R/R DLBCL: ibrutinib, lenalidomide, rituximab regimen promising in non-GCB disease

  • Goy A & al.
  • Blood
  • 22 Jul 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • Lenalidomide maximum tolerated dose (MTD) was not reached.
  • Responses:
    • 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%.

Limitations

  • Phase 1b, single-group study.