The trial will test two Bristol-Myers Squibb cancer drugs in patients with metastatic or unresectable tumors harboring mutations in the genes POLE and POLD1.
The pharma company plans to use the Signatera assay to determine whether it can identify patients who will respond to immunotherapy.
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 company's PD-L1 IHC 28-8 pharmDx diagnostic can now be used in cases of urothelial carcinoma and squamous cell carcinoma of the head and neck.
At the Personalized Medicine World Conference, stakeholders and the former FDA commissioner discussed how regulation can advance personalized medicine amid political uncertainty.
The recent failure of Bristol-Myers Squibb's lung cancer immunotherapy to meet its primary endpoint demonstrates the challenge of working with imperfect biomarkers.