When Merck KGaA's lung cancer vaccine flunked Phase III in December, many considered the program dead. While the press release highlighted efficacy in certain subpopulations, investors and analysts were skeptical. Shares in Merck's partner Oncothyreon ($ONTY) fell 50% in a day.
Merck KGaA is still talking about the vaccine, though. In the wake of the clinical failure, the company decided to push on with another ongoing late-phase trial in Asia and is now weighing the options of starting a further study. A decision, which will be partly dependent on the outcome of talks with regulators, is expected later this year. If Merck KGaA can define a clear pathway to approval, the vaccine formerly known as Stimuvax could once again enter late-phase trials.
"The message really is, the program isn't dead," head of pharmaceuticals Stefan Oschmann told Bloomberg. Merck still lists the vaccine--now referred to by its nonproprietary name, tecemotide--on its recently revamped pipeline slide. The vaccine is now part of the new immuno-oncology unit. Merck created the unit last week to bring together its assets in the hotly tipped cancer immunotherapy sector.
Tecemotide is the most advanced product in the group. Merck has three other immunotherapies in Phase I--including one targeting the PD-L1 protein that was hyped at ASCO--and others still in preclinical. Merck faces stiff competition though. Bristol-Myers Squibb ($BMS), Merck ($MRK) and Roche ($RHHBY) subsidiary Genentech are all separately going after PD-1 and PD-L1 too.
Perhaps tellingly, the press release to discuss the formation of the unit lists the three Phase I therapies as the "leading therapeutic concepts" in the clinic. Tecemotide is never referred to by name in the release. Therapeutic cancer vaccines are listed as one of three fields targeted by the new unit.
- here's the Bloomberg article
- check out the Merck release
- view the new pipeline slide