Merck Serono has announced that it will push on with development of its lung cancer jab tecemotide (L-BLP25) despite it failing to hit targets in a Phase III trial back in 2012.
The drugmaker has found a way forward for development of the drug, in a subset of non-small cell lung cancer (NSCLC) patients who seemed to benefit from treatment with its cancer immunotherapy in the START trial.
Building on data from this study, which failed to meet its primary endpoint of improving overall survival in the overall patient population, the new START II trial will assess tecemotide in patients with unresectable, locally advanced, stage III NSCLC who have shown stable disease or objective response after concurrent chemoradiotherapy (CRT).
This is because an exploratory analysis of patients in the START trial who received tecemotide after concurrent CRT showed that they achieved a median overall survival of 30.8 months versus 20.6 months for those given a placebo.
According to Charles Butts, clinical investigator of the START trial and member of the corresponding steering committee, findings from the 'failed' START trial "raised a lot of interest in the scientific community", because this type of clinically meaningful survival benefit hasn't been seen with any other investigational therapies in unresectable Stage III NSCLC.
"Further investigation might help to better understand the potential role that tecemotide could play in successfully treating these patients" he said.
The new international Phase III trial will be conducted under a Special Protocol Assessment with the US Food and Drug Administration, and Merck said is has also received advice from European regulators on the programme.