Merck announced positive results in two studies evaluating Keytruda®, its anti-PD-1 therapy.
Merck reported that its Phase 3 KEYNOTE-671 trial evaluating Keytruda® plus chemotherapy before surgery and continued as a single agent after surgery showed reduced risk of disease recurrence, progression or death by 42% versus pre-operative chemotherapy in resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). Merck previously announced that, based on these results, the U.S. Food and Drug Administration (FDA) accepted a new supplemental Biologics License Application (sBLA) for Keytruda® for the treatment of these patients in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment, with a target action date of October 16, 2023.
Merck also reported that its Phase 3 KEYNOTE-483 trial evaluating Keytruda® plus chemotherapy as first-line treatment for patients with unresectable advanced pleural mesothelioma showed significantly improved overall survival chemotherapy alone.
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