FDA approves Keytruda(pembrolizumab) plus pemetrexed and platinum chemotherapy as first-line treatment for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma
Merck Inc., (known as MSD outside of the United States and Canada), 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 (MPM)
The approval is based on data from the pivotal Phase II/III 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<0.00001). Adverse reactions occurring in patients with MPM were generally similar to those in other patients receiving Keytruda in combination with pem.etrexed and platinum chemotherapy.
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