Merck KGaA Phase III bintrafusp alfa trial flop in lung cancer

German pharma and life sciences major Merck KGaA (MRK: DE) saw its shares close down 3.7% at 143.40 euros yesterday, after it announced a disappointing update on the Phase III INTR@PID Lung 037 study and the extensive INTR@PID clinical trial program for the potential first-in-class investigational bifunctional immunotherapy bintrafusp alfa, in difficult-to-treat cancers, including biliary tract cancer (BTC) and cervical cancer.

The comprehensive INTR@PID program is designed to assess the impact of bintrafusp alfa across distinct cancers and settings where TGF-β is thought to play a driving role. TGF-β is a cytokine that is known to be associated with tumor propagation and metastatic potential such as local immunosuppression, fibrosis, growth of tumor blood vessels and chemo- or radiotherapy resistance through several mechanisms. Trapping TGF-β in the tumor microenvironment on top of PD-L1 blockade is thought to be transformative in different clinical settings.

Study discontinued as unlikely to meet the co-primary endpoint