Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Non-Epithelioid Malignant Pleural Mesothelioma (MPM)
Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of KEYTRUDA® (pembrolizumab) in combination with pemetrexed and platinum chemotherapy as a first-line treatment for adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM).
Dr. Gregory Lubiniecki, Vice President of Oncology Clinical Research at Merck Research Laboratories, emphasized that the positive opinion marks a significant milestone for patients with non-epithelioid mesothelioma, who face poorer survival outcomes compared to those with the epithelioid form. This recommendation brings Merck closer to providing a new first-line treatment option with demonstrated overall survival benefits for these patients in Europe.
The recommendation is based on data from the Phase 2/3 IND.227/KEYNOTE-483 trial, which showed KEYTRUDA plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone. The CHMP’s opinion will now be reviewed by the European Commission, with a decision expected in Q4 2024.
In the U.S., KEYTRUDA plus chemotherapy was approved in September 2024 for the first-line treatment of adult patients with unresectable advanced or metastatic MPM, based on the same trial. Results showed a 21% reduction in the risk of death (HR=0.79) and a significant improvement in progression-free survival (PFS) and overall response rate (ORR) for KEYTRUDA plus chemotherapy compared to chemotherapy alone. Adverse reactions were consistent with those observed in other KEYTRUDA treatment regimens.
About malignant mesothelioma
Malignant mesothelioma is a type of cancer that starts in the linings of certain parts of the body, including the chest, abdomen, heart and testicles. Worldwide, it was estimated there were more than 30,000 new cases of mesothelioma diagnosed and more than 25,000 deaths from the disease in 2022. In Europe, it was estimated there were approximately 14,700 new cases of mesothelioma diagnosed and more than 12,200 patient deaths from the disease in 2022. Pleural mesothelioma, which develops in the lining of the lungs, is the most common form of malignant mesothelioma, accounting for about 75% of all cases. Malignant pleural mesothelioma is categorized by histopathological subtypes: epithelioid, which accounts for 69% of cases, and non-epithelioid (sarcomatoid or biphasic), which accounts for 31% of cases.
