KEYLYNK-001: Keytruda + chemo, Lynparza for BRCA ovarian cancer.
Merck Inc., ( known as MSD outside of the United States and Canada), announced that the Phase III KEYLYNK-001 trial evaluating Keytruda (pembrolizumab) plus chemotherapy followed by maintenance with Lynparza (olaparib), with or without bevacizumab, as a first-line treatment for people with BRCA non-mutated advanced epithelial ovarian cancer met its primary endpoint of progression-free survival (PFS)
At the final analysis conducted by an independent Data Monitoring Committee, the Keytruda plus Lynparza regimen demonstrated a statistically significant and clinically meaningful improvement in PFS for these patients compared to chemotherapy alone.
The study did not reach its secondary endpoint of overall survival (OS). The role of Keytruda in the intention-to-treat population remains uncertain at this time. The safety profiles of Keytruda and Lynparza were consistent with those observed in previously reported studies for the individual therapies. These results will be presented at an upcoming medical meeting and discussed with regulatory authorities.
About KEYLYNK-001; KEYLYNK-001 is a randomized, double-blind Phase III trial (ClinicalTrials.gov, NCT03740165 ) evaluating Keytruda in combination with chemotherapy (paclitaxel and carboplatin) followed by Keytruda with maintenance Lynparza, with or without bevacizumab, for the first-line treatment of BRCA non-mutated advanced epithelial ovarian cancer. The primary endpoints are PFS in patients whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10) and PFS in the intention-to-treat population. Secondary endpoints include OS and safety. The trial enrolled 1,367 patients who were randomized to receive:
- Keytruda (200 mg intravenously [IV]) plus chemotherapy every three weeks (Q3W) for five cycles, followed by Keytruda (200 mg IV Q3W for up to approximately two years) and Lynparza (300 mg orally twice daily);
- Keytrruda (200 mg IV) plus chemotherapy Q3W for five cycles, followed by KeytrudaA (200 mg IV Q3W for up to approximately two years) and placebo (orally twice daily);
- Chemotherapy plus placebo.
Patients who experience severe hypersensitivity reaction or an adverse event requiring discontinuation of paclitaxel may receive docetaxel plus carboplatin. Participants may also receive bevacizumab at the investigator’s discretion.
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
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