Merck’s KEYTRUDA receives FDA approval for treatment of MPM

Merck announced the 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, or 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, or OS, reducing the risk of death by 21% compared to chemotherapy alone at the trial’s pre-specified final analysis. Median OS was 17.3 months for KEYTRUDA plus chemotherapy versus 16.1 months for chemotherapy alone. KEYTRUDA plus chemotherapy also significantly improved progression-free survival, or PFS, versus chemotherapy alone. Overall response rate, or ORR, was significantly higher for KEYTRUDA plus chemotherapy versus chemotherapy alone versus 29%. Adverse reactions occurring in patients with MPM were generally similar to those in other patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy.