Market Spotlight: Gastrointestinal Stromal Tumor (GIST)

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Report
32 Pages
May 2021
Region: Global
Citeline
ID: 4533507

This Market Spotlight report covers the Gastrointestinal Stromal Tumor (GIST) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, regulatory events, probability of success, a 10-year disease incidence forecast, and drug-specific revenue forecasts.

Key Takeaways

The publisher 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, plateletderived growth factor alpha, PPAR gamma, Raf kinase, VEGF receptor, and FMS-like tyrosine kinase 3. These therapies are administered via the oral route.
Industry-sponsored drugs in active clinical development for GIST are spread evenly across Phase I and Phase II, with one drug in Phase III.
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 intratumoral and intravenous formulations.
The only high-impact upcoming event in the GIST space is topline Phase III trial results for Qinlock. The overall likelihood of approval of a Phase I solid tumors asset is 5.3%, and the average probability a drug advances from Phase III is 42.8%. 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 majority of trials for GIST have been in the early and midphases of development, with 83% of trials in Phase I–II, and only 17% 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 65 trials.
Novartis leads industry sponsors with by far the highest overall number of clinical trials for GIST.

OVERVIEWKEY TAKEAWAYSDISEASE BACKGROUND

TREATMENT

Surgery
Targeted therapy
Other treatments

EPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

Ayvakit for GIST (April 28, 2020)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

FDA Approval Makes Deciphera’s Qinlock First Fourth-Line GIST Drug
CRL Marks End Of Ayvakit’s Voyage To Broad GIST Claim

PROBABILITY OF SUCCESSREVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

Sponsors by status
Sponsors by phase

BIBLIOGRAPHYAPPENDIX

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: Ayvakit for GIST (April 28, 2020): Phase III - VOYAGER
Figure 7: Key upcoming events in GIST
Figure 8: Probability of success in the solid tumors pipeline
Figure 9: Clinical trials in GIST
Figure 10: Top 10 drugs for clinical trials in GIST
Figure 11: Top 10 companies for clinical trials in GIST
Figure 12: Trial locations in GIST
Figure 13: GIST trials status
Figure 14: 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: Ayvakit for GIST (April 28, 2020)
Table 6: Historical global sales, by drug ($m), 2016–20
Table 7: Forecasted global sales, by drug ($m), 2021–25

Table of Contents

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