HUTCHMED(00013) initiates Phase III clinical trial of HMPL-760 for the treatment of relapsed/refractory diffuse large B-cell lymphoma in China.

HUTCHMED (00013) announced today that the company has initiated a phase III registration clinical trial in China for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients with the HMPL-760 combination R-GemOx regimen (rituximab, gemcitabine, and oxaliplatin). The first patient received their first dose of treatment on March 20, 2026. DLBCL is the most common aggressive non-Hodgkin lymphoma globally, accounting for approximately 40% of all non-Hodgkin lymphoma cases in China. It is estimated that there will be around 81,000 new cases of non-Hodgkin lymphoma in China in 2022. Bruton's tyrosine kinase (BTK) is considered a validated drug target for treating certain blood cancers. HMPL-760 is an efficient, selective, and reversible BTK inhibitor that can bind to the target for a long time, including wild-type and C481S mutated BTK. The study is a randomized, double-blind, positive-controlled phase III clinical trial designed to evaluate the efficacy, safety, and pharmacokinetics of the HMPL-760 combination R-GemOx regimen compared to the placebo combined with RGemOx regimen in patients with relapsed or refractory DLBCL who have previously received first-line systemic therapy, immunotherapy, or immunotherapy combined therapy and are not suitable for transplantation. The primary endpoint of the study includes investigator-assessed progression-free survival (PFS) and overall survival (OS). Secondary endpoints include PFS assessed by an Independent Review Committee (IRC), objective response rate (ORR) and complete response rate (CRR) assessed by IRC and investigators, duration of response (DoR), clinical benefit rate (CBR), time to response (TTR), safety, and pharmacokinetic characteristics. The registration clinical trial plans to enroll approximately 240 patients, with the principal investigator being Professor Weili Zhao, Vice President of Renji Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, and Director of the Shanghai Institute of Hematology.