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Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma

Robert Chen, Ajay K. Gopal, Scott E. Smith, Stephen M. Ansell, Joseph D. Rosenblatt, Kerry J. Savage, Joseph M. Connors, Andreas Engert, Emily K. Larsen, Dirk Huebner, Abraham Fong and Anas Younes

Key points

  • A total of 38% of patients who achieved CR (13 of 34) on brentuximab vedotin have remained in remission for over 5 years and may be cured.

  • Nine of the 13 patients (9% of all enrolled patients) have remained in long-term remission without a consolidative allogeneic transplant.

Abstract

Presented here are the 5-year, end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation (auto-SCT). At 5 years, the overall patient population (N=102) had an estimated overall survival (OS) rate of 41% (95% CI: 31, 51) and progression-free survival (PFS) rate of 22% (95% CI: 13, 31). Patients who achieved a complete response (CR) to brentuximab vedotin (N=34) had estimated OS and PFS rates of 64% (95% CI: 48%, 80%) and 52% (95% CI: 34%, 69%), respectively. The median OS and PFS were not reached in CR patients, with 13 patients (38% of all CR patients) remaining in follow-up and in remission at study closure. Of the 13 patients, 4 received consolidative hematopoietic allogeneic-SCT (allo-SCT), and 9 (9% of all enrolled patients) remain in sustained CR without receiving any further anti-cancer therapy after treatment with brentuximab vedotin. Of the patients who experienced treatment-emergent peripheral neuropathy (PN), 88% experienced either resolution (73%) or improvement (14%) in symptoms. These 5-year follow-up data demonstrate that a subset of patients with R/R HL who obtained CR with single-agent brentuximab vedotin have achieved long-term disease control and may potentially be cured. The trial was registered at www.clinicaltrials.gov as #NCT00848926.

  • Submitted February 17, 2016.
  • Accepted June 8, 2016.