Posted by Michael Wonder on 12 Dec 2017
FDA accepts supplemental biologics license application, assigns priority review to Merck’s Keytruda (pembrolizumab) for treatment of relapsed or refractory primary mediastinal large B-cell lymphoma
11 December 2017 - Data for Keytruda in patients with relapsed or refractory PMBCL show overall response rate of 41% in difficult-to-treat patient population.
Merck today announced findings from the phase 2 KEYNOTE-170 trial investigating the use of Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in the cohort of patients with relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma. In the PMBCL cohort of KEYNOTE-170, Keytruda demonstrated an overall response rate (ORR) of 41% (n=12/29), including a 24% (n=7/29) complete response rate and a 17% (n=5/29) partial response rate, in patients who relapsed after or were refractory to autologous stem cell transplant (ASCT), or were ineligible for ASCT and failed two or more prior lines of therapy.
Based on data from KEYNOTE-170 and the phase 1b KEYNOTE-013 trial, which is evaluating the safety, tolerability and efficacy of Keytruda monotherapy in patients with various blood cancers, the U.S. FDA has accepted for review a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for the treatment of adult and paediatric patients with refractory primary mediastinal B-cell lymphoma, or who have relapsed after two or more prior lines of therapy. The FDA granted priority review status with a PDUFA, or target action, date of 3 April 2018. In January 2017, Keytruda was granted breakthrough therapy designation by the FDA for this indication.
