Precision Medicine in Oncology

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Four studies were highlighted that amplified the 3 components of using genetic testing in cancer treatment and prevention: (1) understanding the germline component of a tumor test, (2) broadening access to genetic counselors with video sessions, and (3) making sure risk assessment of each patient is accurate, so that patients do not have unnecessary surgeries.

We need the development of new, complex biomarkers to address the increasing complexity in treatment modalities that, in and of themselves, have characteristics of a continuous variable; they require innovation and outcomes data, which perhaps will be partly addressed by some of the emerging real-world evidence databases amassed by pairing sequence information and clinical outcomes. Tumor mutational burden is a great example of this innovation in practice.

The FDA today granted accelerated approval to the second biomarker-based indication for Merck’s pembrolizumab (Keytruda), an anti-PD-1 therapy, regardless of tumor type. A companion diagnostic to pembrolizumab, FoundationOne CDx was also today approved by the FDA as only approved companion diagnostic to measure tumor mutational burden.

The FDA approved Eli Lilly’s selpercatinib (Retevmo) capsules to treat non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other thyroid cancer tumors. The treatment is indicated for patients whose tumors have an alternation, such as a mutation or fusion, in a specific gene (RET or 'rearranged during transfection'), marking the first approval of a therapy for cancer patients with the RET gene alterations.