Can Patients With Melanoma Benefit From Antigen-Specific Immunotherapeutic?
Posted: Thursday, September 6, 2018
In patients with resected MAGE-A3-positive stage 3 melanoma, the adjuvant MAGE-A3 immunotherapeutic was found to be clinically ineffective. Brigitte Dreno, MD, of the Hotel Dieu Nantes University Hospital, and colleagues, published the findings of DERMA, a phase III, double-blinded, randomized, placebo-controlled trial, in The Lancet Oncology. The MAGE-A3 immunotherapeutic consists of a combination of the recombinant MAGE-A3 protein and the immunostimulant AS15.
“Treatment with the MAGE-A3 immunotherapeutic did not improve disease-free survival, overall survival, or any other clinical outcome in the overall population of patients with advanced melanoma, nor in subgroups according to tumor characteristics or treatment procedures,” concluded the authors. “Based on these findings, development of the MAGE-A3 immunotherapeutic for use in melanoma has been stopped.”
In reportedly the largest trial of its kind conducted in this patient population, 1,345 patients with completely resected, stage IIIB or IIIC, MAGE-A3-positive cutaneous melanoma with macroscopic lymph node involvement and an Eastern Cooperative Oncology Group performance score of 0 or 1 were randomized to receive the MAGE-A3 immunotherapeutic (n = 895) or placebo (n = 450). Dr. Dreno and colleagues noted that although the MAGE-A3 immunotherapeutic was generally safe and produced immune responses, clinical significance was not established. The median disease-free survival was essentially the same with the novel treatment and the placebo (11 months vs. 11.2 months).