The European Commission has approved the immune checkpoint inhibitor Keytruda (pembrolizumab) to treat certain Hodgkin lymphoma patients in 31 European countries, Merck announced.
The approval applies to patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who either failed autologous stem cell transplant (ASCT) and Adcetris (brentuximab vedotin), or who are ineligible for ASCT and didn’t respond to Adcetris.
The approval follows a positive opinion in March by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
“For patients with classical Hodgkin lymphoma who have not been successfully treated with prior therapies – many of whom are young and have a poor prognosis – there are limited options and treating the disease poses significant challenges,” Dr. Pier Luigi Zinzani, an associate professor of hematology at Italy’s University of Bologna, said in a press release. “With this approval, we will now be able to provide these patients with a much-needed new treatment option.”
The EC’s approval was based on data from the KEYNOTE-087 Phase 2 trial (NCT02453594) and the KEYNOTE-013 Phase 1b trial (NCT01953692). The two multicenter, open-label studies assessed Keytruda’s safety and efficacy in 241 cHL patients who failed ASCT and Adcetris, who were ineligible for ASCT — because they did not achieve a complete or partial response following salvage chemotherapy — and failed Adcetris, or who failed ASCT and did not receive Adcetris.
KEYNOTE-087 enrolled 210 patients who received 200 mg Keytruda every three weeks until unacceptable toxicity or disease progression. Among the participants, 81 percent were refractory to at least one prior therapy, 61 percent had undergone ASCT, and 17 percent had not received Adcetris.
After a median follow-up of 10.1 months, the overall response rate was 69 percent, including 22 percent with complete responses and 47 percent with partial responses; 76 percent of patients responded to the treatment for six months or longer, and the median duration of response was 11.1 months.
In the KEYNOTE-013 trial, 31 patients received Keytruda every two weeks at a dose of 10 mg/kg. Among the participants, 87 percent were refractory to at least one prior therapy, 74 percent had undergone ASCT, and 42 percent had received prior radiation therapy. Following a median follow-up time of 28.7 months, 18 patients (58 percent) responded to the treatment, including 19 percent with complete responses and 39 percent with partial responses. Median duration of response was not reached.
Keytruda will now be marketed in all 28 EU member states, plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until unacceptable toxicity or signs of disease progression.
“Today’s approval brings an important new treatment option to patients in Europe with classical Hodgkin lymphoma who have not responded to existing therapies,” said Dr. Roger Dansey, a top official at Merck Research Laboratories. “This milestone underscores our commitment to evaluating Keytruda in diseases with unmet need facing the hematology community.”
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