4SC Files for EMA Approval of Resminostat (Kinselby) for Advanced Cutaneous T-Cell Lymphoma
Key Insights
4SC (search) AG has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for resminostat (Kinselby (search)).
The application is for the treatment of advanced-stage cutaneous T-cell lymphoma (search) (CTCL (search)) in patients who have achieved disease control with systemic therapy.
RESMAIN study data showed resminostat significantly improved progression-free survival (PFS) compared to placebo (8.3 vs. 4.2 months; p=0.015; HR: 0.623).
4SC (search) AG has announced the filing of its Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for resminostat (Kinselby (search)), an oral histone deacetylase (HDAC (search)) inhibitor, for the treatment of advanced-stage cutaneous T-cell lymphoma (search) (CTCL (search)). The EMA has accepted the MAA for examination, marking a significant step toward potential approval of this novel maintenance therapy.
The application is supported by data from the pivotal RESMAIN study, a randomized, placebo-controlled trial involving 201 patients with advanced-stage CTCL (search) who had achieved disease control with prior systemic therapy. Patients were randomized 1:1 to receive either resminostat or placebo as maintenance treatment.
RESMAIN Study Results
The RESMAIN study demonstrated a statistically significant improvement in progression-free survival (PFS) for patients receiving resminostat compared to placebo. The median PFS was 8.3 months in the resminostat arm versus 4.2 months in the placebo arm (p=0.015; HR: 0.623). Additionally, the median time to next treatment was significantly longer in the resminostat group (8.8 months) compared to the placebo group (4.2 months).
Furthermore, the study showed a clinically meaningful improvement in median "total" PFS of 24.3 months for patients on resminostat, compared to 14.9 months for those in the placebo group. The side effects associated with resminostat were generally mild to moderate, manageable, and reversible.
Resminostat: A Novel Approach to CTCL Treatment
CTCL (search) is a rare malignancy of T-cells that primarily affects the skin, with approximately 5,000 new cases diagnosed in Europe each year. Advanced-stage CTCL is often incurable, and current treatment options provide limited long-term disease control. Resminostat, as a maintenance therapy, aims to prolong the period of disease stability and improve patients' quality of life.
Jason Loveridge, Ph.D., CEO of 4SC (search), stated, "The team has worked hard to successfully file the Marketing Authorisation Application for resminostat in CTCL (search) ahead of schedule. This represents a significant step forward for 4SC and a great achievement for our team as it further de-risks our resminostat program and will assist our ongoing efforts to bring this important treatment to patients suffering with this disease, commercialise the asset and create value for shareholders."
Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC (search)) inhibitor that potentially offers an approach to treating different kinds of cancer. Resminostat demonstrated that it is well tolerated and can inhibit tumor growth and proliferation, cause tumor regression, and strengthen the body’s immune response to cancer. Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (search) (CTCL (search)) as maintenance treatment by 4SC (search) in Europe and by Yakult Honsha in Japan.