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Adcetris® (brentuximab vedotin) approved by Health Canada as post-ASCT consolidation treatment of Hodgkin Lymphoma (HL)

Jul 27, 2017

On 25 thJuly 2017, Health Canadagranted a non-conditional marketing authorization to Adcetris®(Brentuximab Vedotin; BV), an antibody-drug conjugate directed against CD30, as consolidation post-Autologous Stem Cell Transplant (ASCT) for patients with Hodgkin Lymphoma (HL) at increased risk of relapse or progression. 1 

This decision was made based on results from the randomized phase III AETHERA trial ( NCT01100502), which aimed to assess the efficacy and safety of BV and best supportive care versusplacebo and best supportive care in patients with high risk of residual HL after ASCT. In 2015, Prof. Craig Moskowitzfrom the Memorial Sloan Kettering Cancer Center, New York, NY, USA, et al. publishedfindings from the trial in the Lancet: 2

Key Highlights:

  • Patients enrolled = 329 patients; patients were randomly assigned to BV (n=165) or the placebo (n=164)
  • PFS by independent review was significantly improved with BV versusplacebo (HR, 0.57; 95% CI, 0.40–0.81; P= 0.0013)
  • Median PFS by independent review for BV patients was 42.9 months (95% CI, 30.4–42.9) versus1 months (95% CI, 11.5–not estimable) for placebo patients
  • Consistent benefit (HR <1) of BV consolidation observed across subgroups
  • The most frequent AEs with BV and placebo were peripheral sensory neuropathy (94/167 [56%] vs25/160 [16%]) and neutropenia (35% vs 12%)
  • At time of analysis, 28/167 (17%) patients had died in the BV arm versus25/160 (16%) in the placebo arm

Previously in 2013, Adcetris® was granted conditional marketing authorization by Health Canada for two lymphoma indications: HL patients who relapse after ASCT or in patients ineligible for ASCT who experience relapse after ≥2 multi-agent chemotherapy regimens; and for systemic Anaplastic Large Cell Lymphoma (sALCL) patients who relapse after ≥1 multi-agent chemotherapy regimen. 1

Currently, BV is being evaluated in a number of phase III clinical trials including the ECHELON-1 ( NCT01712490) and ECHELON-2 ( NCT01777152) trials in frontline classical HL and frontline mature T-Cell Lymphomas, respectively, as well as the recently initiated CheckMate 812 trial of BV plus nivolumab in relapsed/refractory HL ( NCT03138499).

Furthermore, the randomized, open-label, phase III ALCANZA trial ( NCT01578499) of BV compared to investigator’s choice (methotrexate or bexarotene) in patients with CD30+ Cutaneous T-Cell Lymphoma was recently completed – read more hereor watch our interviewwith Prof. Miles Princefrom the Peter MacCallum Cancer Center, Melbourne, AUS, on the trial’s final results at ICML2017.

  1. Street Insider. Seattle Genetics (SGEN) Granted Approval of ADCETRIS (Brentuximab Vedotin). 2017 Jul 25. https://www.streetinsider.com/Corporate+News/Seattle+Genetics+%28SGEN%29+Granted+Approval+of+ADCETRIS+%28Brentuximab+Vedotin%29/13125348.html. [Accessed 2017 Jul 26].
  2. Moskowitz C.H. et al.Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. DOI: 10.1016/S0140-6736(15)60165-9.[Epub 2015 Mar 19].