Merck's Keytruda receives FDA approval to treat patients with refractory classical Hodgkin lymphoma

Only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat cHL regardless of prior stem cell transplantation or use of brentuximab vedotin

Under the FDA’s accelerated approval regulations, this indication is approved based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In refractory or relapsed cHL, Keytruda is approved for use in adult patients at a fixed dose of 200 mg and in pediatric patients at a dose of 2 mg/kg (up to a maximum of 200 mg). Keytruda is administered intravenously every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

The approval is based on data in 210 patients from the KEYNOTE-087 trial, which demonstrated an overall response rate (ORR) with Keytruda (200 mg every 3 weeks) of 69% with a complete remission rate (CRR) of 22% and a partial remission rate (PRR) of 47%. The median follow-up time was 9.4 months. Among the 145 responding patients, the median duration of response was 11.1 months.

“The results from KEYNOTE-087 showed that most patients with relapsed or refractory classical Hodgkin lymphoma responded to treatment with Keytruda, and 22% experienced complete remission,” said Dr Roger M. Perlmutter, president, Merck Research Laboratories. “Today’s approval – the first for Keytruda in a hematologic malignancy – reinforces the hope that immunotherapy will prove useful in a wide variety of cancers.”

“For the patients with classical Hodgkin lymphoma who are not cured with existing treatments, there are limited options, and treating their disease becomes more challenging,” said Dr Craig Moskowitz, clinical director, division of hematologic oncology, Memorial Sloan Kettering Cancer Center. “This approval is an important step forward in treating these patients, who are generally young and have a particularly poor prognosis, and gives us the opportunity to help patients in their fight against this devastating disease.”