On October 14, the U.S. Food and Drug Administration (FDA) extended the approval of pembrolizumab (Keytruda) for the following indications:
Approval was based on KEYNOTE-204, a phase III, randomized, open-label trial in 304 adult patients with relapsed or refractory classical Hodgkin lymphoma treated with at least one prior multiagent regimen. Patients were randomly assigned 1:1 to receive either pembrolizumab at 200 mg every 3 weeks or brentuximab vedotin at 1.8 mg/kg every 3 weeks for up to 2 years. Efficacy was based on progression-free survival per blinded independent central review assessment.
Progression-free survival was statistically significantly longer in the pembrolizumab arm. The median progression-free survival was 13.2 months (95% confidence interval [CI] = 10.9–19.4) in the pembrolizumab arm and 8.3 months (95% CI = 5.7–8.8) in the brentuximab vedotin arm, with a hazard ratio of 0.65 (95% CI = 0.48–0.88, P = .0027).
Serious adverse reactions occurred in 30% of the patients who received pembrolizumab. Adverse reactions in ≥ 20% of pembrolizumab recipients included upper respiratory tract infection, musculoskeletal pain, diarrhea, cough, pyrexia, fatigue, and rash. Serious adverse reactions in ≥ 1% of patients included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. 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.