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®.
The World Cancer Declaration recognises that to make major reductions in premature deaths, innovative education and training opportunities for healthcare workers in all disciplines of cancer control need to improve significantly.
ecancer plays a critical part in improving access to education for medical professionals.
Every day we help doctors, nurses, patients and their advocates to further their knowledge and improve the quality of care. Please make a donation to support our ongoing work.
Thank you for your support.