ANN ARBOR, Mich. — The University of Michigan Comprehensive Cancer Center is one of 12 sites to join Precision Promise, the first large-scale precision medicine trial designed to transform outcomes for patients with pancreatic cancer. The initiative was announced today by the Pancreatic Cancer Action Network.
Bringing together the field’s key stakeholders, including clinicians, researchers and drug developers, Precision Promise will put the patient at the center of every decision to advance the Pancreatic Cancer Action Network’s goal to double survival by 2020.
“With Precision Promise, we have the opportunity to do something really remarkable to change therapeutic options for patients,” says Diane Simeone, M.D., director of the Pancreatic Cancer Center at the University of Michigan. Simeone served as co-chair of the executive committee that helped create the vision for Precision Promise.
“I have had the privilege to take care of pancreatic cancer patients for many years. This effort has the potential to completely change the landscape for pancreatic cancer. I am so excited to work in this national collaborative effort to push the limits of what we can achieve together on behalf of our patients,” she adds.
Pancreatic cancer is the third-leading cause of cancer related death in the United States and is anticipated to become the second around 2020. The disease kills more people than breast cancer and has a five-year survival of just 8 percent. Nationally, only 4 percent of pancreatic cancer patients enroll in clinical trials.
“Precision Promise will dramatically accelerate the clinical trial process to bring promising therapies to patients faster,” said Julie Fleshman, JD, MBA, president and CEO of the Pancreatic Cancer Action Network. “Precision Promise is an unprecedented opportunity for patients and is vital to move the field forward. Instead of looking for the right patient for a clinical trial, we are designing the right clinical trial for each patient.”
In order to change the pancreatic cancer treatment paradigm, Precision Promise will investigate multiple treatment options, called sub-studies, under one clinical trial design that utilizes an individualized treatment approach based on the molecular profile of a patient and their tumor.
The sub-studies are designed to be nimble and dynamic, so a patient can shift to another option quickly without wasting precious time between clinical trials. The system will constantly evolve the treatment options by integrating current research and the most up-to-date science and knowledge available.
Sub-studies can be added for newly discovered biomarkers and treatment approaches, so the field can learn which patients will most benefit from these new developments, and get new, effective treatments to patients sooner.
Starting in the spring of 2017, participating patients will enroll in Precision Promise at a local Clinical Trial Consortium site, including the University of Michigan. Each patient will undergo advanced molecular profiling to determine their tumor’s unique molecular features, which will inform which Precision Promise sub-study will best match their individual needs. Once on treatment, patients will be monitored closely and follow-up analyses will be conducted to provide important clues to help researchers quickly understand the effectiveness of each treatment in real time.
Currently, important genetic data and clinical trial results are fragmented across various institutions and drug developers, and some important results may never be shared publicly for researchers to learn from these findings.
Through Precision Promise, all data from the initial 12 Clinical Trial Consortium sites will be analyzed together so scientific findings are gathered and disseminated to the research community in a timely manner.
The Precision Promise infrastructure is uniquely collaborative and cooperative, led by the Pancreatic Cancer Action Network and an executive committee co-chaired by Simeone and Andrew Biankin, MBBS, PhD, University of Glasgow, and featuring working groups of leading experts and drug developers, all of whom are providing expertise and guidance. Supporting the effort are initial members of the Industry Working Group, Promise Patrons Halozyme Therapeutics, Merrimack Pharmaceuticals, Tempus and Trovagene, Inc.
Precision Promise will partner with health-tech company Tempus to use their cutting edge genomic sequencing and analysis methods. Tempus collects and analyzes large amounts of genomic data using statistical analysis, machine learning, and proprietary algorithms to help physicians make real-time, data-driven decisions for their patients. Also, Clinical Research And Biostatistics (CRAB) will serve as the Precision Promise Contract Research Organization to provide statistical analyses, data management support as well as clinical monitoring for the trials.