5-year update of the pivotal trial with brentuximab vedotin

This article was written by Robert Chen from the City of Hope National Medical Center, Duarte, CA, et al., and published in Blood in September 2016. They presented the 5-year update of the pivotal trial with brentuximab vedotin, in 102 Relapsed/Refractory (R/R) Hodgkin lymphoma (HL) patients who received single-agent brentuximab vedotin (BV) in an outpatient setting after failure of  hematopoietic autologous stem cell transplantation.

The highlights of the article are as follows:

• 5-year Overall Survival (OS) rate = 41%
• 5-year Progression-Free Survival (PFS) rate = 22%
• Complete response (CR) rate = 33% (34/102)
• For patients in CR, the OS rate was 64% and the PFS rate 52%
• Peripheral neuropathy (PN): 55% (56/102) with resolution or improvement of symptoms within 1 week to > 1 year
• Key point to note: Long responses (> 5 years) achieved for 38% of patients (13 of 34) in CR, without any additional therapy (9/13 without any allogeneic transplantation.

Conclusions:

This 5-year update confirmed the ability of brentuximab vedotin to induce long-term remission in R/R HL patients.

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

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. At 5 years, the overall patient population (N = 102) had an estimated overall survival (OS) rate of 41% (95% confidence interval [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 stem cell transplant, and 9 (9% of all enrolled patients) remain in sustained CR without receiving any further anticancer therapy after treatment with brentuximab vedotin. Of the patients who experienced treatment-emergent peripheral neuropathy, 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 achieved long-term disease control and may potentially be cured. The trial was registered at www.clinicaltrials.gov as #NCT00848926.