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.
Datamonitor Healthcare 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
- Radiation therapy
- Targeted therapy
- Palliative therapy
RECENT EVENTS AND ANALYST OPINION
- Futibatinib for BTC (April 11, 2021)
- Bintrafusp Alfa for BTC (March 16, 2021)
- Tibsovo for BTC (January 17, 2021)
- Tibsovo for BTC (September 21, 2020)
- Varlitinib for BTC (November 11, 2019)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Japan Approves Incyte's Pemazyre for Unresctable BTC
- Real-Time Review: Danyelza, Gavreto Graduate; infigratinib Joins Up
- Merck KGaA Rebounds After COVID-19 Lockdowns
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Agios Sells Cancer Portfolio To Servier To Focus On Genetic Diseases
- Lexicon Sells Cancer Supportive Care Therapy To TerSera
- Sirnaomics To Use Precision NanoSystems Technology To Advance Pipeline
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
LIST OF FIGURES
- Figure 1: Trends in incident cases of BTC, 2019-28
- Figure 2: Overview of pipeline drugs for BTC in the US
- Figure 3: Pipeline drugs for BTC, by company
- Figure 4: Pipeline drugs for BTC, by drug type
- Figure 5: Pipeline drugs for BTC, by classification
- Figure 6: Bintrafusp Alfa for BTC (March 16, 2021): Phase II - INTR@PID BTC 047 (2nd Line)
- Figure 7: Tibsovo for BTC (January 17, 2021): Phase III - ClarIDHy
- Figure 8: Tibsovo for BTC (September 21, 2020): Phase III - ClarIDHy
- Figure 9: Varlitinib for BTC (November 11, 2019): Phase II/III - TreeTopp
- Figure 10: Key upcoming events in BTC
- Figure 11: Probability of success in the solid tumors pipeline
- Figure 12: Clinical trials in biliary tract neoplasms
- Figure 13: Top 10 drugs for clinical trials in biliary tract neoplasms
- Figure 14: Top 10 companies for clinical trials in biliary tract neoplasms
- Figure 15: Trial locations in biliary tract neoplasms
- Figure 16: Biliary tract neoplasms trials status
- Figure 17: Biliary tract neoplasms trials sponsors, by phase
LIST OF TABLES
- Table 1: Incident cases of BTC, 2019-28
- Table 2: Marketed drugs for BTC
- Table 3: Pipeline drugs for BTC in the US
- Table 4: Futibatinib for BTC (April 11, 2021)
- Table 5: Bintrafusp Alfa for BTC (March 16, 2021)
- Table 6: Tibsovo for BTC (January 17, 2021)
- Table 7: Tibsovo for BTC (September 21, 2020)
- Table 8: Varlitinib for BTC (November 11, 2019)
- Table 9: Historical global sales, by drug ($m), 2016-20
- Table 10: Forecasted global sales, by drug ($m), 2021-25