NEW YORK – Daiichi Sankyo and Europe's largest lymphoma research network, LYSA-LYSARC-CALYM, said on Wednesday that they will collaborate on a clinical trial evaluating Daiichi Sankyo's anti-EZH1/2 agent valemetostat for patients with five different types of relapsed or refractory B-cell lymphomas.
The Phase II trial, which is expected to begin this year, will enroll roughly 140 patients across six subtype-specific cohorts. The cohorts will include patients with diffuse large B-cell lymphoma with and without EZH2 mutations, follicular lymphomas with and without EZH2 mutations, mantle cell lymphoma, Hodgkin lymphoma, and marginal zone lymphoma or other indolent lymphomas.
The study's primary goal is to evaluate best overall response rates, and the secondary endpoints include patients' complete response rates, progression-free survival, duration of response, time to response, and the safety of valemetostat. The investigators will also consider exploratory endpoints, including overall survival and pharmacokinetic endpoints, as well as patients' treatment response based on biomarker expression.
For its part of the collaboration, LYSA-LYSARC-CALYM — made up of the Lymphoma Study Association, Lymphoma Academic Research Organization, and the CALYM research consortium — will conduct the study across 22 sites in France and Belgium.
"We believe that our extensive multidisciplinary and international expertise will help advance the science behind the novel mechanism of action [of valemetostat] and we look forward to playing a role in bringing this potential new medicine to patients with lymphoma," Franck Morschhauser, president of LYSA-LYSARC, said in a statement.
Daiichi Sankyo is also evaluating valemetostat in several additional Phase I and II trials worldwide, including a pivotal Phase II trial in Japan for patients with relapsed or refractory adult T-cell leukemia/lymphoma (ATL), a Phase I study in the US and Japan for non-Hodgkin lymphomas and ATL, and a Phase I trial in the US for acute lymphoblastic leukemia and acute myeloid leukemia.