Merck, known as MSD outside the United States and Canada, announced that the FDA has approved KEYTRUDA (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy.
Under the FDA’s accelerated approval regulations, this indication is approved based on tumor 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.
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 three weeks) of 69 percent (95% CI: 62, 75) with a complete remission rate (CRR) of 22 percent and a partial remission rate (PRR) of 47 percent. The median follow-up time was 9.4 months. Among the 145 responding patients, the median duration of response was 11.1 months (range 0.0+ to 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 percent 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.”