Weak Results Stop Pfizer's Tremelimumab Phase III Trial; Bristol Keeps Going
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pfizer discontinues single-agent trial of the CTLA-4 inhibitor in advanced melanoma, but Bristol-Myers Squibb announced it is still moving forward with its CTLA-4 inhibitor ipilimumab, which also failed a monotherapy melanoma trial
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Despite failing to meet the primary endpoint of a key study, Medarex/Bristol-Myers Squibb's investigational CTLA-4 inhibitor ipilimumab should be approved by regulators based on the totality of the data from the registration program and the limited treatment options for metastatic melanoma patients, the companies maintained