Biotech company 4SC has announced positive new data for its treatment for patients with advanced-stage cutaneous T-cell lymphoma (CTCL).
Findings from the RESMAIN study of 4SC’s resminostat (Kinselby) treatment show that the therapy can postpone disease progression in advanced CTCL. The RESMAIN study is one of the largest randomised controlled clinical trials in advanced CTCL, involving more than 50 clinical centres in Europe and Japan, alongside 201 patients. The main goal of the study was to determine whether maintenance therapy with resminostat could prolong progression-free survival.
Maintenance therapies are used to prolong the period patients are stable and where their disease is not progressing.
CTCL is a rare disease affecting around 5,000 patients in Europe each year. It is caused from malignant transformation of T-cells and primarily affects the skin, but can also target involve lymph nodes, blood and visceral organs.
CTCL is incurable and current treatments for advanced stages of the disease are limited. Patient responses to these treatments can often be short-lived. One of the key challenges in advanced-stage CTCL is to make remissions more durable by halting disease progression and improving patients’ quality of life.
Data presented at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting in September show that resminostat (Kinselby) had a statistically significant improvement in progression free survival of 96.7% compared to a placebo. Furthermore, resminostat displayed a risk reduction of 38%.
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.
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.
Jason Loveridge, CEO of 4SC, said: “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 realiszation of resminostat (Kinselby)’s considerable value through either a sale, licensing, or partnership agreement.”
Resminostat was granted orphan drug designation (ODD) for CTCL by the US FDA in September.
Speaking about the decision, Jason Loveridge, CEO of 4SC, added: “Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially seven years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby. We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024.”