In the study of 159 patients, bintrafusp alfa demonstrated single-agent efficacy and durability with a manageable safety profile after more than nine months of follow-up
Merck announced topline data from the Phase II INTR@PID BTC 047 study evaluating bintrafusp alfa as a monotherapy in the second-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) who have failed or are intolerant of first-line platinum-based chemotherapy.
In the study of 159 patients, bintrafusp alfa demonstrated single-agent efficacy and durability with a manageable safety profile after more than nine months of follow-up, with an Independent Review Committee (IRC)-adjudicated objective response rate (ORR) of 10.1 per cent (95 per cent CI: 5.9 per cent to 15.8 per cent) per RECIST 1.1. Though single-agent activity was observed, the study did not meet the pre-defined threshold that would have enabled regulatory filing for BTC in the second-line setting. The results will be submitted for presentation at an upcoming medical meeting or publication.
“Given the high unmet treatment need in BTC, where single-agent immunotherapy in PD-L1 all comers has shown an ORR of 5.8 per cent , we are encouraged by the single-agent clinical activity of bintrafusp alfa in this study as a second-line treatment,” said Milind Javle, MD, professor of GI medical oncology, MD Anderson Cancer Center, and an investigator for the INTR@PID BTC 047 study. “The bintrafusp alfa 047 study is one of the most important clinical investigations conducted for chemo-refractory biliary cancers, and I would like to thank the patients, families, and study team for their valuable participation.”
“This study demonstrates single-agent activity with bintrafusp alfa in locally advanced or metastatic BTC, a disease that has been historically difficult to treat,” said Danny Bar-Zohar, Global Head of Development for the Healthcare business sector of Merck. “The data will contribute to our understanding of addressing both TGF-β and PD-L1 inhibition in the tumour microenvironment.”
A Phase II/III study of bintrafusp alfa in combination with chemotherapy as a first-line treatment for BTC (INTR@PID BTC 055), which is assessing a different hypothesis than the second-line monotherapy study, has completed enrollment in the Phase II portion and is currently ongoing.