Researchers are increasingly arguing that the tissue-agnostic approval was too broad, and that tumor mutational burden is only a biomarker of response to immunotherapy in a handful of cancer types.
The CHMP opinion is based on data from a Phase I/II study of dostarlimab in mismatch repair-deficient or microsatellite instability-high endometrial cancer.
The European Commission approved Merck's PD-1 inhibitor as a frontline therapy for this patient population based on the results of the Keynote-177 trial.
A recent paper details how, across several cancer types, high TMB is associated with improved outcomes with immunotherapy but worse outcomes without it.
The European Commission will review CHMP's opinion based on the Keynote-177 data and is expected to issue a final decision in the first quarter of 2021.
The new consortium is aiming to make comprehensive genomic profiling accessible to advanced cancer patients in the US, to help inform their treatment decisions.
Researchers are continuing to collect data on economic, racial, and other factors that could be addressed to make precision medicine access more equitable.
Promega will develop its microsatellite instability assay as a companion diagnostic for Incyte's anti-PD-1 drug candidate retifanlimab in endometrial cancer.
