Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). The approval is based on data from the pivotal Phase 3 IND.227/KEYNOTE-483 trial, which demonstrated a statistically significant improvement in overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) in patients randomized to KEYTRUDA® in combination with chemotherapy compared with patients randomized to chemotherapy alone. This pivotal trial was led by the Canadian Cancer Trials Group (CCTG) in collaboration with the National Cancer Institute of Naples (NCIN) and the Intergroupe Francophone de Cancérologie Thoracique (IFCT).
"This approval marks the first combination treatment of KEYTRUDA® and chemotherapy in Canada for patients with malignant pleural mesothelioma," says Dr. Quincy Chu, Medical Oncologist at the Cross Cancer Institute and Associate Professor at the University of Alberta. "This combination provides a new therapeutic option for this patient group, which has limited options available and may help improve health outcomes."
"We're pleased to announce this first-line treatment option for adults with advanced or metastatic malignant pleural mesothelioma, a condition that often has a challenging prognosis," says André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "This is an important step for us within the mesothelioma space. It demonstrates the CCTG's leadership in advancing patient care and underscores our commitment to research for patients with difficult-to-treat cancers."
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!