HUTCHMED Initiates Phase III Trial Of HMPL-760 Combination Therapy In Diffuse Large B-Cell Lymphoma

HUTCHMED (China) Limited has initiated a registrational Phase III clinical trial evaluating HMPL-760 in combination with the R-GemOx regimen for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in China. The first participant was dosed on March 20, 2026, marking the formal start of the late-stage study.

DLBCL is the most common aggressive form of non-Hodgkin lymphoma and represents about 40% of all NHL cases in China. With tens of thousands of new lymphoma diagnoses annually, there remains a substantial unmet need for effective therapies, particularly for patients who relapse or fail prior treatment. Bruton’s tyrosine kinase (BTK) is a well-established therapeutic target in hematologic cancers, and HMPL-760 is designed as a potent, selective, and reversible BTK inhibitor with sustained target engagement, including activity against both wild-type and C481S-mutated BTK.

The randomised, double-blind, positive-controlled Phase III study will compare HMPL-760 plus R-GemOx (rituximab, gemcitabine, and oxaliplatin) with placebo plus R-GemOx. Eligible participants include patients whose disease has progressed after first-line chemotherapy, immunotherapy, or immunochemotherapy and who are not candidates for transplantation. The primary endpoints are investigator-assessed progression-free survival and overall survival.

Secondary endpoints include independent review committee-assessed progression-free survival, objective and complete response rates, duration of response, clinical benefit rate, time to response, and safety and pharmacokinetic profiles. The study aims to enroll around 240 patients and is led by principal investigator Weili Zhao of Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine.