Lymphoma maintenance therapy delivers promise in CTCL

03 October 2023

Catherine Eckford / European Pharmaceutical Review

One of the largest clinical trials in cutaneous T-cell lymphoma (CTCL) to date could change current clinical practice, new data shows.

Resminostat (Kinselby) has been clinically proven to postpone disease progression, new data from one of the largest clinical trials in cutaneous T-cell lymphoma (CTCL) to date has revealed.

The treatment is an oral small molecule class I, IIb and IV histone deacetylase (HDAC) inhibitor.

Data from the RESMAIN resminostat study

Findings from the RESMAIN study of the maintenance therapy could significantly change clinical practice in advanced CTCL, according to the company.

Findings from the RESMAIN study of the maintenance therapy could significantly change clinical practice in advanced CTCL”

A 97.6 percent improvement in progression free survival (PFS) was observed in comparison to placebo. A risk reduction of 38 percent was also achieved in the trial. Median PFS was 8.3 months versus 4.2 months.

Moreover, with resminostat (Kinselby), the median time to next treatment versus placebo showed a significant improvement of 8.8 months compared to 4.2 months.

Additional analyses also established that patients in the study showed a clinically meaningful improvement in median ‘total’ PFS of 24.3 months. This was compared to 14.9 months for participants in the placebo group. A significant delay in the development of new, or worsening of existing, skin tumours was also noted.

RESMAIN study of resminostat (Kinselby) enrolled 201 patients. Patients who experienced disease progression while having a placebo treatment were offered resminostat in an open label treatment arm.

“Positive data from the RESMAIN study demonstrate that resminostat (Kinselby) is effective in significantly slowing disease progression in CTCL patients,” commented Jason Loveridge, PhD, CEO of 4SC. As the only proven maintenance therapy for CTCL, resminostat offers “significant benefits for patients who would otherwise have no other similar treatment options available to them,” Loveridge added.

The data from the resminostat study was presented at the 2023 EORTC Cutaneous Lymphoma Tumour Group Annual Meeting, at the Leiden University Medical Center Amsterdam.

In terms of drug development, the company stated that filing for marketing approval of the oral small molecule treatment in the EU, Switzerland and UK is planned for Q1 2024.



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