Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma
PRINCETON, N.J.--(BUSINESS WIRE)--?Bristol Myers Squibb?(NYSE: BMY) today 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.?
CheckMate -743 Efficacy and Safety Results
Results from the CheckMate -743 trial include:
- OS?(primary endpoint):?Treatment with?Opdivo?plus?Yervoy?reduced the risk of death by 26% (Hazard Ratio [HR] 0.74, 96.6% Confidence Interval [CI]: 0.60 to 0.91; p=0.002), demonstrating a median OS of 18.1 months vs. 14.1 months for platinum-based standard-of-care chemotherapy.
- Overall response rate (ORR): ORR was similar across the?Opdivo?plus?Yervoy?and chemotherapy arms at 40% (95% CI: 34.1 to 45.4) and 43% (95% CI: 37.1 to 48.5), respectively.
- Duration of response (DoR):?DoR was improved with the dual immunotherapy combination (11.0 months; 95% CI: 8.1 to 16.5) compared to chemotherapy alone (6.7 months; 95% CI: 5.3 to 7.1). Of the patients who responded to?Opdivo?plus?Yervoy, 32% had ongoing responses at two years (vs. 8% of chemotherapy responders).
- Progression-free survival (PFS):?The median time that patients lived without disease progression or death was 6.8 months with?Opdivoplus?Yervoy?and 7.2 months with chemotherapy (HR: 1.00, 95% CI: 0.82 to 1.21).
- Safety:?The most frequent adverse reactions, occurring in 10% or more of patients treated with?Opdivoplus?Yervoy, were fatigue (43%), diarrhea (31%), rash (30%), musculoskeletal pain (27%), nausea (24%), decreased appetite (24%), pruritus (21%), constipation (19%) and hypothyroidism (13%).