Merck's sBLA for Keytruda Plus Chemotherapy as First-Line Treatment for Biliary Tract Cancer Accepted by FDA

On June 8, MSD announced that the FDA has accepted the new indication application for Keytruda (K药) in combination with chemotherapy (gemcitabine and cisplatin) as a first-line treatment for advanced or unresectable biliary tract cancer (BTC). The PDUFA date is set for February 7, 2024.

This application is primarily based on the Phase III randomized, double-blind, placebo-controlled KEYNOTE-966 study. The results showed that, compared with chemotherapy alone, the combination therapy with Keytruda significantly improved overall survival (12.7 vs. 10.9 months; P=0.0034), achieving the primary endpoint of the study. This is also the first Phase III study of Keytruda in biliary tract cancer to be successfully completed.

Source: Lancet

BTC (including cholangiocarcinoma and gallbladder cancer) is a group of rare and aggressive gastrointestinal cancers, as well as the second most common (the most common being hepatocellular carcinoma) primary liver cancer, accounting for 15% of all liver cancers. It is estimated that there are approximately 210,000 new cases of BTC diagnosed globally each year, along with 170,000 deaths. Due to the typically asymptomatic nature of this disease in its early stages, the majority (70%) of patients are diagnosed at an advanced stage, leaving limited treatment options and a poor prognosis. Only about 5%-15% of patients survive five years.

As of now, six products have been approved for the treatment of BTC, but only durvalumab is used as a first-line regimen. Additionally, durvalumab was the first immunotherapy approved for the treatment of BTC.

Another 18 products are in Phase III studies, but only Keytruda (Merck & Co., Inc.), Envafolimab (Alphamab Oncology), Tegafur-Gimeracil-Oteracil Potassium (Taiho), Toripalimab (Junshi Biosciences), and NUC-1031 (NuCana) have developed first-line regimens. Among them, Tegafur-Gimeracil-Oteracil Potassium has completed two Phase III studies (first-line treatment).

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