The Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab; Merck) as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL), and for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Previously, the treatment had been granted accelerated approval for adults and children with refractory CHL, or who have relapsed after 3 or more prior lines of therapy based on data from the KEYNOTE-087 trial.

The expanded approval was based on data from the randomized, open-label, phase 3 KEYNOTE-204 trial that evaluated the efficacy and safety of pembrolizumab, a human programmed death receptor-1 (PD-1)-blocking antibody, in 304 adults with relapsed or refractory cHL after at least 1 multi-agent chemotherapy regimen. Patients were randomized to receive either pembrolizumab 200mg (n=151) or brentuximab vedotin (BV) 1.8mg/kg (n=153) intravenously every 3 weeks for up to 35 cycles. The primary end point of the study was progression-free survival (PFS).

Results showed that pembrolizumab significantly reduced the risk of disease progression or death by 35% (hazard ratio [HR] 0.65; 95% CI, 0.48-0.88; P <.0027) compared with BV; median PFS was 13.2 months (95% CI, 10.9-19.4) in the pembrolizumab arm vs 8.3 months (95% CI, 5.7-8.8) with BV.

Among patients treated with pembrolizumab, the objective response rate (ORR) was 66% (95% CI, 57-73), with a complete response rate of 25% and a partial response rate of 41%. In the BV arm, the ORR was 54% (95% CI, 46-62), with a complete response rate of 24% and a partial response rate of 30%; the difference in ORR was not found to be statistically significant. Duration of response among patient responders was observed to be 20.7 months (range: 0.0+ to 33.2+) with pembrolizumab and 13.8 months (range: 0.0+ to 33.9+) with BV.

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  1. FDA approves expanded Indication for Merck’s Keytruda® (pembrolizumab) in adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). [press release]. Kenilworth, NJ: Merck; October 15, 2020. 
  2. Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co., Inc; 2020.