The projects, organized by Friends of Cancer Research in the US and the Quality Assurance Initiative Pathology (QuIP) in Germany, are comparing different TMB assays.
Presentations largely reflected negatively on the utility of PD-L1 for stratifying response, but pivotal new data on tumor mutational burden as assessed by Foundation Medicine's genomic sequencing panel.
The companies plan to develop a broad NGS panel to analyze all known biomarkers for cancer drugs, including tumor mutation burden and microsatellite instability.
With multiple independent biomarkers, and potential combinations that may require even more subtyping, diagnostics to guide immunotherapy appears to be getting more complicated.
BMS amended an ongoing Phase III study of Opdivo and Yervoy to evaluate outcomes based on tumor mutational burden using Foundation Medicine's NGS companion diagnostic.
The partners will use the GuardantOMNI assay, a 500-plus-gene liquid biopsy panel designed to accelerate clinical trials and targeted cancer therapy research.
Qiagen will use NGS to develop gene expression profiles related to BMS immuno-oncology therapies; and the company has licensed IO therapy response biomarkers from JHU.
The firms will use the FoundationOne assay to characterize tumors and their microenvironment to find predictive measures of response to cancer immunotherapies.
