- The author estimates that in 2016, there were approximately 13,600 incident cases of cutaneous T-cell lymphoma (CTCL) worldwide, and forecasts that number to increase to 16,100 incident cases by 2025.
- It is estimated that the majority of diagnosed cases were in males in 2016. Approved drugs in the CTCL space target antibody-drug conjugate, cluster of differentiation 30, TNFRSF8, microtubules, histone deacetylase, retinoid receptors, retinoid X receptors, DNA synthesis, interleukin-2, and protein synthesis. These drugs are administered via the intravenous, topical, and oral routes.
- The majority of industry-sponsored drugs in active clinical development for CTCL are in Phase II, with only one drug in NDA/BLA phase.
- Therapies in mid-to-late-stage development for CTCL focus on a wide variety of targets, with the majority being administered via the intravenous route.
- High-impact upcoming events include topline Phase II trial results for resminostat. There were 13 licensing and asset acquisition activities involving CTCL drugs during 2013-18. The exclusive acquisition agreement signed in 2016 between Medivir AB and Tetralogic Pharmaceuticals for $238m, for the acquisition of two clinicalstage oncology programs (remetinostat and birinapant), was the largest deal during the period.
- Istodax’s US parent patents (polymorph, process, and composition) are set to expire in August 2021, which will open the door to generic entries.
- The clinical trials distribution across Phase I-IV indicates that the majority of trials for CTCL have been in the early and midphases of development, with 86% of trials in Phase I-II, and only 14% in Phase III-IV.
- The US has a substantial lead in the number of CTCL clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the CTCL space is dominated by completed trials. Merck & Co, Ligand, and Takeda have the highest number of completed clinical trials for CTCL, with five trials each. Meanwhile, Celgene has six ongoing trials.
- Celgene leads industry sponsors with the highest number of clinical trials for CTCL, followed by Merck & Co and Seattle Genetics.
Approvals by country
KEY UPCOMING EVENTS
LICENSING AND ASSET ACQUISITION DEALS
Sponsors by status
Sponsors by phase
List of Figures
Figure 1: Trends in incident cases of CTCL, 2016-25
Figure 2: Incident cases of CTCL, by age, 2016
Figure 3: Overview of pipeline drugs for CTCL in the US
Figure 4: Pipeline drugs for CTCL, by company
Figure 5: Pipeline drugs for CTCL, by drug type
Figure 6: Pipeline drugs for CTCL, by classifications
Figure 7: Key upcoming events in CTCL
Figure 8: Licensing and asset acquisition deals in CTCL, 2013-18
Figure 9: Parent patents in CTCL
Figure 10: Clinical trials in CTCL
Figure 11: Top 10 drugs for clinical trials in CTCL
Figure 12: Top 10 companies for clinical trials in CTCL
Figure 13: Trial locations in CTCL
Figure 14: CTCL trials status
Figure 15: CTCL trials sponsors, by phase
List of Tables
Table 1: Incident cases of CTCL, 2016-25
Table 2: Incident cases of CTCL, by gender, 2016
Table 3: Marketed drugs for CTCL
Table 4: Approvals by country for CTCL
Table 5: Pipeline drugs for CTCL in the US
Table 6: Historical global sales, by drug ($m), 2012-16
Table 7: Forecasted global sales, by drug ($m), 2017-22