EU approves Keytruda (pembrolizumab) in relapsed or refractory classical Hodgkin lymphoma- Merck Inc

Merck Inc announced that the European Commission has approved Keytruda (pembrolizumab) for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. The approval allows marketing of KEYTRUDA in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity.

The approval was based on data in 241 patients from the KEYNOTE-087 and KEYNOTE-013 trials. These multicenter, open-label studies evaluated patients with cHL who failed ASCT and BV, who were ineligible for ASCT because they were unable to achieve a complete or partial remission after salvage chemotherapy and failed BV, or who failed ASCT and did not receive BV. In KEYNOTE-087, eighty-one percent of patients were refractory to at least one prior therapy, including 35 percent who were refractory to first-line therapy. Additionally, 61 percent of patients had undergone prior ASCT, 38 percent were transplant ineligible; 17 percent had no prior BV use and 36 percent of patients had prior radiation therapy. Efficacy analysis showed an ORR of 69 percent with a CRR of 22 percent and a partial remission rate (PRR) of 47 percent. In KEYNOTE-013, eighty-seven percent of patients were refractory to at least one prior therapy, including 39 percent who were refractory to first-line therapy. Seventy-four percent of patients had undergone prior ASCT, 26 percent were transplant ineligible, and 42 percent of patients had prior radiation therapy. Efficacy analysis showed an ORR of 58 percent with a CRR of 19 percent and a PRR of 39 percent.