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VisitWill the FDA approve Summit Therapeutics' ivonescimab for NSCLC by December 31, 2024?
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FDA official announcements
Summit’s Lung Cancer Therapy Outperforms Merck’s Keytruda by 49% in Phase 3 NSCLC Trial
Sep 8, 2024, 03:30 PM
Summit Therapeutics has announced that its lung cancer therapy, ivonescimab, has demonstrated superior efficacy compared to Merck's Keytruda in a head-to-head Phase 3 trial. The HARMONi-2 study, presented at the World Conference on Lung Cancer 2024, revealed that ivonescimab significantly reduced the risk of disease progression or death by 49% compared to Keytruda in first-line treatment of patients with PD-L1 positive advanced non-small cell lung cancer (NSCLC) in China. The trial showed a median progression-free survival (PFS) of 11.14 months for ivonescimab versus 5.82 months for Keytruda, with a hazard ratio of 0.51 and a p-value of less than 0.0001. This marks a historic first where a therapy has outperformed Keytruda in a late-stage lung cancer trial, potentially signaling a new standard of care. Akeso was involved in the trial.
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