Health Canada Approves Bristol Myers’ Opdivo Plus Yervoy To Treat Mesothelioma – Quick Facts
Bristol Myers Squibb Canada Co., an indirect wholly-owned subsidiary of Bristol Myers Squibb Co. (BMY) announced Wednesday Health Canada’s approval of OPDIVO (nivolumab) 360 mg every three weeks or 3mg/kg every two weeks plus YERVOY (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.
This is the first and only dual immunotherapy treatment for the condition. Unlike traditional cancer therapies that target the tumour directly, immuno-oncology activates the body’s own immune system to help recognize and attack cancer cells.
Mesothelioma is a rare and aggressive form of cancer that is mainly caused by asbestos exposure and most often affects the pleural lining (the lining surrounding the lungs).
The Health Canada approval was based on a pre-specified interim analysis from the Phase 3 CheckMate-743 trial in which OPDIVO plus YERVOY demonstrated superior overall survival (OS) versus the platinum-based standard of care chemotherapy.
The primary endpoint of the trial was OS in all randomized patients. Additional efficacy outcome measures included progression-free survival (PFS), and objective response rate (ORR).
CheckMate-743 (NCT02899299) is an open-label, multi-center, randomized Phase 3 trial evaluating OPDIVO plus YERVOY compared to chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with histologically confirmed unresectable malignant pleural mesothelioma and no prior systemic therapy or palliative radiotherapy within 14 days of initiation of therapy.
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