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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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R&D In Brief

Motavizumab reduced hospitalization in Phase III trial: MedImmune's motavizumab reduced hospitalizations due to respiratory syncytial virus by 83 percent compared to placebo in a Phase III trial, the firm says May 4. The monoclonal antibody is being evaluated for its potential to prevent serious disease caused by RSV in high-risk pediatric patients. The trial showed a 71 percent reduction in the incidence of RSV-specific lower respiratory infections requiring outpatient management, which was the study's secondary endpoint. The randomized, double-blind study involved 1,410 full-term healthy infants less than six months old in certain Southwest Native American populations and was designed to compare monthly intramuscular injections of motavizumab against placebo. The study confirmed what previous epidemiological studies have shown: that these populations have high rates of hospitalization due to RSV. Motavizumab would be a follow-on to AstraZeneca's Synagis (palivizumab)

Ipilimumab Filing For Metastatic Melanoma Planned Despite Phase III Failure

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


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