Merck Drops Late-Stage Cancer Drug Trial Due to Disappointing Efficacy

Merck announced that it is ending a phase 3 study evaluating its immunotherapy bintrafusp alfa in patients with stage IV non-small-cell lung cancer, following disappointing efficacy results.

The decision was made after the trial board’s independent data monitoring committee said the primary endpoint of progression-free survival was unlikely to be achieved.

Launched in 2018, the study was originally meant to include 584 patients randomized to receive either bintrafusp alfa or Merck’s Keytruda (pembrolizumab), but the company capped enrollment in October 2020 at 300 patients after an interim analysis.

Merck is jointly developing the immunotherapy with GlaxoSmithKline in a deal valued at up to $4.5 billion, including an upfront payment from GSK of $343 million and the balance in potential milestone payments.

Merck said it will continue to evaluate the drug in additional studies. Bintrafusp alfa is currently being investigated in ongoing trials for cervical, triple-negative breast and urothelial cancer, and the company expects result from a biliary tract cancer study early this year. ― Jason Scott