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GSK: Immunotherapeutic did not meet co-primary endpoint in melanoma study
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GlaxoSmithKline reported today that a phase 3 trial of its cancer immunotherapeutic did not meet its first co-primary endpoint of significantly extending disease-free survival in patients with melanoma when compared with placebo.
The efficacy and safety of the protein melanoma-associated antigen-A3 (MAGE-A3) immunotherapeutic in stage III B/C melanoma patients with macroscopic nodal disease, whose tumors expressed the MAGE-A3 gene and had the tumors surgically removed, was evaluated in the DERMA study, according to a press release. MAGE-A3, expressed in 65% of stage III melanomas, is a tumor-specific antigen with no presentation in normal cells.
The randomized, blinded trial will continue until the second co-primary endpoint — disease-free survival in the gene signature positive sub-population — is assessed, GlaxoSmithKline (GSK) reported. Analysis results are expected in 2015. The Independent Data Monitoring Committee raised no safety concern for trial continuation during an informational review of the study, GSK said.
“We remain committed to identifying a patient sub-population who may benefit from this investigational treatment,” Vincent Brichard, MD, PhD, senior vice president and head of immunotherapeutics, GSK Vaccines, said in the release.
The MAGE-A3 cancer immunotherapeutic also is being investigated in a phase 3 study in nonsmall cell lung cancer following surgical removal of the primary tumor, GSK reported. Study results are expected in the first half of 2014.