EU submission complete for Opdivo + Yervoy application to treat untreated, unresectable malignant pleural mesothelioma. - BMS

Bristol Myers Squibb announced that the European Medicines Agency (EMA) validated a type II variation application for Opdivo(nivolumab) plus Yervoy(ipilimumab) for the treatment of patients with previously untreated, unresectable malignant pleural mesothelioma (MPM). Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. “Not only is malignant pleural mesothelioma a particularly aggressive cancer, it has also proven difficult to treat, with no new options approved in years that can meaningfully extend survival,” said Sabine Maier, M.D., vice president, Oncology Clinical Development, Bristol Myers Squibb. “The CheckMate -743 trial has shown the potential for Opdivo plus Yervoy to help address this significant unmet need. We look forward to working with urgency alongside the EMA towards the goal of bringing this dual immunotherapy combination to patients in Europe, which faces one of the highest incidences of mesothelioma in the world.” The type II variation application is supported by data from the pivotal Phase III CheckMate -743 trial, which 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 was consistent with previous studies of Opdivo plus Yervoy. 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 on August 8, 2020.