Over the past decade, precision medicine has garnered significant attention from the oncology community. By delivering therapies to patients most likely to benefit, precision medicine approaches have dramatically improved the outlook for patients across many tumor types, particularly in advanced non-small cell lung cancer (NSCLC). Increased interest stems from enhanced testing technologies, a greater understanding of molecular disease drivers and a growing number of treatments targeting these underlying causes of cancer.
“Across the biopharmaceutical industry, we are seeing a growing arsenal of precision therapies with the potential to transform care for more people living with cancer,” said Philina Lee, Ph.D., vice president of Marketing and Precision Medicine at Blueprint Medicines, which develops targeted treatments for cancers and rare diseases. “A key to delivering on this promise is overcoming the barriers to accurately identifying patients who may benefit from precision medicine. The rapid advancement of precision therapies serves as a call to action to enable comprehensive biomarker testing for all patients with advanced non-small cell lung cancer prior to treatment decisions.”
Webcast: The Promise of Using Biomarker Testing to Inform Treatment Decisions in NSCLC
Lee will moderate a precision oncology virtual roundtable hosted by Blueprint Medicines on September 29, 2020 and discuss practical ideas to help more advanced NSCLC patients who may benefit from precision medicine. The panel will feature perspectives from leading healthcare stakeholders, including oncologists from a large comprehensive cancer center and community oncology practice. To register, click here.
Transforming clinical outcomes with precision therapy approaches
Testing for and identifying actionable biomarkers is proven to optimize treatment and patient outcomes. Multiple studies have shown that the use of biomarker testing and resulting ability to give precision therapies lead to significantly better overall survival.1,2
The number of known molecular drivers that lead to cancer continues to increase. There are also more targeted treatment options available today than ever before. About 35 percent of NSCLC patients have one of seven biomarkers that can now be targeted with an FDA-approved therapy.3,4 These molecular drivers of cancer with approved therapies include EGFR, ALK, ROS1, BRAF, NTRK , MET and RET. Other biomarkers, like KRAS, have potential targeted treatments being studied in clinical trials.
Tumors with other biomarkers, such as high tumor mutation burden or PDL-1 status, benefit most from immuno-oncology approaches. Recently, the first immunotherapy received FDA approval for solid tumors with high tumor mutation burden, regardless of where the cancer is located in the body. However, patients whose tumors have known molecular drivers tend to have worse outcomes with single agent immunotherapy.
Identifying the right patient for the right treatment
Approaches like next-generation sequencing are an important way to test for many biomarkers at once. With seven actionable biomarkers associated with FDA-approved therapies, we have reached a tipping point for using broad panel-based diagnostic approaches rather than sequential, single gene testing, which poses challenges such as the potential to run out of tissue or to prolong turnaround times for results.
Despite the benefits of precision medicine, there are significant differences in how healthcare systems act on testing results and prescribe precision therapies. The number of patients with an actionable biomarker who receive targeted therapy ranges from more than 90 percent at institutions such as Cedars-Sinai Medical Center5 to less than 50 percent in some community settings.6
There are challenges to implementing biomarker testing as a standard of care, particularly in community oncology practices and hospitals. However, multi-disciplinary stakeholders are continuing to remove these barriers as precision medicine approaches evolve:
- There is a continued rise of precision medicine initiatives, with medical centers increasingly developing guidelines for who, when and how to test, as well as how to act on the results.
- Enhanced interoperability of health systems means testing results are more accessible to clinicians across a network of centers.
- Testing reimbursement is becoming more widespread since the Centers for Medicare and Medicaid Services instituted a final National Coverage determination, supporting reimbursement of a next-generation sequencing test across all solid tumors.
Looking ahead, the future of precision medicine in oncology is promising, and this approach may significantly alter the treatment path for many patients. “This is an exciting time in the history of precision medicine,” explained Lee. “We have a tremendous opportunity, as well as an imperative for cooperation across the healthcare ecosystem, to improve the lives of patients with advanced non-small cell lung cancer.”
1 Barlesi F, Mazieres J, Merlio JP, et al. Routine molecular profiling of cancer: results of a one-year nationwide program of the French Cooperative Thoracic Intergroup (IFCT) for advanced non-small cell lung cancer (NSCLC) patients. Lancet. 2016;287(10026):1415-1426.
2 Kris MG, Johnson BE, Berry, LD, et al. Using Multiplexed Assays of Oncogenic Drivers in Lung Cancers to Select Targeted Drugs. JAMA. 2014;311(19):1998-2006.
3 Hirsch FR, Scagliotti GV, Mulshine JL, et al. Lung cancer: current therapies and new targeted treatments. Lancet. 2017;389(10066):299-311.
4 LUNGevity Foundation. Targeted therapy. https://lungevity.org/for-patients-caregivers/lung-cancer-101/treatment-options/targeted-therapy. Accessed August 7, 2020.
5 Makhoul E, Kim JT, Zhang W, et al. Biomarker utilization in non-small cell lung cancer, are we treating after testing? J Clin Oncol. 2020;38(suppl;abstr 9609).
6 Gierman HC, Goldfarb S, Labrador M, et al. Genomic Testing and Treatment Landscape in Patients with Advanced Non-Small Cell Lung Cancer. J Clin Oncol. 2019;37(suppl;abstr 1585).