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Ibrutinib plus nivolumab for relapsed/refractory CNS lymphoma: Phase II results
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Patients with CNS lymphoma have a poor prognosis and limited treatment options, particularly in the relapsed setting.1 Previous studies suggest that ibrutinib may be effective in this setting, with potential synergy when combined with nivolumab.1 Chihara et al.1 conducted a phase II, open-label, single-arm trial evaluating ibrutinib and nivolumab in patients with R/R CNS lymphoma (NCT03770416) (N = 18). Cohort A (n = 10) received ibrutinib (560 mg QD) as a sole agent for the first 28-day cycle before adding nivolumab (240 mg IV Q2W), while Cohort B (n = 8) received both drugs from Cycle 1.1 The primary objective was to determine the best ORR.1 Secondary objectives included the ORR of ibrutinib monotherapy as a lead-in prior to combination therapy in Cohort A, best CR rate for the combination, 1-year PFS and OS, and safety of the combination. Findings were published in Blood Advances.1 |
| Key learnings |
| The ORR was 77.8% among all patients, with 50% of patients achieving a CR. The median PFS was 6.5 months, with a median OS of 21 months. |
| Response rates were numerically higher in Cohort A, with an ORR of 90% and CR rate of 60% compared to a 62.5% ORR and a 12.5% CR rate in Cohort B. |
| Treatment was generally well tolerated, with fatigue and nausea being the most common AEs. Grade 3/4 AEs were observed in 50% of patients, with no fatal (Grade 5) AEs. Two patients discontinued therapy due to toxicity. |
| These findings highlight the synergistic effect of ibrutinib and nivolumab, particularly when ibrutinib is initiated first. While the small sample size and early closure of the study due to slow enrollment limit its findings, they support further evaluation of targeted therapies beyond conventional chemotherapy for the treatment of R/R CNS lymphoma. |
Abbreviations: AE, adverse event; CNS, central nervous system; CR, complete remission; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QD, once daily; Q2W, every 14 days; R/R, relapsed or refractory.
- Chihara D, Steiner R, Nair R, et al. Phase II trial of ibrutinib and nivolumab in patients with relapsed CNS lymphomas. Blood Advances. 2025. DOI: 10.1182/bloodadvances.2024014635. Online ahead of print.
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