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NIH Precision Medicine Clinical Trial Releases New Findings

The findings could enhance future cancer research and bring precision medicine to patients with rare types of cancer.

NIH precision medicine clinical trial releases new findings

Source: Thinkstock

By Jessica Kent

- The National Cancer Institute’s Molecular Analysis for Therapy Choice (NCI-MATCH) trial, the largest precision medicine trial of its kind, has released results from several sub-studies that could bring targeted treatments to patients with certain gene abnormalities, no matter their cancer type.

Findings from three sub-studies were released at the American Society of Clinical Oncology’s (ASCO) annual meeting in Chicago this year, adding to results released from one sub-study in November of 2017.

NCI of the National Institutes of Health (NIH) and the ECOG-ACRIN Cancer Research Group of the NCI-sponsored National Clinical Trials Network (NCTN) developed the study.

NCI-MATCH is a phase 2 clinical trial that was launched in August 2015. The trial aims to determine whether targeted therapies for patients whose tumors have certain gene mutations will be effective, regardless of their cancer type.

Researchers used a DNA sequencing test to identify gene mutations in patients’ tumors. The test looked for mutations in 143 genes associated with cancer that can be targeted by one of the drugs studied in the trial.

“NCI-MATCH represents the first attempt to systematically leverage next-generation sequencing to explore so many therapies in parallel,” said ECOG-ACRIN study chair Keith T. Flaherty, MD, a medical oncologist at Massachusetts General Hospital Cancer Center in Boston.

“By focusing our investigational effort on new biomarker-guided therapies in understudied cancer types, we have accelerated the opportunity to find signals of efficacy.”

There are nearly 40 sub-studies of NCI-MATCH, and each is aimed at enrolling at least 35 participants whose tumors have a specific genetic change. Several additional sub-studies are being developed for possible opening later in 2018.

Promising treatments can advance to larger, more definitive studies outside of the trial. NCI-MATCH is designed for adults with solid tumors, lymphoma, or myeloma that have progressed on standard treatment or rare cancers for which there is no standard treatment.

Researchers aimed to enroll at least 25 percent of participants with rare cancers in NCI-MATCH. The trial greatly exceeded this goal, with 62.5 percent of the first 6,000 patients having tumors other than the four most common cancers.

Findings released from the first of the three sub-studies, which examined the effects of the drug taselisib in 65 patients, showed that 24 percent of participants experienced a prolonged stable disease period of greater than six months. This occurred even in patients with aggressive cancer types, suggesting that the drug warrants future research.

The second sub-study looked at the drug ado-trastuzumab emtansine. In three of the 37 participants, each of whom had a rare type of cancer, tumors shrunk by at least 30 percent. Additionally, 46 percent of patients experienced a stable disease period, leading researchers to conclude that further study of the drug would be beneficial.

The third sub-study of NCI-MATCH observed 50 patients taking the drug AZD4547. Ten percent of patients experienced tumor shrinkage of at least 30 percent. Four of these patients had similar gene mutations, indicating that these mutations may be particularly sensitive to the drug.

Considering that many of the patients in these three sub-studies had been treated with more than three lines of therapy prior to enrollment, these results are especially encouraging.

Researchers anticipate that the findings from NCI-MATCH will improve the future of precision medicine and treatment of patients with rare forms of cancer.

“The outcomes data being released today from this groundbreaking precision medicine trial are an exciting step for NCI-MATCH,” said Lyndsay Harris, MD, of NCI’s Cancer Diagnosis Program and NCI study chair.

“These findings represent a large collection of data in populations of patients who may not have been studied in conventional clinical trials, and they will have important implications for future precision medicine trials.”

Results of additional sub-studies will be released on a rolling basis. The trial is ongoing and is enrolling patients at over 1100 cancer centers and community hospitals across the country.

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