Merck's Bintrafusp Alph Monotherapy In Biliary Cancer Misses Threshold For Regulatory Filing BERLIN (dpa-AFX) - 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.