Home Merck's Keytruda-Based Perioperative Regimen Meets Phase 3 Primary Endpoint, Reducing Risk of Recurrence, Progression, or Death by 42% in Resectable NSCLC

Merck's Keytruda-Based Perioperative Regimen Meets Phase 3 Primary Endpoint, Reducing Risk of Recurrence, Progression, or Death by 42% in Resectable NSCLC

Jun 04, 2023 08:03 CST Updated 08:03
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SmartCom Finance APP learned that Merck & Co., Inc. (MRK.US) announced positive results from the pivotal Phase 3 clinical trial KEYNOTE-671 today. This trial evaluated the重磅 anti-PD-1 therapy Keytruda, as a pre-surgery (neoadjuvant) and post-surgery (adjuvant) treatment for patients with resectable Stage II, Stage IIIA, or Stage IIIB non-small cell lung cancer (NSCLC).

The trial results showed that, at a median follow-up of 25.2 months, neoadjuvant Keytruda plus chemotherapy as neoadjuvant therapy, followed by Keytruda monotherapy as adjuvant therapy after surgery, significantly improved event-free survival (EFS) compared to placebo plus chemotherapy as neoadjuvant therapy followed by placebo as adjuvant therapy, reducing the risk of disease recurrence, progression, or death by 42% (HR=0.58, [95% CI, 0.46-0.72], p<0.00001). The median EFS for patients receiving the Keytruda-based regimen was not reached (95% CI, 34.1-NR), while the EFS for patients receiving chemotherapy alone was 17 months (95% CI, 14.3-22).