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 1:39am

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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 NHL cases estimated in China in 2022, this trial represents an important step in developing a potential new treatment option for DLBCL patients who have limited options after relapsing or becoming refractory to prior therapies.

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. 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

An innovative, 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 for 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

The takeaway

This Phase III trial of HMPL-760 in combination with R-GemOx represents an important step in developing a potential new treatment option for DLBCL patients in China who have limited options after relapsing or becoming refractory to prior therapies. The trial's focus on evaluating the efficacy, safety, and pharmacokinetics of this novel BTK inhibitor could lead to a new therapeutic approach for this aggressive form of non-Hodgkin lymphoma.