Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab). The approval allows for the use of Keytruda in combination with pemetrexed and platinum chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). This decision is supported by robust data from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated a significant improvement in overall survival (OS) with the combination therapy, reducing the risk of death by 21% compared to chemotherapy alone.
In the trial, the median OS was 17.3 months for patients treated with Keytruda plus chemotherapy, compared to 16.1 months for those on chemotherapy alone. The overall response rate (ORR) was also notably higher at 52% for the Keytruda combination group versus 29% for the chemotherapy-only group. This approval marks a significant advancement in the treatment landscape for MPM, a rare and aggressive form of cancer with limited therapeutic options.
Malignant mesothelioma, which originates from the endothelial linings of various body cavities, including the chest, abdomen, heart, and testicles, is a rare cancer with over 30,000 new cases diagnosed globally and 25,000 deaths reported in 2022. Pleural mesothelioma, the most prevalent form, accounts for approximately 75% of all malignant mesothelioma cases and is known for its rapid progression and poor prognosis, with five-year survival rates in the US standing at a mere 12.8%. – Flcube.com
