Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. The approval is based on data from the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, which demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) in patients randomized to KEYTRUDA® in combination with CRT compared with patients randomized to placebo plus CRT.
"The approval of KN-A18 is an important addition to the treatment of gynecological cancers, as it has demonstrated a statistically significant improvement in overall survival and progression-free survival in patients with FIGO 2014 Stage III-IVa," stated Shannon Salvador, Gynecologic Oncologist at the Jewish General Hospital and President of the Society of Gynecologic Oncology of Canada. "This recent approval adds another therapeutic option for patients in an important disease space."
"This approval marks a pivotal moment for patients, as it represents the first indication in Canada for KEYTRUDA® in combination with chemoradiotherapy," said André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "Reaffirming our commitment to cervical cancer, we are eager to continue expanding treatment options for patients impacted by this disease."
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