The European Commission has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma.
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 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 MPMwas manageable using established adverse event management protocols and consistent with previous studies of the combination in other tumor types.
The EC decision allows for the use of Opdivo plus Yervoy in first-line unresectable MPM in the 27 member states of the European Union, as well as Iceland, Liechtenstein and Norway. In addition to the EU, the combination has been approved in six countries, including the United States, and additional regulatory applications are under review by global health authorities.
