Guest Blog
by Jennifer Levin Carter, M.D., M.P.H., Founder, Chief Medical Officer, N-of-One

The pace of scientific development is proceeding unlike any other time in the history of health care. New technologies, diagnostic tests and drugs are being introduced at record speed. However, to keep abreast of this unprecedented progress and to realize the value of personalized medicine, physicians must be empowered to efficiently and effectively utilize molecular testing to match patients with the most promising treatments.  This is not getting easier — physicians must have access to accurate, timely and cost-effective clinical interpretation to enable the delivery of data-driven therapeutic strategies to every patient.

Oncology is leading the way in the personalized medicine revolution. The oncology pipeline has expanded by 63 percent over the past 11 years,¹  and oncology drugs accounted for 50 percent of all personalized medicines approved in 2016.² Approximately 80 percent of cancer drugs in the pipeline are first-in-class therapies, and 73 percent target a specific biomarker.³ With this wave of new treatment options, how do physicians match their patients to the best possible therapy?

Much of the advancement in oncology drug development is a result of the uptake of next-generation sequencing in the clinic, and there is growing recognition that other molecular tests, like those evaluating copy number, fusions and protein expression, are becoming important tools for predicting response to therapies. New predictive tests for evaluating the efficacy of immunotherapies are in the pipeline. As patients are treated with targeted therapies and immunotherapies, novel resistance mutations, such as the EGFR C797S mutation after treatment with Osimertinib for EGFR T790M positive non-small cell lung cancer, are beginning to appear. Liquid biopsy tests have become a powerful method for identifying these mutations, especially in the absence of accessible tumor for biopsy. The results from these tests, if correctly interpreted, can prevent treatment with therapies that are no longer working.

Although this explosion of complex molecular data is vital for the advancement of personalized medicine in oncology, it also represents a critical challenge for clinicians. PMC’s Health Care Working Group notes that “to be successful, providers must deliver information about the significance of test results in a way that saves time and resources and allows for expansion that can keep pace with the rate of scientific advancement.”⁴

Due to the growing complexity of the molecular data and available therapeutic options, patient-specific clinical interpretation is required for helping the physician utilize molecular testing to select a therapeutic strategy for each patient. Each patient’s molecular test results must be analyzed to assess the effect of the clinically relevant alterations and the combination of alterations in the context of each patient’s cancer sub-type to determine the link to relevant therapeutic strategies. This must include sophisticated clinical trial matching.⁵

The key capabilities for patient-specific clinical interpretation necessitate:

1. Analysis of each patient’s molecular profile at the gene, variant and disease level, plus an assessment of the impact of the interactions between alterations on drug sensitivity, drug resistance and combination therapy. This requires oncology domain expertise for on-demand analysis to evaluate any type of cancer and assess novel mutations
2. Up-to-date clinical trial matching to address the growing complexity of patients’ molecular data and clinical trial design
3. Capabilities to update a patient’s analysis based on subsequent testing and evolution in the molecular profile
4. Integration of multiple types of tests to create a coherent treatment strategy, including immunotherapy approaches
5. Integration of relevant patient data into the clinical interpretation to further refine clinical trial matching
6. Delivery of therapeutic strategies to the point of care at the time of decision-making through the electronic medical record to enable physician-patient discussion

We as an industry can seize upon the opportunity to personalize the care of every patient. Molecular testing can play an increasingly valuable role in the diagnosis and treatment of disease. But for each patient to effectively receive this type of care, physicians must be empowered with exceptional clinical interpretation.

1 IMS Institute for Healthcare Informatics. Global Oncology Trend Report: A Review of 2015 and Outlook to 2020. June 2016. http://www.imshealth.com/en/thought-leadership/ims-institute/reports/global-oncology-trend-report-a-review-of-2015-and-outlook-to-2020. Accessed June 3, 2016.
2 Personalized Medicine Coalition. Personalized Medicine at FDA: 2016 Progress Report. 2017. http://www.personalizedmedicinecoalition.org/Resources/Personalized_Medicine_at_FDA. Accessed February 5, 2017.
3 Pharmaceutical Research and Manufacturers of America. Medicines in Development for Cancer: From Hope to Cure. 2015. http://phrma.org/sites/default/files/pdf/oncology-report-2015.pdf. Accessed May 15, 2016.
4 Pritchard, DE, Moeckel, F, Villa, M, Housman, L, McCarty, C, McLeod, HL. Strategies for integrating personalized medicine into health care practice. Personalized Medicine. Vol. 14, No. 2, 2017. Available at http://www.futuremedicine.com/doi/abs/10.2217/pme-2016-0064.
5 Carter, JL. Empower physicians to deliver precision medicine: The role of clinical interpretation. Personalized Medicine Coalition. Education & Advocacy. 2015. Available at https://personalizedmedicine.blog/2015/11/17/empowering-physicians-to-deliver-precision-medicine-the-role-of-clinical-interpretation/.