Abstract
Identifying tumor biomarkers and characterizing their function in cancer cells help provide valuable data to guide the development and selection of personalized therapies and treatment plans for patients that may improve health outcomes and survivorship.
The pace of innovation in precision medicine testing technologies in oncology over the last decade has been truly remarkable. Tests for biomarkers in known driver genes including EGFR, KRAS, and ALK now help guide the selection of therapies that target those specific changes in solid tumors. 1
Developing single gene tests alongside the drug development process allows researchers to identify and enroll patients appropriate for targeted therapies in clinical trials much earlier. 2 Additionally, tests to assess tumor DNA fragments (called circulating tumor DNA, or ctDNA) in the blood may help provide valuable information on treatment response or identify high-risk, early-stage disease patients who may benefit from treatment. 3
One United States study of 17,555 people with advanced non-squamous non-small cell lung carcinoma examined overall survival and risk of mortality among patients who received biomarker-driven first-line therapy. 4 About 84% of patients in the cohort underwent biomarker testing. 4 Patients who underwent testing and received biomarker-driven therapy as a first-line treatment were likely to survive up to three times longer than those who did not. 4 Median survival was 18.0 months for those who received testing versus 6.0 months for those who did not receive testing. 4
The benefits of biomarker testing are well established, yet it is still frequently underutilized and inaccessible to some patients. One review of 814 non-squamous non-small cell lung cancer patients in 15 community oncology centers found that only 63 patients were tested for all seven markers (EGFR mutations, ALK fusions, ROS1 rearrangements, BRAF mutations, MET amplifications and mutations, RET rearrangements, and ERBB2 [HER2] mutations) recommended by the National Comprehensive Cancer Network. 5
Another review of data extracted from electronic medical records of 1,497 patients with metastatic colon cancer treated at 23 practices across the U.S., including both community and academic centers, found that guideline-aligned biomarker testing was completed in just 40% of patients. 6
Innovation in precision oncology testing and therapeutics
The industry has made significant progress in identifying unique gene and protein signatures that become targets for precision therapies and companion diagnostics in oncology. Over the last decade, AstraZeneca has prioritized personalized therapies for a diverse range of cancers, and today is a leading provider of precision oncology treatments. The company has also forged partnerships that push the boundaries of innovation in biomarker discovery and testing. Four pillars that are essential to the success of precision oncology underline AstraZeneca's approach to drug development:
Since 2014, AstraZeneca has launched several precision medicine therapies linked to different diagnostic tests that target biomarkers implicated in a range of solid tumor types, including breast and lung carcinomas. 3 Today the company's portfolio is focused on personalized medicine and AstraZeneca continues to expand its efforts in the space. 2
Enabling equitable access requires removing barriers to testing
Expanding systemwide access to biomarker testing requires a comprehensive approach to addressing challenges and structural barriers across the cancer care continuum that hinder utilization of biomarker tests for patients and physicians.
Tumor biomarker testing is faced with significant clinical and technical barriers such as suboptimal tissue procurement and triaging. In fact, insufficient sampling is frequently cited as a main cause for why biomarker reports cannot be generated. 7 Long test turnaround times as well as the complexity in test selection and interpretation are also factors that can discourage providers from pursuing testing for their patients. 7
The continuity of patient care across institutions also creates barriers to biomarker testing, as patients often seek care in different hospitals than the one in which they were originally diagnosed. 7 Hospitals may be hesitant to share tissue and data with other hospitals due to research incentives and logistical challenges. 7 In addition, inconsistencies in insurance coverage for biomarker test panels coupled with high out-of-pocket costs and delays in receiving approval for coverage may discourage some patients from undergoing testing. 7
Limited awareness about available biomarker tests and fragmented guidelines on their recommended use in practice also limit broad adoption. 7 The oncology testing and treatment landscape is evolving quickly, and it can be challenging for clinicians and patients to stay abreast of the rapidly growing number of biomarkers, molecular tests, and targeted therapies available today. 7 Solutions will need to be identified for overcoming barriers to testing, improving patient navigation, and disseminating clear and accurate information that advances the field.
Advancing precision oncology through collective action
Nearly 17 million people in the U.S. are living with cancer and more than one in three people will be diagnosed with cancer in their lifetime. 8 Improving health outcomes for these patients requires early and appropriate treatment informed by evidence-based testing. Regardless of cancer setting, tumor type, or disease stage, patients should have timely, accurate access to biomarker information related to their tumor type so that they can receive personalized treatment plans if eligible. Progress and innovation in precision therapy development has already made a difference for patients with melanoma, breast, lung, colon, and other cancers. Removing barriers and expanding access is crucial for enabling and broadening biomarker testing to deliver on the promise of precision medicine for even more patients and their loved ones.
