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Pembrolizumab monotherapy improved progression-free survival (PFS) compared to brentuximab vedotin (BV) in patients with relapsed or refractory classical Hodgkin lymphoma (cHL), according to the results of KEYNOTE-204.
John Kuruvilla, MD, of the Princess Margaret Cancer Centre in Canada, lead author and presenter, outlined these findings during the ASCO20 Virtual Scientific Program.
KEYNOTE-204 (ClinicalTrials.gov Identifier: NCT02684292) is a randomized, open-label, phase 3 study comparing pembrolizumab with BV in adult patients with cHL who relapsed after autologous/allogeneic stem cell transplant (SCT) or were ineligible for SCT.
Patients were randomly assigned (1:1) to receive either pembrolizumab (200 mg IV Q3W) or BV (1.8 mg/kg IV Q3W) for up to 35 cycles. The primary endpoints of the study were PFS per blinded, independent, central review including clinical and imaging data after SCT and overall survival (OS). Secondary endpoints included PFS (-secondary) excluding clinical and imaging data after SCT, overall response rate (ORR), PFS by investigator review, and safety. The study also included duration of response (DOR) as an exploratory endpoint. The presented results were from the second interim analysis of the study.
Of the 304 enrolled patients, 300 were treated (148 pembrolizumab and 152 BV). At the time of database cutoff, the median follow up was 24.7 months (range, 0.6-42.3 months). In total, 256 patients discontinued treatment (74% pembrolizumab and 96% BV), primarily because of disease progression. The median time on treatment was 305.0 days (range, 1-814 days) with pembrolizumab and 146.5 days (range 1-794 days) with BV. The portion of patients completing 2 years of treatment was 16.9% in the pembrolizumab arm and 2.0% in the BV arm.
The study met its primary endpoint. Pembrolizumab showed statistically significant improvement in PFS compared with BV (median, 13.2 vs 8.3 months; hazard ratio [HR], 0.65; 95% CI, 0.48-0.88; P =.00271), and the 1-year PFS rates were 53.9% compared with 35.6%, respectively.
Among the secondary endpoints, PFS-secondary was longer in the pembrolizumab arm vs the BV arm (median 12.6 vs 8.2 months; HR, 0.62; 95% CI, 0.46-0.85). Similarly, PFS per investigator assessment was improved with pembrolizumab vs BV (median, 19.2 vs 8.2 months; HR, 0.49; 95% CI, 0.36-0.67). However, these endpoints were not formally tested for statistical significance.
The ORR was 65.6% for the pembrolizumab group and 54.2% for the BV group (P =.02). The CR rates were similar between the groups (24.5% for pembrolizumab and 24.2% for BV). The median DOR was 20.7 months with pembrolizumab and 13.8 months with BV.
Safety was consistent with the known profiles for each agent. Grade 3 to 5 treatment-related adverse events occurred in 19.6% of patients in the pembrolizumab arm and 25.0% of patients in the BV arm. One treatment-related death occurred with pembrolizumab (pneumonia).
“Pembrolizumab should be considered the preferred treatment option and the new standard of care for the treatment of relapsed or refractory classical Hodgkin’s lymphoma in patients that have relapsed post-autologous stem cell transplant or are ineligible for autologous stem cell transplant,” Dr Kuruvilla concluded.
Kuruvilla J, Ramchandren R, Santoro A, et al. KEYNOTE-204: Randomized, open-label, phase III study of pembrolizumab (pembro) versus brentuximab vedotin (BV) in relapsed or refractory classic Hodgkin lymphoma (R/R cHL). Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 8005.