4SC: Landmark RESMAIN study data presented at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting

4SC: Landmark RESMAIN study data presented at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting

Maintenance therapy is now clinically proven to postpone disease progression in advanced CTCL which could significantly change current clinical practice

• RESMAIN is one of the largest clinical trials in cutaneous T-cell lymphoma (CTCL) to-date
• Resminostat (Kinselby) as a maintenance treatment for advanced CTCL, is clinically proven to postpone disease progression in patients – a new treatment paradigm in CTCL

o   Resminostat (Kinselby) treatment has shown a statistically significant improvement in progression free survival of 97.6% compared to placebo, with a risk reduction of 38% in recently announced headline trial results (median PFS: 8.3 months versus 4.2 months; p=0.015; HR: 0.623 (95%CI: 0.424, 0.916)

o   Resminostat (Kinselby)’s median time to next treatment (median TTNT) versus placebo showed a significant improvement, more than doubling to 8.8 months compared to 4.2 months; p= 0.002; HR: 0.594 (95% CI: 0.424, 0.916)

o   The side effects of resminostat were mainly mild to moderate, manageable and reversible

• Additional analyses showed

o    A clinically meaningful improvement in median “total” PFS (defined from start of last prior therapy to disease progression) of 24.3 months for patients treated with resminostat, compared to 14.9 months for those in the placebo group

o    That resminostat (Kinselby) significantly delayed the development of new, or worsening of existing, skin tumours

• 4SC is actively preparing to file for its Marketing Authorization approval in the European Union, Switzerland and UK
• The Company will host a live webinar on Wednesday 4th October to discuss the findings presented at the EORTC. Dr. Susanne Danhauser-Riedl, 4SC’s Chief Medical Officer will be joined by medical experts, Professor Dr. Rudolf Stadler and Professor Julia Scarisbrick.

Planegg-Martinsried, Germany, 25 September 2023 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage CTCL, today announces that renowned dermato-oncology expert and study investigator, Professor Dr. Rudolf Stadler, University Hospital Johannes Wesling, Minden, Germany, presented positive new data from the pivotal RESMAN study of resminostat (Kinselby) at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting, at the Leiden University Medical Center Amsterdam, The Netherlands, 21-23 September.

The presented findings show that maintenance therapy is now clinically proven to postpone disease progression in advanced CTCL which could significantly change clinical practice. In RESMAIN, one of the largest randomized, controlled clinical trials in advanced CTCL, resminostat (Kinselby) treatment has shown a statistically significant improvement in progression free survival of 97.6% compared to placebo, with a risk reduction of 38% in recently announced headline trial results (median PFS: 8.3 months versus 4.2 months; p=0.015; HR: 0.623 (95%CI: 0.424, 0.916). 

Furthermore, resminostat (Kinselby)’s median time to next treatment (median TTNT) versus placebo showed a significant improvement of 8.8 months compared to 4.2 months; p= 0.002; HR: 0.594 (95% CI: 0.424, 0.916).

The side effects of resminostat were mainly mild to moderate, manageable and reversible and the known safety profile of resminostat (Kinselby) was confirmed in the RESMAIN study.

Additional analyses established that those treated showed a clinically meaningful improvement in median “total” PFS (defined from start of last prior therapy to disease progression) of 24.3 months, compared to 14.9 months for those in the placebo group. It was also noted that there was a significant delay in the development of new, or worsening of existing, skin tumours. 

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Positive data from the RESMAIN study demonstrate that resminostat (Kinselby) is effective in significantly slowing disease progression in CTCL patients. This unique treatment, which is the only proven maintenance therapy for CTCL, means that it is well placed to offer significant benefits for patients who would otherwise have no other similar treatment options available to them. 

Our focus in the near term is on the registration, approval and commercialization of Kinselby in the European Union, Switzerland and the UK and we are on track to file for European Marketing Approval of Kinselby in Q1 2024, to rapidly bring this therapy into clinical use. 4SC is well positioned for realization of resminostat (Kinselby)’s considerable value through either a sale, licensing, or partnership agreement.”

The Company will host a live webinar on Wednesday 4th October to discuss the findings presented at EORTC. Dr. Susanne Danhauser-Riedl, 4SC’s Chief Medical Officer, will be joined by medical experts, Professor Dr. Rudolf Stadler and Professor Julia Scarisbrick, who will provide further detail on these data, with the presentation being followed by the opportunity to ask questions during a Q&A session moderated by Dr. Jason Loveridge, 4SC’s Chief Executive Officer.

Title: Presentation by Professor Rudolf Stadler and Professor Julia Scarisbrick on recent new positive data from the RESMAIN study

Date and Time: Wednesday 4^th October, 3.00pm CET

Register and submit questions: https://stream.brrmedia.co.uk/broadcast/64f5f2dac6e9d7476c27f154