Although the FDA has already approved the regimen in this indication after seeing its impact on progression-free survival, the latest data speaks to its impact on survival.
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.
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.
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.
