European Commission approves Opdivo + Yervoy as first-line treatment for unresectable malignant pleural mesothelioma.- BMS
The EC’s decision is based on results from the CheckMate -743 trial, the first and only positive Phase III study of an immunotherapy in first-line MPM. The trial met its primary endpoint, showing superior overall survival (OS) with Opdivo plus Yervoy versus chemotherapy (pemetrexed and cisplatin or carboplatin) in all randomized patients. The safety profile for Opdivo plus Yervoy in first-line MPM was manageable using established adverse event management protocols and consistent with previous studies of the combination in other tumor types. “After many years of limited progress in the treatment of malignant mesothelioma, we saw an important clinical benefit for patients with nivolumab plus ipilimumab in the CheckMate -743 trial,” said Paul Baas, M.D., Ph.D., Department of Thoracic Oncology, Netherlands Cancer Institute and the University of Leiden. “With the European Commission approval of this dual immunotherapy combination, patients and doctors will now have a new treatment option that has shown significant improvements in survival to manage this resistant disease.