Merck KGaA’s Phase 3 trials of xevinapant, the cancer drug it licensed from Debiopharm in 2021, are winding down after the drug showed that it wouldn’t hit the primary endpoint in one of the trials.
Xevinapant was being tested in unresected locally advanced squamous cell carcinoma of the head and neck as well as in another trial of resected disease combined with radiotherapy. But the German pharma said Monday that the drug was “unlikely to meet its primary objective of prolonging event-free survival” in the first trial, and that the failure was enough to make the call to also wind down the second.
Merck KGaA brought in the drug through a licensing deal with Debiopharm that included a €188 million ($202 million) upfront, and milestones worth as much as €710 million ($762 million). The deal followed a mid-stage trial success for xevinapant, which showed that it reduced the risk of death by about half when used with chemotherapy, compared with placebo plus chemo.
It’s a blow for Merck KGaA, which has repeatedly touted its hopes for the drug based in part on those prior results. Earlier this year, it went so far as to call the study ending in futility as “unlikely” and discussed its hopes for a filing with the FDA.
The drug is an oral antagonist of inhibitor of apoptosis proteins, and was meant to take away a defense of tumors that blocks planned cell death. Merck KGaA has no other trials of the drug listed on its website beyond the two Phase 3 studies.