Tucidinostat Plus R-CHOP Improves Event-Free Survival in DEL DLBCL
Key Takeaways
- Event-free survival was better with tucidinostat plus R-CHOP than with placebo plus R-CHOP.
- Complete response was observed more often with the tucidinostat-containing regimen.
- Toxicity was higher with tucidinostat and was generally manageable with supportive care.
This randomized, double-blind, placebo-controlled phase 3 trial was conducted at 40 study centers in China and enrolled 423 eligible patients randomized 1:1. Enrollment ran from May 21, 2020, through July 25, 2022, in patients with newly diagnosed MYC/BCL2 double-expressor diffuse large B-cell lymphoma. Participants received oral tucidinostat 20 mg on days 1, 4, 8, and 11 of each 21-day cycle plus 6 cycles of R-CHOP, or matching placebo plus 6 cycles of R-CHOP. Patients with complete response after combination therapy could continue assigned maintenance for up to 24 weeks. The median age was 63 years, and 47.5% were male. Event-free survival was the primary end point.
Follow-up extended through June 26, 2025, with a median follow-up from randomization of 41.3 months. The event-free survival hazard ratio was 0.72 for tucidinostat plus R-CHOP versus placebo plus R-CHOP (95% CI, 0.54 to 0.96; P value = .02). At that follow-up, event-free survival remained in favor of tucidinostat.
Complete response was observed in 73.0% of patients receiving tucidinostat plus R-CHOP and 61.8% receiving placebo plus R-CHOP, an absolute difference of 11.1% (95% CI, 2.3% to 20.0%). Secondary end points included progression-free survival, disease-free survival, overall survival, and tolerability. Toxicity was higher in the tucidinostat group and was generally manageable with supportive care.