- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Cancer Vaccine Disappoints in Melanoma Trial
Immunotherapeutic agent fails to extend disease-free survival (September 5)
An independent analysis of the DERMA trial — a phase III randomized, blinded, placebo-controlled study of the MAGE-A3 cancer immunotherapeutic — has shown that the study did not meet its first co-primary endpoint as it did not significantly extend disease-free survival (DFS) when compared with placebo in the MAGE-A3–positive population.
The study evaluated the efficacy and safety of the MAGE-A3 cancer immunotherapeutic in stage IIIB/C melanoma patients with macroscopic nodal disease whose tumors expressed the MAGE-A3 gene and who had their tumors removed surgically. MAGE-A3 is a tumor-specific antigen that is expressed in a variety of cancers, including melanoma, with no presentation in normal cells. MAGE-A3 is expressed in about 65% of stage III melanomas.
The drug’s developer (GlaxoSmithKline) will continue the DERMA trial until the second co-primary endpoint is assessed. This endpoint — DFS in the gene signature-positive subpopulation — is designed to identify a subset of MAGE-A3–positive patients that may benefit from the treatment. Results from this analysis are expected in 2015.
The same investigational MAGE-A3 cancer immunotherapeutic is being investigated in another phase III study (MAGRIT) in non–small-cell lung cancer (NSCLC) following surgical removal of the primary tumor, with first data anticipated in the first half of 2014.
Source: GSK; September 5, 2013.