Hutchmed Launches Phase III DLBCL Trial of HMPL-760 in 240 Patients
Hutchmed has dosed the first patient in its registrational Phase III trial of HMPL-760 plus R-GemOx for relapsed/refractory diffuse large B-cell lymphoma in China on March 20, 2026, targeting progression-free and overall survival in approximately 240 patients. The randomized, double-blind study will compare HMPL-760 against placebo in patients ineligible for transplantation.
1. Phase III Trial Launch
Hutchmed initiated its registrational Phase III trial of HMPL-760 in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory diffuse large B-cell lymphoma in China, dosing the first patient on March 20, 2026.
2. Study Design and Endpoints
This randomized, double-blind study will enroll approximately 240 patients ineligible for transplantation, comparing HMPL-760 plus R-GemOx versus placebo plus R-GemOx, with primary endpoints of progression-free survival and overall survival and key secondary measures including objective response rate, complete response rate and safety.
3. HMPL-760 Profile and Clinical Rationale
HMPL-760 is a non-covalent, third-generation BTK inhibitor that potently and reversibly targets both wild-type and C481S-mutated BTK; prior Phase II data showed improvements in ORR, CRR, PFS and OS with a manageable safety profile, supporting this registrational study.