Precision Medicine in Oncology

January 4, 2016
Precision Medicine in Oncology
The White House has proposed $70 million in increased funding for the National Cancer Institute to advance the field of precision oncology. [iStock/KatarzynaBialasiewicz]

Patricia Fitzpatrick Dimond

In his 2015 State of the Union address, President Obama stated his intention to fund a national Precision Medicine Initiative (PMI), defined by the NIH as an emerging approach for disease prevention and treatment that takes into account individual variations in genes, environment, and lifestyle.

The White House said that it will ask Congress for $215 million to fund the assembly of databases. Through the data, from over one million patients, scientists and researchers will be able to individualize care and generate the requisite scientific evidence to move the concept of precision medicine into clinical practice.

The initiative, in the near-term, focuses on cancer, with other disease areas included over the longer term. Of the $215 million, the White House proposed $70 million in increased funding for the NCI to advance the field of precision oncology.

Basically the initiative funds efforts to integrate and apply the explosion of molecular data on humans, particularly data associated with individual patients, and taps into opportunities to use it to improve health outcomes. The “time is right” for the initiative, NIH says, because of the sequencing of the human genome, improved technologies for biomedical analysis, and new tools for using large datasets.

The NCI launched its Precision Oncology Initiative to address two historical problems, as described by James H. Doroshow, M.D., deputy director for clinical and translational research at the NCI, at a June, 2015 presentation at a National Cancer Advisory Board and NCI Board of Scientific Advisors joint meeting. These, he said, are that cancer treatment for 70 years has relied on drugs “marginally more toxic” to malignant cells than to normal tissues, and that molecular markers to predict benefit or understand therapeutic resistance have “usually been lacking.” Dr. Doroshow said the proposed solution to these problems is to identify and target “molecular vulnerabilities” of various cancers.

NCI kicked off its program with four clinical trials in 2014: ALCHEMIST, a Phase III randomized trial for non-squamous, non-small cell lung cancer; Lung MAP, a Phase II and III randomized trial for second-line squamous lung cancer treatments; M-PACT, a pilot trial for refractory solid tumors; and an Exceptional Responders Initiative to study the less than 10% of patients who do well on otherwise failed-trial drugs.

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