patient population based on the HARMONi-A study.
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