Daiichi Sankyo has reported data from the Phase II VALENTINE-PTCL01 clinical trial where Ezharmia (valemetostat tosilate) offered durable responses in relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL) patients.
The two-cohort, open-label, international, single-arm trial analysed the safety and efficacy of Ezharmia in r/r PTCL patients and those with adult T-cell leukaemia/ lymphoma (ATLL) at 60 study centres in North America, Asia, Oceania and Europe.
These subjects previously received a minimum of one systemic treatment and were not eligible for a haematopoietic cell transplant.
Objective response rate (ORR) is the primary endpoint of the trial while secondary endpoints include duration of response (DoR), complete responses (CRs) and partial response (PR) among others.
Treatment with Ezharmia led to an objective response rate (ORR) of 43.7%.
Furthermore, 17 CRs and 35 PRs were reported in the trial with a median DoR of 11.9 months after 9.7 months of median follow-up.
After 11.3 months of the median follow-up period, treatment with Ezharmia led to 5.5 months of median progression-free survival (PFS).
Furthermore, the median OS was 17 months following a median follow-up of 12.3 months.
Ezharmia’s safety profile in the trial was in line with prior clinical studies.
An EZH1 and EZH2 inhibitor, Ezharmia received approval in Japan to treat r/r ATLL earlier.
The company plans to submit a supplemental new drug application for the therapy in the region in the second half of the current fiscal year.
Daiichi Sankyo R&D global head Ken Takeshita said: “The results of VALENTINE-PTCL01 support the potential of Ezharmia as a novel single agent therapy across subtypes of previously treated peripheral T-cell lymphomas.
“The response rate reported and duration of response of nearly one year seen in the study is impressive for this historically difficult-to-treat blood cancer with limited available treatment options.”
In September 2023, the company reported positive data from the Phase III TROPION-Breast01 trial of datopotamab deruxtecan (Dato-DXd) for hormone receptor (HR)-positive, HER2-low or negative breast cancer.
