Pembrolizumab improves PFS for relapsed/refractory Hodgkin lymphoma

Pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with brentuximab vedotin in adult patients with relapsed/refractory classic Hodgkin lymphoma (R/R cHL), meeting one of the dual primary endpoints.

Prof. Pier Luigi Zinzani (University of Bologna, Italy) presented the results of the randomised phase 3 KEYNOTE-204 study, which compared the efficacy and safety of pembrolizumab with that of brentuximab vedotin in patients with R/R cHL [1].

Patients (n=304) were randomly assigned 1:1 to receive intravenous pembrolizumab at 200 mg every 3 weeks for up to 35 cycles or brentuximab vedotin at 1.8 mg/kg every 3 weeks for up to 35 cycles. Patients included had had prior autologous stem-cell transplantation (SCT) or were ineligible for autologous SCT, had measurable disease, and Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. The dual primary endpoints were PFS and overall survival (OS).

The findings presented by Prof. Zinzani were part of the interim analysis that was conducted by an independent data-monitoring committee. According to the prespecified analysis plan, OS was not tested at this time, and the study will continue to evaluate for OS. However, pembrolizumab monotherapy showed statistically significant and clinically meaningful improvement in PFS compared with brentuximab vedotin (13.2 vs 8.3 months; HR 0.65; 95% CI 0.48- 0.88; P=0.00271). In addition, the PFS benefit extended to key pre-specified subgroups of patients with R/R cHL, including those with primary refractory disease or those who did not receive prior autologous SCT. The safety profile was consistent with the known profiles of each agent. OS data is still expected.

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   1. Zinzani PL, et al. Phase 3, Randomized, Open-Label Study of Pembrolizumab Versus Brentuximab Vedotin for Treatment of Relapsed or Refractory Classical Hodgkin Lymphoma: KEYNOTE-204. EHA25 Virtual, 11-21 June 2020, Abstract LB2600.

Posted on 9 September 202018 March 2024