On October 14, 2020, the Food and Drug Administration extended the approval of pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme Corp.) for the following indications: 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.
Approval was based on KEYNOTE-204 (NCT02684292), a phase 3, randomised, open-label trial in 304 adult patients with relapsed or refractory cHL after at least one multiagent regimen.
Patients were randomised (1:1) 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.
PFS was statistically significantly longer in the pembrolizumab arm.
The median PFS was 13.2 months (95% CI: 10.9, 19.4) in the pembrolizumab arm and 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=0.0027).
Serious adverse reactions occurred in 30% of the patients who received pembrolizumab.
Serious adverse reactions in ≥1% of patients included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis.
Adverse reactions in ≥20% of pembrolizumab recipients included upper respiratory tract infection, musculoskeletal pain, diarrhea, cough, pyrexia, fatigue, and rash.
Thirty-eight percent of patients had adverse reactions requiring systemic corticosteroids, including pneumonitis in 11%.
The recommended pembrolizumab dose for patients with lymphoma is 200 mg every 3 weeks or 400 mg every 6 weeks intravenously for adults, or 2 mg/kg (up to 200 mg) every 3 weeks intravenously for pediatric patients, for up to 2 years.
View full prescribing information for KEYTRUDA®.