The comprehensive INTR@PID programme is designed to assess the impact of bintrafusp alfa across distinct cancers
Merck, Darmstadt, Germany, announced an update on the Phase III INTR@PID Lung 037 study and the extensive INTR@PID clinical trial programme 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 programme 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 tumour propagation and metastatic potential such as local immunosuppression, fibrosis, growth of tumour blood vessels and chemo- or radiotherapy resistance through several mechanisms. Trapping TGF-β in the tumour microenvironment on top of PD-L1 blockade is thought to be transformative in different clinical settings.
While reviewing the totality of data from the ongoing clinical trial INTR@PID Lung 037 in the first-line treatment of patients with stage IV non-small-cell lung cancer (NSCLC) that have high expression of PD-L1, the Independent Data Monitoring Committee recommended on January 19, 2021, to discontinue the clinical trial. Based on this recommendation, Merck KGaA, Darmstadt, Germany has decided to discontinue the clinical trial, as the study is unlikely to meet the co-primary endpoint, specifically progression-free survival. The recommendation by the Independent Data Monitoring Committee and the Company’s decision is related only to this clinical trial.
“We have pioneered the science behind bintrafusp alfa, and now through a strategic alliance, multiple non-correlated parallel hypotheses are being evaluated across numerous indications in our extensive INTR@PID clinical program,” said Danny Bar-Zohar, Global Head of Development for the Healthcare business of Merck, Darmstadt, Germany.
“We remain committed to further evaluation of bintrafusp alfa, and these data from INTR@PID Lung 037 will provide important insights that may be applied to future studies.”
