On October 14, 2020, the FDA expanded the approval of pembrolizumab to include adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and pediatric patients with refractory cHL or cHL that has relapsed after 2 or more lines of therapy.
This approval was based on the phase 3 KEYNOTE-204 trial, which randomized 304 adult patients in a 1:1 ratio to receive either pembrolizumab 200 mg every 3 weeks or brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks for up to 2 years.
Efficacy was based on progression-free survival (PFS) per blinded independent central review assessment.
The median PFS was 13.2 months (95% CI: 10.9, 19.4) in the pembrolizumab arm compared with 8.3 months (95% CI: 5.7, 8.8) in the BV arm, with a hazard ratio of 0.65 (95% CI: 0.48, 0.88; P = .0027).
Serious adverse events (AEs) were reported in 30% of patients receiving pembrolizumab. Serious AEs occurring in ≥1% of patients included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis.
Additional AEs in ≥20% of patients receiving pembrolizumab were upper respiratory tract infection, musculoskeletal pain, diarrhea, cough, pyrexia, fatigue, and rash. Overall, 38% of patients had AEs requiring systemic corticosteroids, including pneumonitis (11%).—Janelle Bradley
