Induction triplet therapy with rituximab, ibrutinib, and lenalidomide may be an effective therapeutic option for patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), according to a study published in The Lancet Haematology.1
Previous studies demonstrated that monotherapy with ibrutinib and combination therapy with lenalidomide plus rituximab have high activity in MCL.
For the open-label phase 2 PHILEMON study (ClinicalTrials.gov Identifier: NCT02460276), researchers assigned 50 patients with R/R MCL to receive induction therapy with intravenous or subcutaneous rituximab, oral ibrutinib, and oral lenalidomide for up to 12 cycles. Eligible patients were previously treated with at least 1 rituximab-based regimen. Patients who had a complete remission, partial response, or stable disease entered a maintenance phase on ibrutinib and rituximab only.
After a median follow-up of 17.8 months, 76% (38) of patients had an overall response (95% CI, 63%-86%), of which 56% (28) had a complete response (95% CI, 42%-69%) and 20% (10) had a partial response (95% CI, 11%-33%).
The most frequently reported grade 3 to 4 adverse events included neutropenia, infection, and cutaneous toxicity. Three treatment-related deaths (2 from sepsis and 1 from embolic stroke) were noted.
The authors concluded that “the triplet combination of ibrutinib, lenalidomide, and rituximab is an active regimen in patients with relapsed or refractory mantle cell lymphoma, and should be evaluated in a prospective randomised controlled trial.”
- Jerkeman M, Eskelund CW, Hutchings M, et al. Ibrutinib, lenalidomide, and rituximab in relapsed or refractory mantle cell lymphoma (PHILEMON): a multicentre, open-label, single-arm, phase 2 trial. Lancet Haematol. 2018 Jan 29. doi: 10.1016/S2352-3026(18)30018-8 [Epub ahead of print]