HUTCHMED Initiates Phase III Trial of HMPL-760 in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma in China

The trial will evaluate the efficacy, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus placebo in DLBCL patients.

Mar. 23, 2026 at 12:34am

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HUTCHMED (China) Limited has initiated a registrational Phase III clinical trial of HMPL-760 in combination with R-GemOx (rituximab, gemcitabine and oxaliplatin) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in China. The trial aims to evaluate the efficacy, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus placebo in DLBCL patients who are relapsed or refractory after prior treatment and ineligible for transplantation.

Why it matters

DLBCL is the most common form of aggressive non-Hodgkin lymphoma worldwide, accounting for approximately 40% of all NHL cases in China. With around 81,000 new cases of NHL estimated to have been diagnosed in China in 2022, the development of new treatment options for DLBCL is crucial. HMPL-760 is a highly potent, selective, and reversible inhibitor of Bruton's tyrosine kinase (BTK), a validated target for drugs aimed at treating certain hematological cancers.

The details

The Phase III trial is a randomized, double-blind, positive controlled study to evaluate the efficacy, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in DLBCL patients who are relapsed or refractory after prior treatment. The primary outcome measures include investigator-assessed progression-free survival and overall survival, while secondary measures include independent review committee-assessed progression-free survival, objective response rate, complete response rate, duration of response, clinical benefit rate, time to response, safety, and pharmacokinetic characteristics.

  • The first patient received the first dose on March 20, 2026.
  • The trial plans to enroll approximately 240 patients.

The players

HUTCHMED (China) Limited

A commercial-stage, biopharmaceutical company committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases.

HMPL-760

An investigational, non-covalent, third generation Bruton's tyrosine kinase (BTK) inhibitor that is a highly potent, selective, and reversible inhibitor with long target engagement against BTK, including wild-type and C481S-mutated BTK.

Professor Weili Zhao

The principal investigator of the trial, who is the Vice President of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Director of the Shanghai Institute of Hematology.

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What they’re saying

“This registrational trial plans to enroll approximately 240 patients and is being led by principal investigator Professor Weili Zhao, Vice President of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Director of the Shanghai Institute of Hematology.”

— HUTCHMED

What’s next

Additional details about the trial may be found at clinicaltrials.gov, using identifier NCT07409428.

The takeaway

The initiation of this Phase III trial for HMPL-760 in relapsed/refractory DLBCL patients represents an important step in the development of a potential new treatment option for this aggressive form of non-Hodgkin lymphoma, which is a significant unmet medical need in China.