Pembrolizumab prolonged progression-free survival (PFS) compared with brentuximab vedotin (BV) in patients with classical Hodgkin lymphoma (cHL) who relapsed or were refractory after autologous hematopoietic stem cell transplant (HSCT) or who were ineligible for transplant, according to the results of an interim analysis of the KEYNOTE-204 trial published in The Lancet Oncology.
“These data support pembrolizumab as the preferred treatment option for patients with relapsed or refractory cHL who have relapsed post-autologous HSCT or are ineligible for autologous HSCT,” the authors stated.
The open-label, phase 3 KEYNOTE-204 trial (ClinicalTrials.gov Identifier: NCT02684292) randomly assigned 304 patients with relapsed/refractory cHL to receive pembrolizumab or BV. Patients were either ineligible for or had relapsed after an autologous HSCT. The primary coprimary endpoints were PFS and overall survival.
At baseline, the median age was 36 years and 58% of the total study population were men. More patients in the BV group had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 (65%) compared with 57% in the pembrolizumab group. Nearly all remaining patients had a performance status of 1. There were 37% of patients who had undergone a previous autologous HSCT. The median number of previous lines of treatment was 2 in the pembrolizumab group and 3 in the BV group.
During a median follow-up of 2 years, pembrolizumab significantly prolonged PFS, with a median of 13.2 months compared with 8.3 months with BV (hazard ratio, 0.65; 95% CI, 0.48-0.88; P =.0027).
Pembrolizumab also increased the objective response rate at 65.6% compared with 54.2% with BV. Both resulted in a similar proportion of complete response (25% vs 24%, respectively). The median duration of response was 20.7 and 13.8 months with pembrolizumab and BV, respectively.
Treatment-related adverse events occurred among 74% and 77% of patients in the pembrolizumab and BV arms, respectively. Pneumonitis, neutropenia, decreased neutrophil count, and peripheral neuropathy were the most common grade 3 to 5 TRAEs. There was 1 treatment-related death in the pembrolizumab group.
Disclosures: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Kuruvilla J, Ramchandren R, Santoro A, et al. Pembrolizumab versus brentuximab vedotin in relapsed or refractory classical Hodgkin lymphoma (KEYNOTE-204): an interim analysis of a multicentre, randomised, open-label, phase 3 study. Lancet Oncol. 2021;22(4):512-524. doi:10.1016/S1470-2045(21)00005-X