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Experimental EGFR inhibitor fell short of desired objective response rate in patients with non-small cell lung cancer.
The drug is designed to tackle C797S resistance mutations that arise in NSCLC patients after treatment with third-generation tyrosine kinase inhibitors.
The company is enrolling up to 400 patients in its LIBRETTO-431 trial to evaluate survival and response to selpercatinib.
The approval is based on a Phase III trial showing that Tecentriq significantly improved survival in patients with metastatic non-small cell lung cancer.
The results are of interest to drugmakers looking for scalable technology solutions for assessment of PD-L1 for predicting immunotherapy response.
The company will use its InVisionFirst-Lung test to study resistance mutations in patients treated with Pfizer's ALK inhibitor lorlatinib.
The grant will co-fund a year-long project to validate Biofidelity's chemistry to detect mutations used to guide non-small-cell lung cancer treatment.
The assay was developed in partnership with Merck and is intended as a companion diagnostic for that firm's anti-PD-L1 immunotherapy.
Two KEYNOTE studies showed TMB may have some utility in determining which NSCLC patients should get pembrolizumab, while three others showed no utility.
The team identified six independent DNA methylation blocks that could potentially help to predict the formation of central nervous system metastases in lung cancer.