CHMP endorsed the immunotherapy combination for women in Europe with triple-negative, advanced cancers based on results from a Phase III trial reported last December.
The diagnostic can now be used to identify patients with head and neck squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
In the studies, the Merck immunotherapy extended survival for advanced lung cancer and stomach cancer patients with high PD-L1 expression.
The companies are using Strata's biomarker technology to identify genomic subpopulations of cancer patients who respond to Arcus' investigational immunotherapy drug.
The diagnostic can now be used to identify a wider range of patients with stage III or metastatic NSCLC who may benefit from first-line treatment with Keytruda.
In the JAMA study, researchers confirmed the previously known clinical and genomic features of NSCLC patients in their large clinico-genomics database.
Efforts highlighted at last week's AACR meeting included new efforts to advance gene expression signatures, improve PD-L1 tests, and calculate MSI across tumor types.
MSK researchers showed that high TMB may be associated with improved survival across tumor types, but the cut-offs for high and low status will vary based on histology.
New data on Kadcyla and Tecentriq will help doctors further refine precision medicine options for breast cancer patients with unmet needs.