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Largest Ever Precision Oncology Trial Takes Novel Approach to Cancer Treatments

June 5, 2015

Nurse and Patient Talk at Doctor's Office

When President Barack Obama announced his ambitious plan to bolster personalized medicine research in the U.S., many critics were skeptical of the claims. A total of $215 million in the 2016 budget would be earmarked for use by the Precision Medicine Initiative, the administration announced in a January 2015 press conference, with nearly $70 million alone going to the National Cancer Institute (NCI) for advanced research on genomic causes of the disease.

Though politicians can be known for empty promises, a recent press release from the National Institutes of Health (NIH), parent to the NCI, proves that there is serious intent behind the effort to reinvigorate personalized medicine research. At the recent annual meeting of the American Society of Clinical Oncology in Chicago, NCI officials announced the formation of NCI-MATCH: Molecular Analysis for Therapy Choice. In a novel approach to cancer treatments, NCI-MATCH will investigate whether treating patients based on similarities in the genetic irregularities in tumors rather than cancer type yields improved results.

Scaling Up Research Efforts
Co-developed by the NCI and partner institutions including the ECOG-ACRIN Cancer Research Group, NCI-MATCH will function as a phase II trial that begins with 10 substudies. After a few months, officials explained that they expect to bring that number up to 20 or more.

"NCI-MATCH is a unique, ground-breaking trial," Doug Lowy, M.D., acting director of the NCI said in a statement. "It is the first study in oncology that incorporates all of the tenets of precision medicine. There are no other cancer clinical trials of this size and scope that truly bring the promise of targeted treatment to patients whose cancers have specific genetic abnormalities. It holds the potential to transform cancer care."

Though patient enrollment is not expected to begin until July, the details on the participation process have already been released. Patients will first provide biopsies of tumor tissues, which researchers will put under DNA sequencing to identify genetic anomalies shared among the subject population. Once commonalities are found, those patients will be evaluated for eligibility and entrance to the appropriate substudy that will investigate the specific mutation in detail.

Rather than limiting the search for genetic mutations in tumors on an individual basis, which is costly and inefficient, the NIH's press release explained that researchers will instead use "advanced gene sequencing techniques" to detect as many nonstandard expressions as possible.

Large-Scale Study Means Help From All Directions
More than 2,400 research centers will be mobilized as part of the first ten arms of the study, and an expected 3,000 patients will submit tissue samples for analysis during the full course of the trial. To support such a monumental effort, pharmaceutical manufacturers have already volunteered commonly prescribed cancer drugs to the study at no extra cost, ABC News reported. AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech, and Pfizer have committed to providing a minimum of 13 medications to study participants who qualify based on the results of their tumor biopsies.

"We are getting to the lowest common denominator [of cancer,]" Otis Brawley, M.D., chief medical officer of the American Cancer Society told ABC News, though the ACS is not involved in NCI-MATCH. "You might end up with 30 people, all with different kinds of cancer, getting the same drug."

Though the results of NCI-MATCH are, at the very least, months away, a successful outcome for even a single intervention would be groundbreaking. The U.S. Food and Drug Administration has never approved a cancer medication that was not aimed at a specific tumor type, but the validation of a qualified catch-all drug could help millions of patients across the country and, perhaps, the world.