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Bristol Myer: Phase 3 Trial On Head & Neck Cancer Fails To Meet Primary Endpoints
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Bristol Myers Squibb Provides Update on CheckMate -651 Trial Evaluating Opdivo Plus Yervoy Versus EXTREME Regimen as First-Line Treatment for Squamous Cell Carcinoma of the Head and Neck
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Opdivo, Yervoy combination approved to treat malignant pleural mesothelioma
3rd June 2021
Bristol Myers Squibb’s Opdivo plus Yervoy combination treatment has been approved in the EU for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM).
The European Commission’s (EC) approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) in this patient population is based on data from the CheckMate-743 trial.
This trial met its primary endpoint, with Opdivo plus Yervoy reducing the risk of death by 26% and demonstrating a median overall survival (OS) of 18.1 months versus 14.1 months for platinum-based standard-of-care chemotherapy.
The overall response rate (ORR) was similar across the Opdivo plus Yervoy and chemotherapy arms at 40% and 43% respectively, while duration or response (DoR) was improved with the immunotherapy combination compared to chemotherapy – 11.0 months versus 6.7 months.
Patients treated with Opdivo plus Yervoy with two cycles of chemotherapy showed sustained improvements in overall survival and progression-free survival and increased duration of response vs. chemotherapy at two years Dual immunotherapy-based combination demonstrated clinical benefit across key subgroups of patients, regardless of PD-L1 expression level or histology Data to be featured in an oral presentation during … Patients treated with Opdivo plus Yervoy with two cycles of chemotherapy showed sustained improvements in overall survival and progression-free survival and increased duration of response vs. chemotherapy at two years Dual immunotherapy-based combination demonstrated clinical benefit across key subgroups of patients, regardless of PD-L1 expression level or histology
Recommendation based on positive results from the Phase 3 CheckMate -743 trial, in which Opdivo plus Yervoy demonstrated significantly superior overall survival vs. standard-of-care chemotherapy CheckMate -743 represents the first Phase 3 trial to show benefit with immunotherapy in previously untreated malignant pleural mesothelioma If approved, Opdivo plus Yervoy will be the first new treatment option authorized … Recommendation based on positive results from the Phase 3 CheckMate -743 trial, in which Opdivo plus Yervoy demonstrated significantly superior overall survival vs. standard-of-care chemotherapy CheckMate -743 represents the first Phase 3 trial to show benefit with immunotherapy in previously untreated malignant pleural mesothelioma If approved, Opdivo
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