Keytruda/Lynparza link-up disappoints again

On Monday Merck & Co was spinning the Keylynk-001 trial as the first positive phase 3 for Keytruda plus Lynparza, but things are still far from rosy for this star-crossed combo. Although the study met its primary endpoint of progression-free survival, it missed on the key secondary of overall survival; full data will come at a future medical meeting. The question now is whether this will be enough to get approval for the use in question, first-line BRCA non-mutated ovarian cancer. While Keytruda isn't indicated for ovarian cancer, Lynparza is marketed here in various maintenance settings in BRCA-mutant patients; Keylynk-001 is therefore an attempt by Merck to expand into ovarian cancer white space. Specifically, the trial tested Keytruda plus chemo, followed by Keytruda plus Lynparza maintenance, with or without Avastin; this regimen was compared versus chemotherapy alone. The primary endpoints were PFS in patients with PD-L1 expression of ≥10%, and PFS in the intent-to-treat population. The stumble comes after various Keylynk failures, many of them in lung cancer, most recently Keylynk-006 in first-line non-squamous NSCLC. Yet to read out are Keylynk-012 in stage III NSCLC, and Keylynk-013 in first-line small-cell lung cancer, but hopes cannot be high.

Phase 3 Keylynk trials of Keytruda + Lynparza

Source: OncologyPipeline & clinicaltrials.gov.