Merck has announced that its Phase 3 KEYLYNK-001 trial met its primary endpoint of progression-free survival (PFS) in patients with advanced epithelial ovarian cancer. The study evaluated KEYTRUDA plus chemotherapy followed by maintenance with LYNPARZA, with or without bevacizumab, as a first-line treatment for people with BRCA non-mutated advanced epithelial ovarian cancer.
“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.”
The trial demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy alone. However, the study did not reach its secondary endpoint of overall survival, and the role of KEYTRUDA in the intention-to-treat population remains uncertain. The safety profiles of KEYTRUDA and LYNPARZA were consistent with those observed in previously reported studies.
The trial enrolled 1,367 patients and further results will be presented at an upcoming medical meeting and discussed with regulatory authorities.
LYNPARZA currently has three approved indications in ovarian cancer in the U.S., while KEYTRUDA is not approved to treat ovarian cancer.
