- Combination ibrutinib, rituximab, and lenalidomide demonstrated favorable activity with durable response in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), particularly in those with nongerminal center B-cell (non-GCB) disease.
Why this matters
- Prognosis is poor in patients ineligible for stem cell transplantation or who fail induction/salvage therapy.
- Phase 1b study of combination ibrutinib, rituximab, and lenalidomide (10, 15, 20, or 25 mg) in 45 transplant-ineligible adults with R/R DLBCL.
- 84% of patients had received ≥2 prior regimens.
- Funding: Pharmacyclics LLC, an AbbVie Company.
- Lenalidomide maximum tolerated dose (MTD) was not reached.
- In all response-evaluable patients: 44% (95% CI, 28%-60%) objective response rate (ORR).
- In non-GCB DLBCL: 65% ORR; 41% complete response (CR).
- In GCB DLBCL: 29% ORR; 18% CR.
- Duration of response (DOR):
- All responders: 15.9 (range, 0.9-37.2+) months.
- Non-GCB DLBCL: 15.9 (range, 0.9-36.5+) months.
- Median DOR has not been reached in patients who achieved CR.
- Most frequent grade 3-4 treatment-emergent adverse events with ibrutinib or lenalidomide, respectively:
- Neutropenia: 38%, 40%.
- Maculopapular rash: 13%, 13%.
- Thrombocytopenia: 9%, 11%.
- Phase 1b, single-group study.