- In previously untreated nongerminal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), the addition of ibrutinib to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) delivered numerical but not statistically significant improvements in survival outcomes among younger patients.
Why this matters
- No novel therapy has succeeded in outperforming R-CHOP in this setting in the last 2 decades.
- Phase 3 study to investigate ibrutinib combined with R-CHOP in 838 patients with previously untreated non-GCB DLBCL.
- 419 patients received ibrutinib+R-CHOP; 419 received placebo+R-CHOP.
- Median patient age: 62.0 years.
- Funding: Janssen Global Services; Memorial Sloan Kettering Cancer Center.
- The addition of ibrutinib delivered no significant improvement in:
- Event-free survival (EFS) in the intent-to-treat population (ITT; P=.5906).
- EFS in patients with ABC subtype disease (P=.7311).
- PFS (P=.5027).
- OS (P=.9593).
- In a post hoc analysis of patients aged
- EFS: HR, 0.579; 95% CI, 0.380-0.881.
- PFS: HR, 0.556; 95% CI, 0.359-0.860.
- OS: HR, 0.330; 95% CI, 0.162-0.673.
- Enrollment bias toward fit study population.