Date: 2016-10-04
Type of information: Initiation of development program
phase:
Announcement: initiation of development program
Company: Pancreatic Cancer Action Network (USA)
Product: Precision Promise
Action mechanism:
Disease: pancreatic cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On October 4, 2016, the Pancreatic Cancer Action Network announces Precision Promise, the first large-scale precision medicine trial designed to transform outcomes for patients with pancreatic cancer. The organization also announces the 12 initial Precision Promise Clinical Trial Consortium sites selected to participate in this groundbreaking initiative. Bringing together the field’s key stakeholders, including clinicians, researchers and diagnostic and drug developers, Precision Promise will put the patient at the center of every decision and will advance the Pancreatic Cancer Action Network’s goal to double survival by 2020. The Pancreatic Cancer Action Network has committed a minimum initial investment of $35 million over the first four years, not including drug costs, and expects to enroll thousands of patients.
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. 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.
Precision Promise will partner with health-tech company, Tempus, to utilize 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, Cancer 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.
In addition to the scientific learnings from collective data, targeted precision medicine grant funding opportunities will also be made available by the Pancreatic Cancer Action Network that will help inform and influence the direction of future therapeutic options through Precision Promise.
The Precision Promise infrastructure is uniquely collaborative and cooperative, led by an executive committee co-chaired by Andrew Biankin, MBBS, PhD, University of Glasgow, and Diane Simeone, MD, University of Michigan, and featuring working groups of leading experts and diagnostic 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.
The 12 initial Clinical Trial Consortium sites participating in Precision Promise were selected through a competitive peer-reviewed process and include Cedars-Sinai (Los Angeles), Dana Farber/Harvard Cancer Center (Boston), Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance/University of Washington (Seattle), Memorial Sloan Kettering Cancer Center (New York), University of California, San Diego (San Diego), University of California, San Francisco (San Francisco), University of Chicago (Chicago), University of Florida (Gainesville, Fla.), University of Michigan (Ann Arbor, Mich.), University of Pennsylvania (Philadelphia), Virginia Mason (Seattle) and Washington University (St Louis).
