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The oral report of ASH 2021 features positive phase 2 data from Japanese patients with relapsed/refractory ATL
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In fiscal 2021, Japan has obtained orphan drug qualification through regulatory filing
Daiichi Sankyo Company, Limited (hereinafter referred to as Daiichi Sankyo) announced that valmetastat is a potential first-in-class EZH1 and EZH2 dual inhibitor, which has been demonstrated in a key phase 2 study of relapsed/refractory adult T cell patients in Japan. The desired remission rate is leukemia/lymphoma (ATL).The results are reported today in 63’s oral report (#303)road American Society of Hematology Annual Meeting (#ASH21).
Although ATL is a rare disease, it occurs more frequently in parts of Japan and other regions.1 Currently, there is no best standard treatment plan for ATL.1 Nearly 90% of patients will relapse after intensive first-line treatment, and there are few options available at this time.1,2
The phase 2 study of valmetostat reached its primary endpoint. As assessed by the independent efficacy evaluation committee, the objective response rate (ORR) of 25 patients with relapsed/refractory ATL was 48% (90% CI: 30.5%-65.9) %). 5 cases of complete remission, 7 cases of partial remission and 10 cases of stable disease were reported. At a median follow-up of 6.5 months, the median duration of response (DOR) was not reached (95% CI: 1.87 months-NR). As of the data cutoff on April 24, 2021, there are still 8 patients still receiving treatment.
The safety of valmestat in the study is consistent with a phase 1 trial of patients with a variety of non-Hodgkin’s lymphomas, including peripheral T-cell lymphoma (PTCL) and ATL.3 Fifteen of 25 patients (60%) had a Grade 3 or higher treatment emergency adverse event (TEAE), the most common of which (occurring in ≥30% of patients) was a decrease in platelet count (80%) , Anemia (48%), hair loss (40%) and dysgeusia (36%). Twenty percent (n=5) and 8% (n=2) of patients interrupted or reduced their dose due to TEAE, respectively. Two patients (8%) discontinued treatment due to TEAE.
Based on these data, valmetolstat was granted orphan drug designation by the Ministry of Health, Labour and Welfare (MHLW) of Japan for the treatment of relapsed/refractory ATL. Therapies that have been granted orphan drug designation by the Ministry of Health and Welfare of Japan are therapies developed for serious, difficult-to-treat diseases that affect less than 50,000 patients in Japan. They are eligible for a number of measures designed to support development, including but not limited to guidance and Subsidies for R&D activities, priority consultation for clinical development, and priority review of applications.
“The phase 2 trial of varmetostat has shown that in Japanese patients with a history of Mogamulizumab for relapsed/refractory ATL, the response rate is encouraging,” said Makoto Yoshimitsu, MD and MD. Associate Professor, Kagoshima University Hospital, Japan. “For Japanese patients with aggressive ATL subtypes, even with intensive chemotherapy, the median overall survival is about 12 months. There is a great need for potential new options such as valmetastat to improve outcomes, especially in In a relapsed/refractory environment.”4
“Based on these key data of valmestat, the dual targeting of EZH1 and EZH2, which play an important role in the pathophysiology of T-cell lymphoma, appears to be the treatment of relapsed/refractory ATL (a type of PTCL, especially with poor prognosis, Said Ken Takeshita, MD, global head of Daiichi Sankyo Research and Development. “We are working hard to provide valmestat for ATL patients in Japan as soon as possible, while continuing our global development in T-cell and B-cell lymphoma.”
The study also showed that the measurable lesions of all evaluated disease sites (including lymph nodes, extranodal, skin, and peripheral blood) have a tendency to decrease.
The trial included patients with three aggressive ATL subtypes who received a median of 3 previous treatments (range, 1-8). 24 of the 25 patients had received pre-treatment with Mogamulizumab.
Summary of Phase 2 Results
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Efficacy measurement* |
All patients (n=25) |
acute (n=16) |
Lymphoma (n=6) |
Unfavorable chronic (n=3) |
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The full story can be found on Benzinga.com
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