Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for the treatment of adults and children with refractory classical Hodgkin lymphoma, or who have relapsed after ≥3 prior lines of therapy. 

The indication was approved based on tumor response rate and durability of response under the FDA’s accelerated approval program. The KEYNOTE-087 trial (n=210) was a multicenter, non-randomized, open-label study that evaluated Keytruda 200mg given every 3 weeks until unacceptable toxicity or documented disease progression for up to 24 months in patients who did not progress. The major efficacy outcome measures were overall response rate (ORR), complete remission rate (CRR), and duration of response.

Data from the efficacy analysis showed an ORR of 69% (95% CI: 62–75) with a CRR of 22% and a partial remission rate (PRR) of 47%. Of the 145 responsive patients, the median duration of response was 11.1 months (range 0.0–11.1). Keytruda was stopped due to adverse events in 5% of patients with classical Hodgkin lymphoma and was interrupted due to adverse events in 26% of patients. 

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Efficacy data for pediatric patients was extrapolated from results in the adult classical Hodgkin lymphoma population. In a study of pediatric patients (n=40) with advanced melanoma, PD-L1–positive advanced, relapsed, or refractory solid tumors or lymphoma, patients received Keytruda for a median of 43 days, with 60% of patients receiving treatment for ≥42 days. The safety profile among pediatric patients was similar to that seen in adults treated with Keytruda.

Keytruda, a human programmed death receptor-1 (PD-1)-blocking antibody, is already indicated for various cancers, including melanoma, lung cancer, and head and neck cancer. Keytruda is available as a 50mg/vial lyophilized powder for IV infusion, and as a 25mg/mL solution for IV infusion.

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