Merck’s subQ Keytruda headscratcher

Awaiting the readout of a pivotal trial of subcutaneous Keytruda – a blockbuster lifecycle extension – why has Merck & Co just put this formulation into a new mid-stage study? The phase 2 Keynote-F65 trial is to start enrolling 60 lymphoma patients in mid-August, according to a recently posted clinicaltrials.gov entry. The answer, says Evercore ISI’s Umer Raffat, is that the pivotal Keynote-D77 lung cancer study can only support US approval across IV Keytruda’s current solid tumour indications, so a separate test is necessary for blood cancers, where Keytruda is approved for classical Hodgkin lymphoma. No such distinction is apparently necessary for EU approval. This addition comes against the backdrop of bigger changes in a space where Merck earlier abandoned plans for a SC formulation without hyaluronidase in favour of the current one, coded MK-3475A. Bristol has filed SC Opdivo with the FDA, and recently succeeded in having its PDUFA date brought forward from February 2025 to December 2024. Roche’s SC Tecentriq filing was knocked back, and after being resubmitted it now faces a 15 September action date. And AstraZeneca, which was already playing down the relevance of SC Imfinzi, has now terminated this project.

Selected subcutaneous PD-(L)1 projects in the clinic

Source: OncologyPipeline.