The University of Texas MD Anderson Cancer Center announced today an alliance with Cambridge, MA-based Foundation Medicine. The teams are opening a randomized-controlled trial to determine whether targeted therapies selected based on tumor molecular profiling compared with treatment not selected on this basis results in longer progression-free survival in patients with advanced disease.
This study aims to demonstrate that targeted therapies matched to individual patients can improve outcomes. This would support the broader use of this therapeutic strategy across all types of cancers, not just in select ones for whom existing diagnostic and treatment options were insufficient.
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.
That previous study found that of the 1,144 patients enrolled, 40 percent had an identifiable genomic alteration. This early data enabled numerous cancer centers and practicing oncologists to begin using this approach as standard practice to benefit select groups of metastatic patients for whom targeted therapies were medically necessary.
By matching specific gene alterations to therapies, 27 percent of patients responded, compared to 5 percent with an unmatched treatment, and progression-free survival was appreciably longer in the matched group.
Led by Apostolia Maria Tsimberidou, M.D., Ph.D., the IMPACT2 study is an effort to further validate the earlier findings and results of non-randomized studies while engaging industry leaders in genomic profiling. Recognized as precision medicine, MD Anderson physician-scientists believe the approach will lend itself to better patient outcomes. It will also help match patients for clinical trials of new medications, as well as reduce the cost and time necessary to conduct those trials.
"This is a collaborative and institutional-wide effort to improve patient care and accelerate the drug development process," Tsimberidou said. "If the results of IMPACT1 are confirmed, cancer treatment will be transformed and comprehensive molecular profiling will become the standard of care."
The trial is made possible through collaboration with Foundation Medicine, which will provide support with their validated, comprehensive 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. It's expected that more patients will be eligible for targeted therapies given the more comprehensive nature of FoundationOne® versus the molecular testing used in IMPACT1.
"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," said Vincent Miller, M.D., chief medical officer of Foundation Medicine. "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."
The effort brings together MD Anderson's capabilities from several departments, including Investigational Cancer Therapeutics, Thoracic/Head and Neck Medical Oncology, Genitourinary Medical Oncology, Melanoma Medical Oncology, Sarcoma Medical Oncology, Gynecologic Oncology, and Endocrine Neoplasia and Hormonal Disorders; and from several divisions, including Diagnostic Imaging, Pathology, Surgical Oncology, and Biostatistics. Physicians and researchers will be able to select eligible patients who may benefit and contribute to all aspects of the study.
Information derived from tumor profiling will be available three weeks from the start of enrollment to guide treatment decisions.
"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," said 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."
"Through this effort we're partnering with a leader in genomic testing and analysis to further demonstrate how tumor profiling has the potential to improve therapies and reduce development costs," said Ferran Prat, Ph.D., J.D. and vice president of MD Anderson's Strategic Industry Ventures.