RE:Biomarker driven trials in the era of precision medicinePrecision oncology refers to the study of the tiny details of tumours to find genetic changes that can be targeted with treatments.
Biomarkers are specific markers in the body that can help understand and treat the disease. Patients can be grouped based on how well they respond to treatments. This information can help doctors choose better treatments for patients and decide on who will benefit the most from these treatments. Cancer is unstable in its genetic makeup and, therefore, differs from patient to patient. This is why patients with the same type of cancer can have different outcomes and responses to treatment. Oncologists use biomarkers to provide patients with personalised treatment, which is what ONCY demonstrated with the AWARE-1 Phase 2 clinical trial. ONCY has now advanced these findings by filing a Type C meeting with the FDA to likley discuss how the biomarkers discovered can serve as surrogate endpoints that predictive treatment outcome, thus potentially leading to a FDA Accelerated Approval for pelareorep in the treatment of both metastatic pancreatic and breast cancers, +/- immune checkpoint inhibitors.
The advancements in research on single molecules or how cells interact with each other show that some drugs are more effective than others in the same category. Keytruda and Tecentriq are examples of other drugs used as precision treatment across multiple indications. CAR-T cell therapy is another being considered for the treatment of solid tumors.. However, not every drug fits into these groups the same way. Some therapeutic antibodies block a protein in cancer cells to stop their growth, and some find and kill cancer cells by carrying medicine to them, such a antribody drug conjugates (ADCs) which carry a chemotherapy payload, for example, into the TMA and to the tumor cell surface. However the slow release of chemotherapy in the TME and impaired cellular internalization results in T cell exhaustion and eventual cancer relapse. Doctors are using new treatments such as immunotherapy and targeted therapy to change how they treat cancer. These treatments provide different ways to help patients with the disease. However, there are several issues that still need to be resolved before cancer can be fully controlled. Some tumour cells can stay alive after treatment and become resistant to drugs, such as ADCs.
Consequently, precision oncology can reduce R&D costs and increase the ROI of oncology drugs, using companion diagnostics to select the most suitable patients for clinical trials and therapies. It could also use real-world data, such as electronic health records, to test the effectiveness and safety of treatments in diverse and representative populations. It could have a broader impact on cancer care if it also considers other molecular factors beyond the cancer genome, such as biomarkers, TiLs, predictive diagnostics, RNA and proteins, and integrates them into clinical and environmental data.