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Foundation Medicine, MD Anderson Begin Second IMPACT Trial of Genomic Cancer Treatment

NEW YORK (GenomeWeb) — The University of Texas MD Anderson Cancer Center and Foundation Medicine will work together to conduct a randomized controlled trial to compare standard treatment with targeted therapies selected based on the molecular alterations in a patient's tumor.

Led by MD Anderson's Apostolia Tsimberidou, the study, IMPACT2, will evaluate whether genomically guided cancer care results in longer progression-free survival in patients with advanced disease.

According to MD Anderson, IMPACT2 builds on promising results from the first IMPACT trial, presented at the American Society of Clinical Oncology's annual meeting in 2011.

In IMPACT1, researchers were able to identify potentially actionable genomic alterations in 40 percent of the 1,144 patients enrolled. Within this subset, matching specific gene alterations to therapies resulted in a response in 27 percent of patients, while only 5 percent of those who received an unmatched treatment responded. Progression-free survival was also appreciably longer in the genomically treated group.

In the new study, Foundation Medicine will test study subjects using its comprehensive genomic profiling assay, FoundationOne, which detects a range of genomic alterations across 315 cancer-related genes, plus 28 other genes often rearranged in cancer.

According to MD Anderson, the use of this test, which covers more genes and alterations than the approach used in IMPACT1, should result in a larger percentage of study participants being eligible for targeted therapies.

While several commercial and academic providers have adopted broad genomic profiling to guide cancer therapy in recent years, the hope is that IMPACT2 will provide evidence necessary to support broader adoption of such testing across not only advanced, but also newly diagnosed metastatic tumors, Vincent Miller, chief medical officer of Foundation Medicine, said in a statement.

"If the results of IMPACT1 are confirmed, cancer treatment will be transformed and comprehensive molecular profiling will become the standard of care," Tsimberidou said.