CHMP recommends approval of Opdivo + Yervoy in malignant pleural mesothelioma.- Bristol Myers Squibb

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM). The positive CHMP opinion is based on results from CheckMate -743, the first and only positive Phase III immunotherapy trial in first-line MPM. The trial met the primary endpoint of 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 and consistent with previous studies of the combination in other tumor types. Results from CheckMate -743 were presented at the 2020 World Conference on Lung Cancer Virtual Presidential Symposium, hosted by the International Association for the Study of Lung Cancer, in August 2020 and published in The Lancet in January 2021.