ISHL10 Abstract T022

CheckMate 205 cohort C: Nivolumab in patients with classical Hodgkin Lymphoma after prior Brentuximab Vedotin and autologous hematopoietic stem cell transplantation

Background: Nivolumab (nivo), a fully human IgG4 immune checkpoint inhibitor monoclonal antibody targeting programmed death receptor-1 (PD-1), is approved in the USA for classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (ASCT) and post-transplantation brentuximab vedotin (BV). CheckMate 205 is a multicohort international phase 2 trial (NCT02181738) of nivo that treated 243 pts with cHL after failure of ASCT in 3 cohorts: A (BV-naïve pts), B (pts with BV treatment after ASCT), and C (pts who received BV prior to and/or after ASCT). With a minimum 6-mo follow-up in Cohort B, ORR per independent radiologic review committee (IRRC) was 66% and 6-mo PFS was 77%, with an acceptable safety profile (Younes et al. Lancet Oncol 2016 [in press]) Here we present preliminary results of pts from Cohort C, with a minimum follow-up of 6 mo.

Aim: Assess efficacy and safety of nivo in previously unreported Cohort C pts, including those who received BV prior to ASCT (not tested in Cohort B).

Methods: Pts in Cohort C received nivo 3 mg/kg IV q2 wk until disease progression, unacceptable toxicity, or investigator-assessed complete response (CR) lasting 1 yr. Pts who discontinued nivo with CR could re-initiate nivo if they relapsed ≤2 yr from discontinuation. The primary endpoint was ORR per IRRC using 2007 International Working Group criteria, based on CT and PET imaging. Pts were divided into subgroups by timing of prior BV treatment relative to ASCT.

Results: 100 pts were treated, with a median age of 32 (range 19–69), and a median of 4 (range 2–9) prior lines of therapy. ORR by IRRC after a median follow-up of 8.8 mo was 73% overall, and >69% in all BV subgroups (Table). 6-mo PFS was 77% overall, and >71% in all subgroups (Table). Median time to response in the entire cohort was 2.1 mo (range 0.8–6.5), and median duration of response was 7.0 mo (95% CI 6.7, NA). 6-mo OS was 93.9% (95% CI 86.9%, 97.2%). 68% of pts had drug-related AEs between first dose and 30 days after last dose of nivo, most commonly fatigue, diarrhea, and infusion reactions (11% each). 19% had G3-4 drug-related AEs. At present, no pt has discontinued study therapy due to persistent CR lasting 1 yr.

Conclusion: Nivo had clinically meaningful antitumor activity and acceptable safety in heavily pretreated cHL pts, regardless of the timing of prior BV relative to failure of ASCT.

Funding: BMS. Medical writing: Caudex, funded by BMS.

Authors

  • P.L. Zinzani
  • A. Engert
  • A. Younes
  • A. Santoro
  • S. Ansell
  • J. Timmerman
  • G.P. Collins
  • P. Armand
  • K.J. Savage
  • M. Trneny
  • M. Fanale
  • J. Kuruvilla
  • J.B. Cohen
  • M. Shipp
  • S. Rodig
  • K. Kato
  • A. Sumbul
  • B.A. Farsaci
  • V. Ratanatharathorn

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