HUTCHMED (NASDAQ:HCM) announced the initiation of a registrational Phase III clinical trial for HMPL-760, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor.
The first patient was dosed on March 20, 2026, in a study evaluating the efficacy and safety of HMPL-760 in combination with the R-GemOx regimen (rituximab, gemcitabine, and oxaliplatin) for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The randomized, double-blind, placebo-controlled study (NCT07409428) is designed to enroll approximately 240 patients across multiple clinical sites in China.
The primary endpoints are investigator-assessed progression-free survival (PFS) and overall survival (OS).
Secondary outcome measures include objective response rate (ORR), complete response rate (CRR), duration of response (DoR), and safety and pharmacokinetics (PK) profiles.
HMPL-760 is a highly potent and selective third-generation BTK inhibitor designed to overcome resistance seen with earlier-generation covalent inhibitors, specifically those harboring the C481S mutation.
DLBCL is the most common form of aggressive non-Hodgkin lymphoma in China, and the current standard of care for patients who are ineligible for stem cell transplantation remains a significant unmet medical need.
The initiation of this Phase III trial follows encouraging results from earlier Phase II testing, which demonstrated manageable safety and preliminary clinical benefit.