Treatment of relapsed or refractory classical Hodgkin lymphoma (cHL) patients in Europe with Merck’s Keytruda (pembrolizumab) became more likely, with the issuance of a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
The European Commission will now review Keytruda’s use in the 28-member European Union and will reach a decision by June 30.
“Today’s news reflects Merck’s ongoing commitment to bring forward new options for patients with a wide range of cancers,” Roger Dansey, MD, senior vice-president and therapeutic area head for oncology late-stage development at Merck Research Laboratories said in a press release.
The CHMP based its positive opinion 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 the safety and efficacy of Keytruda (200 mg dose, every three weeks) in patients with refractory classical Hodgkin lymphoma or who relapsed after at least three prior lines of therapy, regardless of their PD-L1 status.
Study participants had either failed autologous stem cell transplant (ASCT) and Adcetris (brentuximab vedotin), were ineligible for ASCT — because they did not achieve a complete or partial response following salvage chemotherapy — and failed to respond to Adcetris, or failed to respond to ASCT and did not receive Adcetris.
Data from the KEYNOTE-087 study, presented in December at the American Society of Hematology (ASH) 2016 Annual Meeting in Atlanta has shown promising anti-tumor activity in 210 relapsed or refractory cHL patients, with an overall response rates of 69 percent, and with 22 percent of patients achieving a complete response. Overall, 92 percent of patients experienced a decrease in tumor burden.
Likewise, the KEYNOTE-013 study, which enrolled 31 patients with relapsed or refractory cHL, showed an overall response rate of 66 percent, with 21 percent complete responses; 86 percent of patients saw clinical improvements.
Based on those findings, the U.S. Food and Drug Administration approved Keytruda for classical Hodgkin lymphoma patients who relapsed after three or more prior lines of therapy — marking the first time the drug has been approved to treat a hematological cancer.