Clinical Trials

Daiichi Sankyo has announced results from the phase 2 VALENTINE-PTCL01 trial of Ezharmia (valemetostat tosilate), which demonstrated a clinically meaningful and durable response in patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL).

The data has been presented at an oral session at the 2023 American Society of Hematology (ASH23) annual meeting.

The drug had an objective response rate (ORR) of 43.7% in 119 patients with R/R PRCL. There were 17 complete responses and 35 partial responses throughout the trial, with a median duration of response of 11.9 months after a median follow-up of 9.7 months. A median progression-free survival of 5.5 months was seen after a median follow-up of 11.3 months and a median overall survival of 17 months was noted after a median follow-up of 12.3 months.

StevenMHorowitzMD, departmentofMedicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, US, commented: “The high response rates and durability of responses observed with valemetostat in patients with R/R PTCL are very encouraging. Relapse is too frequent in PTCL and there is an acute need for new medicines beyond standard chemotherapy to better control the disease in the relapsed or refractory setting and improve patient outcomes.”

Ken Takeshita MD, global head of R&D at Daiichi Sankyo, added: “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.”