EMA’s CHMP Recommends Approval of Merck’s KEYTRUDA® for the Treatment of Patients with Relapsed or R

Merck has announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA^® (pembrolizumab), the company’s anti-PD-1 therapy, 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 recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A decision on approval is expected in the second quarter of 2017.

"This CHMP positive recommendation brings us one step closer to offering appropriate patients in the European Union with classical Hodgkin lymphoma a new treatment option to help fight this hematologic cancer," said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. "Today’s news reflects Merck’s ongoing commitment to bring forward new options for patients with a wide range of cancers."

The positive opinion was based on data from the KEYNOTE-087 and KEYNOTE-013 trials. These multicenter, open label trials 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.

Both studies included patients regardless of PD-L1 expression. The major efficacy outcome measures, overall response rate and complete remission rate, were assessed by blinded independent central review according to the 2007 revised International Working Group (IWG) criteria. Secondary efficacy outcome measures were duration of response, progression-free survival and overall survival.