Product Code: DMKC0182656
This Market Spotlight report covers the Gastrointestinal Stromal Tumor (GIST) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, patent information, a 10-year disease incidence forecast, licensing and asset acquisition deals, and drug-specific revenue forecasts.
- Datamonitor Healthcare estimates that in 2019, there were 100,200 incident cases of gastrointestinal stromal tumor (GIST) worldwide, and expects that number to increase to 109,000 incident cases by 2028. The approved drugs in the GIST space target BCR-ABL fusion protein, KIT/c-KIT, platelet-derived growth factor receptor, Raf kinase, VEGF receptor, and FMS-like tyrosine kinase 3. These therapies are administered via the oral route.
- The largest proportion of industry-sponsored drugs in active clinical development for GIST are in Phase II, with one drug in the NDA/BLA phase.
- Therapies in development for GIST focus on a wide variety of targets. The majority of pipeline drugs in development are administered orally, with the remainder being tested in intravenous formulations.
- High-impact upcoming events in the GIST space comprise an expected PDUFA date for ripretinib; and topline Phase III trial results, an expected PDUFA date, as well as a CHMP opinion for Ayvakit.
- The overall likelihood of approval of a Phase I solid tumors asset is 5.7%, and the average probability a drug advances from Phase III is 41.9%. Drugs, on average, take 9.4 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
- There have been only four licensing and asset acquisition deals involving GIST drugs during 2015-20. The exclusive collaboration and licensing agreement for $386m signed in June 2018 between Blueprint and CStone to develop and commercialize avapritinib, BLU-554, and BLU-667 in mainland China, Hong Kong, Macau, and Taiwan, either as monotherapies or combination therapies, was the largest deal.
- The distribution of clinical trials across Phase I-IV indicates that the majority of trials for GIST have been in the early and midphases of development, with 82% of trials in Phase I-II, and only 18% in Phase III-IV.
- The US has a substantial lead in the number of GIST clinical trials globally. France leads the major European markets, while China has the top spot in Asia.
- Clinical trial activity in the GIST space is dominated by completed trials. Novartis has the highest number of completed clinical trials for GIST, with 63 trials.
- Novartis leads industry sponsors with by far the highest overall number of clinical trials for GIST.
TABLE OF CONTENTS
- Targeted therapy
- Other treatments
RECENT EVENTS AND ANALYST OPINION
- Ripretinib for GIST (August 13, 2019)
- Mektovi for GIST (June 17, 2019)
- Ripretinib for GIST (June 11, 2019)
- Cabometyx / Cometriq for GIST (June 3, 2019)
- Ayvakit for GIST (November 15, 2018)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Finance Watch: Revolution Medicines Continues 2020's Post-IPO Trend
- Blueprint Medicines Gains US Approval For First Drug, Precision Medicine Ayvakit
- Blueprint Medicines Aims For Genomically Defined GIST Indication With Avapritinib NDA
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Deciphera Grants Zai Exclusive Ripretinib Rights In Greater China
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
LIST OF FIGURES
- Figure 1: Trends in incident cases of GIST, 2019-28
- Figure 2: Overview of pipeline drugs for GIST in the US
- Figure 3: Pipeline drugs for GIST, by company
- Figure 4: Pipeline drugs for GIST, by drug type
- Figure 5: Pipeline drugs for GIST, by classification
- Figure 6: Ripretinib for GIST (August 13, 2019): Phase III - INVICTUS
- Figure 7: Ayvakit for GIST (November 15, 2018): Phase I - NAVIGATOR
- Figure 8: Key upcoming events in GIST
- Figure 9: Probability of success in the GIST pipeline
- Figure 10: Licensing and asset acquisition deals in GIST, 2015-20
- Figure 11: Parent patents in GIST
- Figure 12: Clinical trials in GIST
- Figure 13: Top 10 drugs for clinical trials in GIST
- Figure 14: Top 10 companies for clinical trials in GIST
- Figure 15: Trial locations in GIST
- Figure 16: GIST trials status
- Figure 17: GIST trials sponsors, by phase
LIST OF TABLES
- Table 1: Incident cases of GIST, 2019-28
- Table 2: Incidence of GIST
- Table 3: Marketed drugs for GIST
- Table 4: Pipeline drugs for GIST in the US
- Table 5: Ripretinib for GIST (August 13, 2019)
- Table 6: Mektovi for GIST (June 17, 2019)
- Table 7: Ripretinib for GIST (June 11, 2019)
- Table 8: Cabometyx / Cometriq for GIST (June 3, 2019)
- Table 9: Ayvakit for GIST (November 15, 2018)
- Table 10: Historical global sales, by drug ($m), 2014-18
- Table 11: Forecasted global sales, by drug ($m), 2020-24