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.
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
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.