The trial did not meets its first or second co-primary outcomes, extending disease-free survival compared to patients receiving a placebo or patients who did not receive chemotherapy.
However, researchers decided to continue with the trial to see if disease-free survival was possible in a MAGE-A3 (a tumor-specific antigen expressed in certain cancers but not in normal cells) positive sub-population of patients. A third-party analysis shows such assessment is not feasible due to insufficient treatment effect.
“While we are extremely disappointed to learn that this trial did not have a positive outcome for the patients who participated in this trial, we are very grateful to its participants. We hope that the data generated in this trial will advance our understanding of the science of immunotherapeutics, and ultimately towards development of new therapies,” said Vincent Brichard, senior vice president and head of immunotherapeutics of GSK Vaccines, in a news release.
Researchers have continued to evaluate another phase III clinical trial to see if a gene signature can identify a subpopulation of melanoma patients who may benefit from the same immunotherapeutic.
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