The study showed that patients with targetable genomic markers, especially HER2 alterations, responded well to chemotherapy-free treatments.
The analysis also suggested ways to outwit these mechanisms based on the degree of immune cell infiltration into the tumor.
The groups have written draft recommendations and are now asking for public comment from pathologists and other stakeholders.
The study of cancer immunity biomarkers revealed complex immune profiles for most tumors, suggesting the need for customized combinations of immunotherapies.
The FDA had previously approved neratinib as an extended adjuvant therapy for patients with early-stage HER2-overexpressed or amplified breast cancer, following adjuvant treatment with trastuzumab.
Genetron will provide clinical trial genomic testing and companion diagnostic development services for InnoCare's biomarker-driven oncology drug development.
The Phase I trial is hosted at two locations in Europe and will enroll up to 60 patients whose tumors overexpress the PI3K delta protein.