IRVING, Texas, August 28, 2018 – Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced that the company has been selected by the Hoosier Cancer Research Network and the study’s sponsor investigator, Dr. Matthew Galsky, to perform genomic tumor profiling for a new Phase II bladder cancer clinical trial, HCRN GU16-257. This marks the second tumor profiling study Caris has been selected to lead within the Hoosier Cancer Research Network.
The study, “Neoadjuvant Gemcitabine, Cisplatin, Plus Nivolumab in Patients with Muscle-invasive Bladder Cancer with Selective Bladder Sparing,” is seeking to define the safety and activity of multi-combination therapy of gemcitabine, cisplatin, plus the immuno-therapy nivolumab (Opdivo®) as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response in predicting benefit in patients opting to avoid cystectomy. Bladder cancer is the sixth most commonly diagnosed cancer in the U.S., with more than 79,000 new cases and 16,800 deaths estimated in 2017.1
The current standard of care for patients with muscle invasive bladder cancer is a radical cystectomy, or removal of the bladder, which carries with it non-desirable side effects and long-term impact on quality of life. The HCRN GU16-257 trial seeks to determine if the combination of chemotherapy and immunotherapy could be a substitute for this type of surgery for patients carrying certain mutations in DNA repair genes such as ATM, RB1, FANCC, and ERCC2.
Caris will identify and report molecular aberrations via Next-Generation Sequencing of 592 DNA genes and genomic signatures, which include Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI). Caris will also extract tumor DNA and RNA for future study to help determine which biomarkers in the tumor best correlate with patient response in the trial.
“Molecular information has become increasingly critical for identifying the right therapies for the right patients. Identifying cancer’s underlying molecular landscape in trials like these is essential to better understand the biology of cancer and to develop better treatment approaches to fight bladder cancer,” said Matthew Galsky, M.D., of The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai and sponsor-investigator of the study. “Caris’ genomic and clinical reporting capabilities align closely with our trial objectives looking at specific genetic mutations.”
HCRN GU16-257 is open to patient enrollment at The Tisch Cancer Institute at Mount Sinai in New York City, NY.
About Caris Life Sciences®
Caris Life Sciences® is a leading innovator in molecular science focused on fulfilling the promise of precision medicine through quality and innovation, and the world’s leading immunotherapy diagnostic expert. Caris Molecular Intelligence®, the company’s Comprehensive Genomic Profiling Plus (CGP+) molecular testing service, assesses DNA, RNA and proteins, including microsatellite instability (MSI), tumor mutational burden (TMB) and PD-L1, to reveal a molecular blueprint to guide more precise and personalized treatment decisions. Caris’ profiling services are routinely covered by third-party payors, including CMS for Medicare patients. The ADAPT Biotargeting System™, the company’s revolutionary and unbiased profiling platform, is currently being utilized for drug target identification, therapeutic discovery and development, fixed tissue-based companion diagnostics, blood-based cancer screening and biomarker identification. Headquartered in Irving, Texas, Caris Life Sciences offers services throughout the U.S., Europe, Asia and other international markets. To learn more, please visit www.CarisLifeSciences.com.
About Hoosier Cancer Research Network
Hoosier Cancer Research Network, Inc., formerly known as Hoosier Oncology Group, conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has conducted more than 170 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 7,500 subjects have participated in Hoosier Cancer Research Network clinical trials. To learn more, visit www.hoosiercancer.org.
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1. American Cancer Society. Cancer Facts & Figures 2017. www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf