NIH Pushes Forward On Precision Medicine With Genome-Based Cancer Drug Project

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Today, the National Institute for Health unveiled an ambitious new program that will attempt to map hundreds of known cancer-related genetic mutations with currently available cancer drugs. The program, called NCI-MATCH: Molecular Analysis for Therapy Choice, is being managed by the National Cancer Institute and was unveiled this week at the the American Society of Clinical Oncology in Chicago. The underlying goal of the project is to determine if specific drugs are effective at treating cancers with the same gene mutations regardless of the cancer type.

The study has been designed as a phase II trial with 10 sub-studies running in parallel. The research team reports that within the first year, it is expected that there will be more than 20 sub-studies running within the program. Patients will be recruited for the program through 2,400 feeder sites across the US. At these sites, patients with cancers that have not responded to existing treatments, or for which no treatment exists, will have their tumor biopsied and genetically sequenced to identify the gene mutations present. To facilitate testing, the NCI Frederick National Laboratory for Cancer Research has created a sequencing test that looks for 143 mutations that will be treated during the trial. Because genetic mutations are rarely discovered in tumors, it is expected that enrolled patients will only have one or, at most, two treatable mutations in their tumors, but for those that have two researchers will be able to experiment with using multiple therapies concurrently to control the tumor.

If a molecular abnormality is found that a sub-study is focusing on, the patient will be enrolled in that sub-study. At this point, the patient’s cancer will be treated with a specific drug treatment for as long as the tumor continues to shrink or remain stable. Drugs include currently available FDA-approved cancer treatments, as well as investigational therapies still being tested by pharmaceutical companies. If a patient’s tumor continues to grow, their participation in the trial will end and their oncologists will consult with them on possible alternative treatment options.

The study will measure two key metrics: the percent of patients whose tumors shrink as a result of the treatment, and the 6-month, progression-free survival rate of the patients enrolled in the studies. To identify drug-gene mutation combinations worth further investigation, researchers have agreed that additional research will be conducted for any studies resulting in either 16-25 percent of enrolled patients showing tumor shrinkage, or 35 percent meeting the six-month survival threshold.

Enrollment into the trials will begin in July, and NCI hopes to recruit more than 1,000 participations throughout the life of the project.


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