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BMS receives European Commission approval for Opdivo + Yervoy as first-line treatment for unresectable malignant pleural mesothelioma.

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Published:3rd Jun 2021
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 III 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 MPM was 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 (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. Results from the CheckMate -743 trial include : i. 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. ii. 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. iii. 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). iv. Progression-free survival (PFS): The median time that patients lived without disease progression or death was 6.8 months with Opdivo plus 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 Opdivo plus Yervoy, were fatigue (43%), diarrhea (31%), rash (30%), musculoskeletal pain (27%), nausea (24%), decreased appetite (24%), pruritus (21%), constipation (19%) and hypothyroidism (13%). “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.”

Condition: Malignant Mesothelioma
Type: drug

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