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FDA Approves Merck's KEYTRUDA® (Pembrolizumab) in Combination with Pemetrexed and Platinum Chemotherapy as a First-Line Treatment for Adults with Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma (MPM)

NextEdge Admin

19 Sep 2024

2 min 28 sec

Merck , known as MSD outside the U.S. and Canada, has announced that the U.S. Food and Drug Administration (FDA) approved KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). This approval follows positive data from the Phase 2/3 IND.227/KEYNOTE-483 trial.

The trial showed that the combination therapy significantly improved overall survival (OS), reducing the risk of death by 21% compared to chemotherapy alone (HR=0.79; p=0.0162). Median OS was 17.3 months for patients receiving KEYTRUDA plus chemotherapy versus 16.1 months for chemotherapy alone. Progression-free survival (PFS) also improved (HR=0.80; p=0.0194), with a median PFS of 7.1 months in both treatment groups. The overall response rate (ORR) was notably higher at 52% for the combination therapy compared to 29% for chemotherapy alone.

The study enrolled 440 patients with advanced or metastatic MPM, regardless of PD-L1 expression, and included patients without prior systemic therapy. Adverse reactions were generally consistent with those previously observed for KEYTRUDA in combination with chemotherapy, including immune-mediated adverse effects. Early identification and management of these reactions are critical for safe treatment.

Dr. Gregory Lubiniecki, vice president of oncology clinical research at Merck, emphasized the significance of this approval for MPM patients, a population with historically poor prognoses. This milestone highlights Merck’s dedication to advancing treatments for challenging cancers.

The trial was conducted in collaboration with international research groups, and Merck provided KEYTRUDA and support for the study.