Phase 3 KEYLYNK-001 Trial Met Primary Endpoint of Progression-Free Survival in Patients With Advanced Epithelial Ovarian Cancer: Merck

“For people living with ovarian cancer, there remains an unmet need for new treatment options that have the potential to improve outcomes,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “KEYLYNK-001 is the first positive Phase 3 trial for KEYTRUDA plus LYNPARZA, highlighting our commitment to research that may help address the global impact of women’s cancers.”

In the U.S., LYNPARZA has three approved indications in ovarian cancer: for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated (g BRCA m or s BRCA m) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy; in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability; and for the maintenance treatment of adult patients with deleterious or suspected deleterious g BRCA m or s BRCA m recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. For each of these indications, patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

KEYTRUDA is not approved to treat ovarian cancer. See selected KEYTRUDA indications in the U.S. below.