By: Hillary Theakston, Executive Director of The Clearity Foundation
In May, for the first time, the U.S. Food and Drug Administration approved a cancer drug for patients whose tumors are defined by a specific genetic feature (biomarker), rather than by the location in the body where the cancer originated — the lung, breast or colon, for example. This “site-agnostic” approach represents a triumph in the world of cancer care, acknowledging the fact that the molecular characteristics of a cancer are critical determinants of treatment response.
At the Clearity Foundation, where our focus is improving treatment decision-making for patients with ovarian cancer, we are optimistic that the FDA’s approval of Keytruda is a sign of many more individualized therapies to come. For nearly a decade, we have sought to advance the idea that tumor biology should be factored into treatment decisions for ovarian cancer, as it is with other oncology indications. This approach holds the promise of leading to more effective therapies customized to the patient.
Ovarian cancer is a heterogeneous cancer; the disease differs greatly from woman to woman. Few ovarian tumors share the same molecular characteristics, so one drug therapy simply won’t work for all patients. Clearity is the only organization empowering ovarian cancer patients with science-based information to make the most-informed treatment decisions, based on their unique tumor biology, clinical situation, genetics and priorities. Decades of research and clinical development have yielded too much knowledge about tumor biology to follow a one-size-fits-all approach to treating cancer.
While this is true of many forms of cancer, ovarian cancer stands out because it continues to have unacceptably poor survival rates and limited effective treatment options. The recent approval of a new class of drugs called PARP inhibitors has shown that it is possible to use molecular characteristics (for example, BRCA mutations) to select therapy for a subset of patients. This is encouraging progress, but the current treatment paradigm for ovarian cancer is still decades behind other cancers, and there is no routine diagnostic test to catch women in early stages of the disease.
Consider these statistics: Each year in the United States, 22,000 women are diagnosed with ovarian cancer and 14,000 women are lost to the disease. Only one-third of women diagnosed with ovarian cancer survive more than 10 years. The lives of far too many women are cut short, leaving painful gaps in our families, communities and workplaces.
The Clearity Foundation has supported more than 600 women in making scientifically backed treatment decisions by facilitating access to the most accurate and comprehensive tests available to better understand the molecular drivers of their cancer. Our profiling approach synthesizes and interprets data from multiple sources that measure specific protein biomarkers and detects certain genetic changes that are relevant in ovarian cancer. Oncologists are able to use our tumor blueprint to select drugs that match each patient’s individual disease. We provide the clinical research evidence underlying the drugs to be considered, and links to clinical trials that may also be options.
Women whose ovarian cancer has recurred will obtain the greatest benefit from a tumor blueprint since decisions regarding next-line treatment are less standardized than they are at diagnosis. Clearity can also assist newly diagnosed patients as they make decisions for their treatment.
The implementation of precision medicine is multi-faceted and requires many players working together: scientists, drug companies, government regulators, insurance companies and ultimately doctors. Clearity connects with these influencers as we seek to redefine the standard of care for ovarian cancer patients, many of whom are still being presented with the same drugs their grandmothers received.
Clearity has petitioned insurance companies to reimburse for new, targeted treatments for patients who are responding to drugs approved for other cancers. Now that FDA has embraced site-agnostic cancer drug approvals, we look to insurers to be more receptive to drug options that best suit the individual patient, adding fuel to the adoption of precision medicine and hope for the ovarian cancer community.
This article was digitally published on LinkedIn — please click here to read.