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Again, Keytruda and PARP fail to lynk

More evidence, as if it were needed, that PARP inhibition adds no benefit to Keytruda in lung cancer came today with the failure of Merck & Co’s Keylynk-006 study. This concerned Keytruda plus Lynparza in first-line non-squamous NSCLC, and came three months after the failure of Keylynk-008, a broadly similar trial in front-line squamous NSCLC. Launching such phase 3 studies always seemed surprising given the lack of scientific support; indeed, the phase 2 PIN trial testing Lynparza versus placebo in NSCLC maintenance yielded no statistically significant increase in PFS, while the phase 2 ORION study, testing AstraZeneca’s Imfinzi plus Lynparza as first-line NSCLC maintenance, also disappointed on PFS. A separate Keytruda/Lynparza combo study in prostate cancer, Keylynk-010, was stopped for futility two years ago. Still to read out in lung cancer are Keylynk-012 and 013, and given the precedent hopes here can’t be high. A postmortem of Keylynk-008 is due to be presented at a minisymposium during next month’s AACR conference.

 

Keytruda/Lynparza combo trials in lung cancer

StudySettingDesignPrimary endpoints/outcome
Keylynk-0081L squamous NSCLCKeytruda + chemo, then Keytruda + Lynparza maintenanceFailed on OS vs Keytruda + chemo
Keylynk-0061L non-squamous NSCLCKeytruda + chemo, then Keytruda + Lynparza maintenanceFailed on PFS & OS vs maintenance chemo
Keylynk-012Stage III NSCLCKeytruda + chemoradioation, then Keytruda +/- LynparzaPFS & OS vs chemoradiation + Imfinzi, ends 2026
Keylynk-0131L SCLCKeytruda + chemoradioation, then Keytruda +/- LynparzaPFS & OS vs chemoradiation, ends 2027

Source: OncologyPipeline.

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