Yet another blow to Merck’s cancer hopeful

Merck KGaA announced it has decided to discontinue the Phase II INTR@PID BTC 055 study evaluating bintrafusp alfa with gemcitabine plus cisplatin in the first-line treatment of patients with locally advanced or metastatic biliary tract cancer. According to the Darmstadt-based company, the study is unlikely to achieve the primary objective of overall survival.

Bintrafusp alfa is the compound at the heart of a €3.7bn partnership with GlaxoSmithKline forged in early 2019. Back then, Merck received an upfront payment of €300m and was anticipating milestone payments exceeding €3bn. Now, however, the future of the bifunctional immunotherapy is doubtful.

In January, the company had already stopped the clinical trial INTR@PID Lung 037 investigating the drug in patients with stage IV non-small cell lung cancer. In March of this year, the company announced discouraging results from its Phase II study INTR@PID BTC 047 evaluating bintrafusp alfa as a monotherapy in patients with biliary tract cancer. Now, another trial has been halted. There are still a number of trials ongoing in lung cancer and cervical cancer – it remains to be seen if those are enough to keep the GSK-partnership going.