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Merck's Bintrafusp Alph Monotherapy In Biliary Cancer Misses Threshold For Regulatory Filing

Merck KGaA (MKGAY.PK) Tuesday announced a single agent efficacy second-line treatment using bintrafusp alpha monotherapy in locally advanced or metastatic biliary tract cancer or BTC patients. However, the study missed the pre-defined threshold that would have enabled regulatory filing for BTC in the second-line setting.

The study enrolled 159 patients, who have failed or are intolerant of first-line platinum-based chemotherapy.

The results demonstrated single-agent efficacy and durability with a manageable safety profile after more than nine months of follow-up.

The company said the Phase II/III study of bintrafusp alfa in combination with chemotherapy is the first-line treatment for BTC.

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