Merck KGaA has breathed some life back into its lung cancer vaccine, which many wrote off after it tanked in a Phase III trial in late 2012. After vowing to make a renewed effort to find some value in the jab last September, this week the company announced the start of a new Phase III study.
In the START2 trial, Merck will test the immunotherapy--which goes by the name of tecemotide, formerly Stimuvax--in patients with Stage 3 non-small cell lung cancer whose disease has remained unchanged or whose tumors have shrunk after receiving chemo and radiation. The company has already dosed the first patient in the study, which is recruiting in more than 20 countries, with a primary endpoint of overall survival.
It's a new lease on life for the shot, whose 2012 failure dragged shares of Merck's partner, Oncothyreon ($ONTY), down by 50% in one day. But as the company insists, the vaccine was never dead. Even after the Phase III flunk, the company pushed forth on an Asian study, with investigators homing in on positive results in patient subgroups. And last summer, Merck reorganized to put tecemotide in a new immunotherapy unit along with a handful of other candidates in their early stages.
Guiding immunotherapies through the clinic has so far proved a dicey business, with companies like GlaxoSmithKline ($GSK) and Amgen ($AMGN) both hitting snags as of late. Even Dendreon ($DNDN), which grabbed FDA approval for cancer jab Provenge in 2010, struggled with investors after bringing the product to market.
But Dr. John Orloff, Merck Serono's global head of clinical development, says the company is unfazed. "We are pleased that START2 is now underway, and feel confident that this study will address the appropriate gaps in understanding the potential role that tecemotide could play in the management of patients living with unresectable Stage 3 NSCLC," he said in a statement.
- read the release