- The author estimates that in 2016, there were approximately 403,000 incident cases of sarcoma worldwide, and forecasts that number to increase to 473,700 incident cases by 2025.
- Worldwide in 2016, the majority of sarcoma cases were soft tissue and other extraosseous sarcomas (~85%), while a smaller proportion were osteosarcomas and other malignant bone tumors (~15%).
- The approved drugs in the sarcoma space focus on targets such as tumor necrosis factor-alpha, microtubules, platelet-derived growth factor receptor, vascular endothelial growth factor receptor, KIT/c-KIT, and DNA. All of the approved drugs are administered via the intravenous route, except for one drug which is available in an oral formulation.
- The majority of industry-sponsored drugs in active clinical development for sarcoma are in Phase II. 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, intratumoral, and topical formulations.
- High impact upcoming events in the sarcoma space include topline Phase II trial results for NY-ESO-1(C259), and topline Phase III trial results for TRC105 and Nirogacestat.
- There have been 14 licensing and asset acquisition deals involving sarcoma drugs during 2013-18. The licensing agreement between Adaptimmune and GlaxoSmithKline in 2014 for $1,150m to develop and commercialize NY-ESO-1(C259) was the largest deal.
- Votrient sales ranked highest among drugs approved for sarcoma during 2012-16, and its sales are forecasted to remain high through 2022.
- The distribution of clinical trials across Phase I-IV indicates that the majority of trials for sarcoma have been in the early and midphases of development, with 90.7% of trials in Phase I-II, and only 9.3% in Phase III-IV.
- The US has a substantial lead in the number of sarcoma clinical trials globally, while France leads the major EU markets. 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 14 trials each.
- Merck & Co leads industry sponsors with the highest number of clinical trials for sarcoma, followed by Novartis and Pfizer.
Osteosarcomas and malignant bone tumors
Soft tissue and other extraosseous sarcomas
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
Lilly's Sarcoma Drug Likely To Be Used Widely Despite EU Conditional OK
LICENSING AND ASSET ACQUISITION DEALS
NantCell gets exclusive aldoxorubicin rights from CytRx
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
List of Figures
Figure 1: Trends in incident cases of sarcoma, 2016-25
Figure 2: Incident cases of sarcoma, by age, 2016
Figure 3: Incident cases of sarcoma, by tumor type, 2016
Figure 4: Overview of pipeline drugs for sarcoma in the US
Figure 5: Pipeline drugs for sarcoma, by company
Figure 6: Pipeline drugs for sarcoma, by drug type
Figure 7: Pipeline drugs for sarcoma, by classifications
Figure 8: Key upcoming events in sarcoma
Figure 9: Licensing and asset acquisition deals in sarcoma, 2013-18
Figure 10: Parent patents in sarcoma
Figure 11: Clinical trials in sarcoma
Figure 12: Top 10 drugs for clinical trials in sarcoma
Figure 13: Top 10 companies for clinical trials in sarcoma
Figure 14: Trial locations in sarcoma
Figure 15: Sarcoma trials status
Figure 16: Sarcoma trials sponsors, by phase
List of Tables
Table 1: Incident cases of sarcoma, 2016-25
Table 2: Marketed drugs for sarcoma
Table 3: Approvals by country for sarcoma
Table 4: Pipeline drugs for sarcoma in the US
Table 5: Historical global sales, by drug ($m), 2012-16
Table 6: Forecasted global sales, by drug ($m), 2017-22