Multi-Platform Tumor Profiling Research in Bladder and Prostate Cancers Yields Expanded Therapeutic Options for Patients

-- International studies demonstrate importance of  comprehensive tumor profiling for poor-prognosis cancer patients

IRVING, Texas, Jan. 30, 2014 /PRNewswire/ -- Caris Life Sciences®, a leading biosciences company focused on fulfilling the promise of personalized medicine, will present two tumor profiling studies at the 2014 Genitourinary Cancers Symposium held this week in San Francisco, Calif. Through use of the company's comprehensive tumor profiling service, Caris Molecular Intelligence, these bladder and prostate cancer studies demonstrate the importance of a multi-technology approach to profiling poor-prognosis cancer patients. Both studies relied upon fluorescent in situ hybridization (FISH), immunohistochemistry (IHC) and other traditional pathology techniques in combination with DNA and mRNA analysis to identify actionable clinical insights. A schedule of presentation is as follows:

Thursday, Jan. 30, 2014

• Abstract 107: Rebecca Feldman, Gargi Basu, Joanne Xiu, et al. Molecular Profiling of Advanced Refractory Prostate Cancer. BRD C6. Presented by Charles Myers, M.D. from American Institute for Diseases of the Prostate

Friday, Jan. 31, 2014

• Abstract 311: Sherri Z. Millis, David Bryant, Gargi Basu, et al. Molecular Profiling of Infiltrating Urothelial Carcinoma of the Bladder. BRD: C17. Presented by Nick Vogelzang, M.D. from Comprehensive Cancer Centers of Nevada

In collaboration with the American Institute for Diseases of the Prostate, Caris' study analyzed an international patient cohort to better define prostate cancer's molecular profile as well as uncover new, potentially effective therapy combinations for advanced refractory patients. This research found some patients may respond to new combinations of traditional chemotherapy paired with targeted agents identified through biomarker analysis. This includes therapies approved for other cancer types (imatinib, cetuximab), promising drugs currently in clinical trials (cabozantinib) or agents not routinely prescribed for prostate cancer (gemcitabine). Of the advanced prostate cancer tumors studied, 98.5 percent found actionable alterations associated with FDA-approved treatment options. IHC and in situ hybridization (ISH) accounted for 97 percent, while DNA sequencing found mutations in 34 percent. These data points highlight the critical importance of a multi-platform approach to tumor profiling.

"By combining IHC/ISH biomarker results with mutational analysis, we identified patient subgroups that may benefit from combining traditional chemotherapies and hormonal agents with novel targeted agents," said Charles Myers, M.D., Director, American Institute for Diseases of the Prostate. "For example, a great majority of prostate cancer patients exhibit high expression of androgen receptor, and are typically treated with anti-androgen therapies. However, 24 percent of patients studied were found to have PTEN expression loss and PTEN/PIK3CA mutations. This demonstrates these patients may likely benefit from a combination treatment strategy of an anti-androgen therapy with a targeted agent like everolimus, which are currently available in clinical trials."

Caris' second tumor profiling study, in collaboration with Comprehensive Cancer Centers of Nevada, investigated a large international cohort of metastatic urothelial carcinoma, with patients profiled from all 50 states and approximately 40 other countries. Using multiple technologies, including FISH, CISH, IHC, DNA mutational analysis and RNA fragment analysis, this study of the most common variant of urinary bladder cancer identified biomarker targets not routinely associated with urothelial carcinoma. Study results indicate that these biomarker targets may lead to personalized therapy for patients, using both recommended standard treatments, as well as therapies approved for other tumor types (but not currently approved for urothelial carcinoma). The study also found that, while EGFR and HER2 mutations were individually uncommon, the identification of such targets in a patient with urothelial carcinoma opens additional clinical trial opportunities.

"For patients with metastatic urothelial carcinoma, the identification of additional treatment options through comprehensive tumor profiling is critically important, as no significant major drug advances have been made in this form of bladder cancer during the last 20 years," said Nicholas J. Vogelzang, M.D., U.S. Oncology Research and Comprehensive Cancer Centers of Nevada. "Currently, there are six NCCN-recommended therapies in the standard treatment guidelines for these patients. This biomarker analysis points toward an additional 20 drugs that could be considered for these patients."

About Caris Molecular Intelligence™

Caris Molecular Intelligence™ has been the leading cancer profiling service on the market since 2006, having been used for more than 60,000 cancer patients and counting by more than 6,000 oncologists in at least 59 countries to help develop individualized and actionable treatment plans that seek to improve patient care.  Caris Molecular Intelligence™ utilizes the most comprehensive range of analytical technologies endorsed by the latest and most robust evidence — immunohistochemistries, fluorescence and chromogenic in situ hybridization, polymerase chain reaction and Next-Generation sequencing – to provide oncologists the most complete and clinically relevant profile of a patient's unique cancer-related biomarkers. Unlike other commercially available tumor profiling services, Caris Molecular Intelligence™ more completely interrogates a patient's unique tumor biology by going beyond just DNA analysis. Caris' service assesses additional important biological components like RNA and protein expression levels to establish a multi-dimensional profile of a patient's tumor that reveals more fully the complex biological processes that are driving that patient's cancer and, therefore, more, relevant targets for potential clinical action. 

With a multi-dimensional profile of a patient's unique tumor, Caris Molecular Intelligence integrates insights from its proprietary and industry-leading evidence curation and bioinformatics platform to identify and report the most clinically relevant associations to drug therapies that are approved by the U.S. Food & Drug Administration or are in active clinical trials in the U.S. Managed by the Caris Evidence Design Board, a dedicated team of oncology experts that includes 5 Ph.D.s and 6 M.D.s, the Caris Molecular Intelligence evidence and bioinformatics platform curates, classifies and catalogues the findings and evidence from all relevant clinical studies in cancer and cancer biology available in the published scientific and medical literature, using a methodology adapted from the evidence review process of U.S. Preventive Services Task Force (www.uspreventiveservicestaskforce.org) of the Agency for Health Research and Quality (www.ahrq.gov).  This platform incorporates the review of more than 100,000 publications and counting.  Relying on the most robust evidence that meets Caris' quality standards, the Caris Molecular Intelligence evidence and bioinformatics platform can currently provide therapeutic guidance for up to 43 drug associations with Caris' multi-dimensional approach to tumor profiling, far exceeding the 12 that can be identified using next-generation sequencing alone.  The Caris Molecular Intelligence bioinformatics platform electronically delivers the profile and all of these results in an easy-to-use report format that gives oncologists access to underlying evidence, enabling them to develop tailored treatment plans for each unique patient. For more information on Caris Molecular Intelligence™, visit www.carismolecularintelligence.com.

About Caris Life Sciences

Caris Life Sciences is a leading biosciences company focused on fulfilling the promise of personalized medicine.  As the first commercial mover in comprehensive molecular profiling in oncology, Caris Molecular Intelligence™ is an industry vanguard, with 60,000-plus patients profiled and counting. Ordered by nearly 6,000 oncologists in 59 countries, Molecular Intelligence correlates molecular data generated from a patient's tumor with biomarker/drug associations derived from clinical cancer literature. Using a variety of advanced and clinically-relevant technologies, Caris provides oncologists with the most clinically actionable information to help them personalize treatment for cancer patients. This multi-technology approach enables Caris to provide therapeutic guidance for 43 drug associations, compared to the 12 that can be found through use of next-generation sequencing alone. The company is also developing a series of blood tests based on its proprietary Carisome® platform — a revolutionary blood-based testing technology for diagnosis, prognosis, and theranosis of cancer and other complex diseases. Headquartered in Irving, Texas, Caris Life Sciences offers services throughout the U.S., Europe, Australia and other international markets. To learn more, please visit www.carislifesciences.com.