Hoping for a significant IMPACT

HOUSTON—The University of Texas MD Anderson Cancer Center and Foundation Medicine have joined forces to launch a randomized-controlled trial to evaluate which treatment method will results in longer progression-free survival in patients with advanced disease: targeted therapies chosen based on tumor molecular profiling or treatment not selected on that basis. The study, known as the IMPACT2 (Initiative for Molecular Profiling and Advanced Cancer Therapy) trial, will seek to show that targeted therapies offer improved outcomes, and will be led by Dr. Apostolia Maria Tsimberidou of MD Anderson.

“This is a collaborative and institutional-wide effort to improve patient care and accelerate the drug development process,” Tsimberidou said in a press release. “If the results of IMPACT1 are confirmed, cancer treatment will be transformed and comprehensive molecular profiling will become the standard of care.”

This initiative follows the first IMPACT trial, which presented its results in 2011 at the annual meeting of the American Society of Clinical Oncology. In IMPACT, 40 percent of the 1,144 enrolled patients presented with an identifiable genomic alteration. When specific gene alterations were matched with appropriate therapies, 27 percent of patients responded, compared to 5 percent with an unmatched treatment. In addition, progression-free survival was noticeably longer in the matched group.

“Based on the IMPACT1 data, a validated, comprehensive profiling approach has already been adopted by many academic and community-based oncology practices. They use this approach for select groups of cancer patients for whom existing diagnostic and treatment options are inadequate, such as non-small cell lung cancer, cancer of unknown primary and rare tumors,” Dr. Vincent Miller, chief medical officer of Foundation Medicine, commented in a statement. “This study has the potential to yield sufficient evidence necessary to support broader adoption across most newly diagnosed metastatic tumors. We’re pleased to partner with MD Anderson, who is uniquely positioned to execute this study given their clinical trials expertise.”

For this work, Foundation Medicine will offer the use of FoundationOne, their validated, comprehensive genomic profiling assay that can detect all classes of genomic alterations in solid tumors across 315 cancer-related genes, in addition to 28 other genes that are often rearranged in cancer.

“We’re pleased to collaborate with Dr. Tsimberidou and MD Anderson on this important clinical trial that’s bringing the benefits of FoundationOne to patients with cancer,” added Michael J. Pellini, M.D., president and CEO of Foundation Medicine. “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. It will ultimately help to provide safer and more effective treatments for all patients with cancer.”

SOURCE: MD Anderson press release