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Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma

Ann S. LaCasce, R. Gregory Bociek, Ahmed Sawas, Paolo Caimi, Edward Agura, Jeffrey Matous, Stephen M. Ansell, Howland E. Crosswell, Miguel Islas-Ohlmayer, Caroline Behler, Eric Cheung, Andres Forero-Torres, Julie Vose, Owen A. O'Connor, Neil Josephson, Yinghui Wang and Ranjana Advani

Key points

  • The outpatient regimen of BV and bendamustine is highly active as first salvage therapy in relapsed/refractory HL, with manageable toxicity

  • The CR rate of 73.6% exceeded those reported for standard chemotherapy regimens, and post-ASCT outcomes generally appeared excellent

Abstract

Autologous stem cell transplantation (ASCT) is standard of care for patients with Hodgkin lymphoma (HL) who have relapsed/refractory disease after frontline chemotherapy. Achievement of complete remission (CR) with pre-ASCT salvage chemotherapy predicts favorable outcomes post-ASCT. This phase 1/2 study evaluated the combination of brentuximab vedotin (BV) plus bendamustine as a first salvage regimen in relapsed/refractory HL. A total of 55 patients (28 primary refractory and 27 relapsed) were enrolled. Patients received BV (1.8 mg/kg) on day 1 and bendamustine (90 mg/m2) on days 1 and 2 of a 21-day cycle for up to 6 cycles. Patients could undergo ASCT any time after cycle 2. Following ASCT or completion of combination therapy if not proceeding to ASCT, patients could receive BV monotherapy for up to 16 cycles of total therapy. After a median of 2 cycles of combination therapy (range, 1 6), the objective response rate among 53 efficacy-evaluable patients was 92.5%, with 39 patients (73.6%) achieving CR. Forty patients underwent ASCT. Thirty-one patients (25 of whom underwent ASCT) received brentuximab vedotin monotherapy (median 10 cycles; range, 1 14). After a median of 20.9 months of follow-up, the estimated 2-year progression-free survival was 69.8% and 62.6% for patients who received ASCT and all patients, respectively. Thirty one patients (56.4%) experienced infusion-related reactions (IRR), with a majority occurring during cycle 2 of combination therapy. A protocol amendment requiring premedication reduced IRR severity. BV plus bendamustine as first salvage therapy in relapsed/refractory HL is highly active with a manageable toxicity profile. Registered at www.clinicaltrials.gov (#NCT01874054).

  • Submitted November 8, 2017.
  • Accepted April 2, 2018.