Friday, May 3, 2013

DID YOU KNOW?

"FDA Grants Breakthrough Therapy Designation For PD-1 Targeted Antibody Lambrolizumab

Staff Writer
Published Online: Thursday, April 25, 2013
An investigational antibody designed to target the programmed death-1 (PD-1) pathway in patients with advanced melanoma received a Breakthrough Therapy designation from the FDA. Lambrolizumab demonstrated benefit from a small single-arm study.

Lambrolizumab, developed by Merck and formerly known as MK-3475, is a humanized monoclonal IgG4 antibody that acts against PD-1. In the results of a phase I trial that were presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2012, the antibody was studied in nine patients with a variety of tumor types, including two patients with melanoma. The drug was well-tolerated and generated antitumor activity in three different doses.

Interim results from a phase IB study reported in November revealed data from 85 of 132 patients enrolled in the single-arm study. Merck reported that 43 patients (51%) showed an objective anti-tumor response and 8 patients (9%) showed a complete response at or after an assessment performed at 12 weeks. Further, 11 of 27 patients (41%) who had been previously treated with ipilimumab monotherapy for late-stage melanoma showed an objective antitumor response.

In general, MK-3475 was well-tolerated, with the most common adverse events including fatigue, rash, diarrhea, nausea, cough, joint pain, fever, and itching. Seven grade 3/4 events were reported as potentially immune-related."

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