FDA expands Keytruda approval for classical hodgkin lymphoma indication based on results from KEYNOTE 204 trial.- Merck Inc.

The FDA has approved Keytruda (pembrolizumab) 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 III 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.>