After a failed attempt to revive its late-stage program for Stimuvax, Merck KGaA is once again throwing in the towel on the cancer vaccine. The German company's biopharma division will cut its two monotherapy studies in the wake of another recent trial failure in Japan, it said late last week.
The move comes about a year after the Darmstadt-based drugmaker renamed the candidate tecemotide and gave it a new lease on life, chasing after some promise it ID'd in a subpopulation of non-small cell lung cancer patients after flunking a Phase III trial.
But late last month, partner Oncothyreon ($ONTY) reported that that quest wasn't going so well: Tecemotide missed its main goal of improving overall survival in a randomized Phase I/II study of Japanese patients with stage III non-small cell lung cancer, it said in an SEC filing. And to make matters worse, the vaccine showed no treatment effect in any of the trial's secondary endpoints in progression-free survival, time to progression and time to failure.
The discontinuation of the tecemotide program will come as no surprise to the doubters who scrutinized Merck's decision to pick the program back up in the first place. After all, tecemotide is not the first to flop in the troubled cancer vaccine field; just ask GlaxoSmithKline ($GSK), whose MAGE-A3 failed to outperform a placebo in a Phase III trial of 1,345 melanoma patients last September. But Merck maintains the revisit was justified.
"While the data from the exploratory subgroup analysis in the START trial generated a reasonable hypothesis to warrant additional study, the results of the recent trial in Japanese patients decreased the probability of current studies to reach their goals," R&D chief Luciano Rossetti said in a statement.
- read Merck's release