- Approval based on CheckMate -743 trial results showing that Opdivo plus Yervoy significantly increased overall survival vs. standard-of-care chemotherapy – the first positive Phase 3 trial of an immunotherapy in this patient population
- Opdivo plus Yervoy is the first new treatment option that has demonstrated improved survival to be authorized for patients with mesothelioma in more than 15 years
- Opdivo plus Yervoy-based combinations now indicated in the European Union for four different advanced cancer types: mesothelioma, non-small cell lung cancer, melanoma and renal cell carcinoma
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM). The EC’s decision is based on results from the CheckMate -743 trial, the first and only positive Phase 3 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 MPMwas 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.”
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 (EU), 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.
“Mesothelioma can be a devastating diagnosis for patients and their families, and the disease has a significant impact throughout Europe, which has the highest incidence rate of mesothelioma globally,” said Stefania Vallone, board member, Women Against Lung Cancer in Europe. “Mesothelioma is often detected decades after exposure to asbestos, and for years these patients have faced this aggressive cancer with few treatment options. We are pleased to see a new therapy approved that may offer patients and their families hope for a longer life. Our wish is that it will soon be available in all European countries.”
“The European Commission’s approval of Opdivo plus Yervoy is a crucial step in addressing the unmet needs of patients with malignant pleural mesothelioma. In the CheckMate -743 trial, this dual immunotherapy combination demonstrated a clinically meaningful improvement in survival over the standard of care, with 41% of patients who received Opdivo plus Yervoy still alive at two years, compared to only 27% with chemotherapy,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “We thank the patients and investigators involved in the CheckMate -743 trial, whose contributions were essential to bringing the first immunotherapy option to mesothelioma patients throughout the EU.”
