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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Pemetrexed and Platinum Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma (MPM)

Published: 2024-09-18 10:45:00 ET

Approval based on results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival versus chemotherapy alone

Approval marks the first indication for KEYTRUDA in MPM in the U.S.

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

The approval is based on data from the pivotal Phase 2/3 IND.227/KEYNOTE-483 trial. In IND.227/KEYNOTE-483, KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 21% (HR=0.79 [95% CI, 0.64-0.98]; p=0.0162) compared to chemotherapy alone at the trial’s pre-specified final analysis. Median OS was 17.3 months (95% CI, 14.4-21.3) for KEYTRUDA plus chemotherapy versus 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. KEYTRUDA plus chemotherapy also significantly improved progression-free survival (PFS) versus chemotherapy alone (HR=0.80 [95% CI, 0.65-0.99], p=0.0194; median PFS 7.1 months [95% CI, 6.9-8.1] versus 7.1 months [95% CI, 6.8-7.7], respectively). Overall response rate (ORR) was significantly higher for KEYTRUDA plus chemotherapy versus chemotherapy alone (52% [95% CI, 45.5-59.0] versus 29% [95% CI, 23.0-35.4], respectively; p

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