Market Spotlight: Sarcoma
Market Spotlight: Sarcoma
This Market Spotlight report covers the Sarcoma market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
This Market Spotlight report covers the Sarcoma market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, patent information, probability of success, recent events and analyst opinion, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
- Datamonitor Healthcare estimates that in 2017, there were approximately 413,300 incident cases of sarcoma worldwide, and forecasts that number to increase to 485,100 incident cases by 2026.
- Worldwide, the majority of sarcoma cases were soft tissue and other extraosseous sarcomas (83%), while a smaller proportion were osteosarcomas and other malignant bone tumors (17%).
- The approved drugs in the sarcoma space focus on a wide variety of targets. The majority of approved drugs are administered via the intravenous route, with two products being available in oral formulations.
- The majority of industry-sponsored drugs in active clinical development for sarcoma are in Phase II, with only one drug in the NDA/BLA stage.
- Therapies in development for sarcoma focus on a wide variety of targets. The majority of these therapies are administered via the oral and intravenous routes, with the remainder being intraocular, subretinal, subconjunctival, intradermal, intramuscular, intraarterial, intratumoral, and topical formulations.
- An expected PDUFA date for tazemetostat is the only high-impact upcoming event in the sarcoma space. The overall likelihood of approval of a Phase I sarcoma asset is 10.9%, and the average probability a drug advances from Phase III is 50%. 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 17 licensing and asset acquisition deals involving sarcoma drugs during 2014–19. The largest deal during the period was the $1,150m strategic collaboration and licensing agreement signed in 2014 between Adaptimmune and GlaxoSmithKline to develop and commercialize Adaptimmune’s NY-ESO-1 program.
- The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for sarcoma have been in the early and mid-phases of development, with 89% of trials in Phase I–II, and only 11% in Phase III–IV.
- The US has a substantial lead in the number of sarcoma clinical trials globally. France leads the major EU markets, while Israel has the top spot in Asia.
- Clinical trial activity in the sarcoma space is dominated by completed trials. Merck & Co and Novartis have the highest number of completed clinical trials for sarcoma, with 16 trials each.
- Merck & Co leads industry sponsors with the highest overall number of clinical trials for sarcoma, followed by Novartis.
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
9 Radiation therapy
9 Targeted therapies
11 Epidemiological disease definition
17 MARKETED DRUGS
19 PIPELINE DRUGS
31 RECENT EVENTS AND ANALYST OPINION
31 NKTR-214 for Sarcoma (June 3, 2019)
32 Tazemetostat for Sarcoma (June 3, 2019)
34 Lartruvo for Sarcoma (June 2, 2019)
36 Lartruvo for Sarcoma (January 18, 2019)
37 Beleodaq for Sarcoma (January 17, 2019)
38 Tazemetostat for Sarcoma (September 24, 2018)
39 Yondelis for Sarcoma (June 4, 2018)
41 Selinexor for Sarcoma (June 1, 2018)
42 Tazemetostat for Sarcoma (April 23, 2018)
44 KEY UPCOMING EVENTS
45 KEY REGULATORY EVENTS
45 Epizyme Banks On ORR For Tazemetostat Accelerated Approval
45 Celgene Eyes Late 2019 Kaposi Sarcoma Submission For Pomalyst Following BTD
45 Nanobiotix’s Hensify Earns CE Mark For Soft-Tissue Sarcoma
45 EU Safety Review Starts For Oral Anticoagulants
45 Lilly’s Lartruvo Could Be Headed For Rare Accelerated Approval Withdrawal
46 No New Patients For Lartruvo In EU After Trial Failure
47 PROBABILITY OF SUCCESS
48 LICENSING AND ASSET ACQUISITION DEALS
48 Bayer Bags Full Vitrakvi Rights As Lilly Signs Off Loxo Buy
49 PARENT PATENTS
50 REVENUE OPPORTUNITY
51 CLINICAL TRIAL LANDSCAPE
52 Sponsors by status
53 Sponsors by phase
54 Recent events
56 Prescription information
LIST OF FIGURES
14 Figure 1: Trends in incident cases of sarcoma, 2017–26
15 Figure 2: Incident cases of sarcoma, by age, 2017
16 Figure 3: Incident cases of sarcoma, by tumor type, 2017
19 Figure 4: Overview of pipeline drugs for sarcoma in the US
20 Figure 5: Pipeline drugs for sarcoma, by company
20 Figure 6: Pipeline drugs for sarcoma, by drug type
20 Figure 7: Pipeline drugs for sarcoma, by classification
32 Figure 8: NKTR-214 for Sarcoma (June 3, 2019): Phase II – w/Nivolumab
34 Figure 9: Tazemetostat for Sarcoma (June 3, 2019): Phase II – INI1-Negative Tumors
36 Figure 10: Lartruvo for Sarcoma (June 2, 2019): Phase III – ANNOUNCE (w/Doxorubicin)
41 Figure 11: Yondelis for Sarcoma (June 4, 2018): Phase III – TSAR
42 Figure 12: Selinexor for Sarcoma (June 1, 2018): Phase II/III – SEAL
44 Figure 13: Key upcoming events in sarcoma
47 Figure 14: Probability of success in the sarcoma pipeline
48 Figure 15: Licensing and asset acquisition deals in sarcoma, 2014–19
49 Figure 16: Parent patents in sarcoma
51 Figure 17: Clinical trials in sarcoma
51 Figure 18: Top 10 drugs for clinical trials in sarcoma
52 Figure 19: Top 10 companies for clinical trials in sarcoma
52 Figure 20: Trial locations in sarcoma
53 Figure 21: Sarcoma trials status
54 Figure 22: Sarcoma trials sponsors, by phase
LIST OF TABLES
13 Table 1: Incident cases of sarcoma, 2017–26
18 Table 2: Marketed drugs for sarcoma
22 Table 3: Pipeline drugs for sarcoma in the US
31 Table 4: NKTR-214 for Sarcoma (June 3, 2019)
33 Table 5: Tazemetostat for Sarcoma (June 3, 2019)
35 Table 6: Lartruvo for Sarcoma (June 2, 2019)
37 Table 7: Lartruvo for Sarcoma (January 18, 2019)
38 Table 8: Beleodaq for Sarcoma (January 17, 2019)
39 Table 9: Tazemetostat for Sarcoma (September 24, 2018)
40 Table 10: Yondelis for Sarcoma (June 4, 2018)
41 Table 11: Selinexor for Sarcoma (June 1, 2018)
43 Table 12: Tazemetostat for Sarcoma (April 23, 2018)
50 Table 13: Historical global sales, by drug ($m), 2014–18
50 Table 14: Forecasted global sales, by drug ($m), 2019–23
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