Partnering to create custom-made medicine

A tailor-made suit sewn to fit a customer’s exact measurements almost always fits better than one purchased “off the rack.”

Researchers at MD Anderson are applying this same logic to cancer medicine, where tumors from patients with difficult-to-treat cancers are individually analyzed, then drugs and other therapies are prescribed to attack each tumor’s one-of-a-kind genetic and molecular makeup.

To demonstrate that this form of therapy, known as “targeted therapy” or “precision medicine,” improves outcomes in patients with advanced cancer compared to more traditional treatments, MD Anderson is conducting a randomized, controlled trial in partnership with Foundation Medicine, a Massachusetts company that provides genomic profiles to oncologists to help them match their patients to targeted therapies.

The trial’s goal is to show that targeted therapy results in longer, progression-free survival in patients with advanced disease, and to expand the use of targeted therapy across all types of cancer. Currently, targeted therapy is mainly reserved for patients with specific cancers that have failed to respond to more generic forms of treatment such as chemotherapy.

Known as the IMPACT2 (Initiative for Molecular Profiling and Advanced Cancer Therapy) trial, the study builds on promising results from the first IMPACT trial, presented at the American Society of Clinical Oncology’s Annual Meeting in 2011.

In the IMPACT1 study, researchers found that 40% of the 1,144 patients enrolled had an identifiable genomic alteration. By matching specific gene alterations to therapies, 27% of patients responded, compared to 5% with an unmatched treatment, and progression-free survival was appreciably longer in the matched group.

This early data enabled many cancer centers and oncologists to begin using targeted therapy as standard practice in patients for whom existing diagnostic and treatment options are inadequate, such as patients with non-small cell lung cancer, or patients whose cancers arise from unknown primary or rare tumors.

The Impact2 study, led by Apostolia Maria Tsimberidou, M.D., Ph.D., is an effort to further validate earlier findings from Impact1.

Expanding targeted research will help match patients for clinical trials of new medications, and will reduce the cost and time necessary to conduct those trials, said Tsimberidou, associate professor in Investigational Cancer Therapeutics.

“If the results of IMPACT1 are confirmed, cancer treatment will be transformed,” she said. “And comprehensive molecular profiling will become the standard of care.”

Foundation Medicine will provide support with their genomic profiling assay, FoundationOne, which detects all classes of genomic alterations in solid tumors across 315 cancer-related genes, as well as 28 other genes often rearranged in cancer.

Information derived from tumor profiling will be available three weeks from the start of enrollment to guide treatment decisions. Physicians and researchers will be able to select eligible patients who may benefit and contribute to all aspects of the study.

“This trial, and others like it, are helping to drive the oncology field forward at a pace never seen before, supporting the evaluation and development of targeted therapies,” said Michael J. Pellini, M.D., president and CEO of Foundation Medicine. “It will ultimately help to provide safer and more effective treatments for all patients with cancer.”