KEYTRUDA Shows Significant Survival Benefit In Treatment Of MPM And Earns EU Recommendation

Merck, 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 EU approval of KEYTRUDA® (pembrolizumab). The anti-PD-1 therapy, in combination with pemetrexed and platinum-based chemotherapy, is proposed for first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM).  

Dr. Gregory Lubiniecki, vice president of oncology clinical research at Merck Research Laboratories, said in a statement, “The CHMP’s positive opinion marks an important milestone for patients in Europe with non-epithelioid mesothelioma, who experience worse survival outcomes than patients with epithelioid mesothelioma. The positive CHMP opinion moves us closer to offering a new first-line treatment option with a proven overall survival benefit for certain patients in the European Union with this difficult-to-treat cancer.”

The recommendation is based on findings from the pivotal Phase 2/3 IND.227/KEYNOTE-483 trial, which demonstrated that KEYTRUDA plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone. The European Commission will now review the CHMP's recommendation, with a final decision on marketing authorization in the European Union expected in the fourth quarter of 2024.

In September 2024, the U.S. FDA approved KEYTRUDA in combination with pemetrexed and platinum chemotherapy for first-line treatment of unresectable advanced or metastatic MPM based on KEYNOTE-483 results. The trial showed a 21% reduction in the risk of death, with a median OS of 17.3 months for the KEYTRUDA combination versus 16.1 months for chemotherapy alone. Progression-free survival (PFS) was also significantly improved, as was the overall response rate (ORR), which was 52% with KEYTRUDA plus chemotherapy compared to 29% with chemotherapy alone (p<0.00001). The safety profile of KEYTRUDA in this setting was consistent with previous findings for the drug in combination therapy.