Merck KGaA, GSK's bintrafusp alfa chalks up another loss in biliary tract cancer

Merck KGaA said Monday it has decided to pull the plug on a Phase II study evaluating bintrafusp alfa as a potential treatment for patients with locally advanced or metastatic biliary tract cancer (BTC). Merck said the decision to terminate INTR@PID BTC 055, which was testing the GlaxoSmithKline-partnered drug with gemcitabine plus cisplatin for first-line patients with the disease, follows a review by an independent data monitoring committee (IDMC) indicating the study was unlikely to achieve its primary objective of overall survival.

No new safety signals were identified, and Merck said it would share data and analyses from the study with the scientific community in the future.

Third key study failure this year

In March, Merck reported that bintrafusp alfa, which is designed to block both TGF-β and PD-L1, had also failed the Phase II INTR@PID BTC 047 trial testing the experimental treatment for second-line locally advanced or metastatic BTC. At the time, the company noted that while single-agent activity was observed for the bifunctional immunotherapy, the trial did not meet the pre-defined threshold that would have enabled regulatory filings in this indication.

A few months prior to that, Merck discontinued the Phase III INTR@PID Lung 037 study testing bintrafusp alfa as a first-line treatment for stage IV non-small-cell lung cancer in patients with high PD-L1 expression, saying the trial's IDMC had determined that the co-primary endpoint of progression-free survival would probably not be met.

The therapy, also known as M7824, is being co-developed with GlaxoSmithKline under a 2019 alliance potentially worth up to €3.7 billion ($4.3 billion), including an upfront payment of €300 million ($352 million) to Merck.

August 23rd, 2021

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