Genomic biomarkers have fundamentally changed how we treat cancer. Not only do they help physicians reduce uncertainty and improve outcomes by identifying the right treatment for the right patient, they also have the potential to make a huge impact on drug development and clinical trial success. To maximize their value for patients, physicians, biopharma innovators and payers alike, we need to improve access to the latest technologies fueling this revolution in personalized medicine.
Two innovative treatments
Comprehensive genomic profiling (CGP) is one of these technologies. CGP has rapidly accelerated our understanding of cancer and our ability to match more effective therapies to the unique genomic profile of each individual. But unfortunately, CGP is not an option for many patients, particularly those outside of major academic medical centers. Improving access to CGP will be essential to continuing the progress the cancer community has made thus far on personalizing care.
The oncology community is at a unique moment in history that could once again prove transformational for the cancer treatment landscape. Genomics is redefining cancer care in unprecedented ways, as exemplified by the recent approval of pembrolizumab for tumors with high microsatellite instability and the potential approval of entrectinib for NTRK-positive tumors, regardless of location within the body. Cancer is now being defined by its genomic alterations, not its tissue of origin, underscoring the urgency of making CGP available to everyone diagnosed with cancer.
Steps in the right direction
One important step toward this goal was the FDA approval of FoundationOne CDx™, the first FDA-approved CGP assay for all solid tumors that was also reviewed by both the FDA and CMS in their Parallel Review program. This means that along with FDA approval, Foundation Medicine received a preliminary National Coverage Determination for FoundationOne CDx which, when final, may help make personalized medicine more accessible to Medicare beneficiaries. We believe this historic decision represents an important shift in how our policymakers approach access to personalized care in cancer.
The power of collaboration
This access is also being fueled by the power of collaboration and data-sharing, in accordance with patient confidentiality guidelines. Vice President Biden’s historic Cancer Moonshot policy paved the way to breaking down information silos and accelerating data access with the goals of progressing research and getting new therapies to patients faster. SmartTrials™, for example, is a novel platform designed to build both awareness of target-matched trials and enable access for patients being treated in community care settings. The SmartTrials engine automatically identifies patients with select, actionable genomic findings to facilitate access to clinical trials. In one case, a patient was identified, screened and enrolled in a trial within only seven days. In contrast, traditional paths to enrollment can take months, often too long for many cancer patients who need treatment urgently.
This policy platform also stimulated an unprecedented wave of data sharing. For our part, Foundation Medicine contributed genomic data from 18,000 cancer cases to the National Cancer Institute’s Genomic Data Commons – nearly doubling the data previously available for research.
CGP is poised to transform cancer care, but only if patients have access to its benefits. Through rigorous science, advanced technologies and increased collaboration and data sharing, we believe the promise of personalized oncology can become a reality for as many people as possible.
