Merck gets high with subcutaneous Keytruda

A week after Merck toplined a pivotal win with subcutaneous Keytruda, more details have emerged about an upcoming phase 3 study in high PD-L1 expressers. A clinicaltrials.gov entry is now available for the Keynote-F84 trial, which is set to enrol first-line NSCLC patients with PD-L1 levels of 50% or higher; Keynote-D77, which prevailed last week, also in first-line NSCLC, makes no mention of PD-L1 expression. However, Keynote-D77 tested Keytruda plus chemo, while Keynote-F84 is evaluating monotherapy; full results from the former are due at an upcoming medical meeting, likely next year. It’s unclear whether Keynote-F84, which will pit SC Keytruda against the approved intravenous formulation and is set to start by the end of this month, will include any US patients: sites are currently listed in China, South Korea, Poland and Romania. Keynote-D77 was designed to support the filing of SC Keytruda (also known as MK-3475A) in all intravenous Keytruda’s solid tumour indications; a spokesperson for Merck told ApexOnco that the start of Keynote-F84 doesn't herald a change in its regulatory strategy. The company is also carrying out Keynote-F65 to support haematological cancer uses, and a patient preference trial is due to complete next year.

Phase 2 & 3 trials of subcutaneous Keytruda

Source: OncologyPipeline & clinicaltrials.gov.

This story has been updated.