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Bintrafusp alfa monotherapy effective, durable in biliary tract cancer

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Bintrafusp alfa monotherapy (Merck) demonstrated single-agent efficacy and durability 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, according to a press release.

Bintrafusp alfa was evaluated in 159 patients in the Phase 2 [email protected] BTC 047 study. At >9 months follow up, there was an Independent Review Committee-adjudicated objective response rate of 10.1% (95% CI: 5.9% to 15.8%) per RECIST 1.1.

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%, 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 [email protected] BTC 047 study in a press release. “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.”

Read the full press release here.

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