What the study found
Tucidinostat plus R-CHOP led to better event-free survival than R-CHOP alone in newly diagnosed MYC/BCL2 double-expressor diffuse large B-cell lymphoma, a type of diffuse large B-cell lymphoma defined by coexpression of MYC and BCL2 proteins. The treatment also produced a higher complete response rate, and the added toxicity was described as manageable.
Why the authors say this matters
The authors conclude that this offers a new first-line therapeutic approach for this high-risk population. They also say the trial is the first to show benefit from an epigenetic modulator, a drug that affects how genes are turned on or off, in diffuse large B-cell lymphoma.
What the researchers tested
This was a randomized, double-blind, placebo-controlled phase 3 trial at 40 centers in China. A total of 423 eligible patients were assigned to receive oral tucidinostat or matching placebo plus six cycles of R-CHOP, and patients with a complete response could then receive maintenance tucidinostat or placebo for up to 24 weeks.
What worked and what didn't
The tucidinostat group had a lower risk of disease progression, relapse after complete response, death, or starting new therapy for residual disease than the placebo group (hazard ratio, 0.72). The 2-year event-free survival rate was 60.3% with tucidinostat versus 50.5% with placebo, and complete response rates were 73.0% versus 61.8%, respectively. The abstract does not report any benefit for overall survival.
What to keep in mind
The abstract reports increased toxicity with tucidinostat, though it was generally manageable with supportive care. The summary provided does not describe detailed limitations beyond the study setting, and the follow-up reported here was a median of 41.3 months.
- Tucidinostat plus R-CHOP improved event-free survival compared with R-CHOP alone.
- The 2-year event-free survival rate was 60.3% with tucidinostat and 50.5% with placebo.
- Complete response occurred in 73.0% of patients in the tucidinostat group and 61.8% in the placebo group.
- The trial enrolled 423 patients at 40 centers in China and used a randomized, double-blind, placebo-controlled phase 3 design.
- Toxicity was higher with tucidinostat but was generally manageable with supportive care.

