Biliary tract cancer (BTC), also known as cholangiocarcinoma or bile duct adenocarcinoma, is a cancer that originates from the cells which line the bile duct. These are a group of rare and heterogeneous malignancies with poor prognosis. BTCs are genetically and clinically divergent.
Key Takeaways
Key Takeaways
- The publisher estimates that in 2019, there were approximately 405,800 incident cases of biliary tract cancer (BTC) worldwide, and forecasts that number to increase to 433,300 incident cases by 2028.
- The only approved drug in the BTC space is Pemazyre, which targets fibroblast growth factor receptor. It is administered via the oral route.
- The majority of industry-sponsored drugs in active clinical development for BTC are in Phase II, with one drug in the NDA/BLA stage.
- Therapies in development for BTC focus on a wide variety of targets, with the majority being administered via the oral or intravenous routes.
- High-impact upcoming events for drugs in the BTC space comprise topline Phase II trial results for M7824 and fimaCHEM, topline Phase IIa trial results for Xermelo, topline Phase IIb/III trial results for surufatinib, topline Phase III trial results for Imfinzi, an expected CHMP opinion for Pemazyre, and an estimated PDUFA date for infigratinib.
- The overall likelihood of approval of a Phase I solid tumors asset is 5.5%, and the average probability a drug advances from Phase III is 42.7%. Drugs, on average, take 9.7 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
- The distribution of clinical trials across Phase I-IV indicates that the vast majority of trials for biliary tract neoplasms have been in the early and mid-phases of development, with 91% of trials in Phase I-II, and only 9% in Phase III-IV.
- The US has a substantial lead in the number of biliary tract neoplasms clinical trials globally. The UK leads the major European markets, while South Korea has the top spot in Asia.
- Eli Lilly has the highest number of completed clinical trials for biliary tract neoplasms, with five trials.
- AstraZeneca leads industry sponsors with the highest overall number of clinical trials for biliary tract neoplasms.
Table of Contents
OVERVIEWKEY TAKEAWAYSEPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGSKEY UPCOMING EVENTSPROBABILITY OF SUCCESSREVENUE OPPORTUNITYBIBLIOGRAPHYAPPENDIX
DISEASE BACKGROUND
TREATMENT
RECENT EVENTS AND ANALYST OPINION
KEY REGULATORY EVENTS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
LIST OF FIGURES
LIST OF TABLES
