Japan Approves Daiichi Sankyo's Peripheral T-Cell Lymphoma Therapy

Daiichi Sankyo has received approval from the Japan Ministry of Health, Labour and Welfare for their drug EZHARMIA (valemetostat tosilate) to treat relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL). Notably, EZHARMIA is the first dual EZH1 and EZH2 inhibitor to be approved for this specific medical condition.

The approval of EZHARMIA follows the promising results from the VALENTINE-PTCL01 Phase II trial, an international, open-label, single-arm, two-cohort study. This trial evaluated the drug's efficacy and safety in patients with relapsed or refractory PTCL and adult T-cell leukemia/lymphoma who had already undergone at least one systemic therapy but were not eligible for a hematopoietic stem cell transplant at the time of screening. The trial enrolled 133 patients across various locations in Europe, Asia, North America, and Oceania.

The primary endpoint of the study was the objective response rate (ORR), with secondary endpoints including duration of response, complete response (CR), partial response (PR), duration of CR, progression-free survival, overall survival, safety, and pharmacokinetics. The results were encouraging; EZHARMIA achieved an ORR of 43.7% among the 119 efficacy-evaluable patients with relapsed or refractory PTCL. Moreover, the treatment induced 17 complete responses and 35 partial responses, demonstrating effectiveness across different PTCL subtypes, such as angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified.

Toshinori Agatsuma, the head of Daiichi Sankyo's research and development division in Japan, commented on the significance of this approval. He emphasized that this second indication for EZHARMIA in Japan represents a crucial advancement for the treatment of relapsed or refractory PTCL, highlighting the urgent need for new and effective treatment options to improve patient outcomes. Agatsuma added that EZHARMIA is a testament to the innovative research efforts by Daiichi Sankyo, which aim to develop new medications capable of transforming the standard of care for cancer patients.

This approval underscores the evolving landscape of cancer treatment, where targeted therapies like EZHARMIA offer new hope for patients with challenging conditions such as relapsed or refractory PTCL. By focusing on dual inhibition of EZH1 and EZH2, Daiichi Sankyo has introduced a novel mechanism of action that has shown promising efficacy and safety profiles, contributing to the broader arsenal of treatments available for PTCL.

In conclusion, Daiichi Sankyo's EZHARMIA has marked a significant milestone in cancer therapy by securing approval from the Japan Ministry of Health, Labour and Welfare for the treatment of relapsed or refractory PTCL. The robust results from the VALENTINE-PTCL01 Phase II trial provide a strong foundation for this approval, offering a new therapeutic option for patients in dire need of effective treatments. This development is a step forward in the ongoing quest to improve outcomes for cancer patients worldwide.