Tumor Profiling Studies on Difficult-to-Treat Gastrointestinal Cancers Aid in Development of Personalized Treatment Planning

-- Research uncovers clinically actionable biomarker targets and key treatment insights for colorectal, gastric, neuroendocrine and appendiceal cancer patients

IRVING, Texas, Jan. 16, 2014 /PRNewswire/ -- Caris Life Sciences®, a leading biosciences company focused on fulfilling the promise of personalized medicine, will present multiple tumor profiling studies at the 2014 Gastrointestinal Cancers Symposium held this week in San Francisco, Calif. This research demonstrates the impact of Caris Molecular Intelligence,™ the company's comprehensive tumor profiling service, on improving care for patients with difficult-to-treat and/or rare and aggressive tumor types, including colorectal, gastric, neuroendocrine and appendiceal cancers. These studies also highlight the importance of the company's unique multi-technology approach to tumor profiling, which identifies clinically relevant alterations beyond DNA sequencing alone.

"In rare tumor types, access to molecularly-guided therapies is imperative, as these patients have fewer standard treatments available to them," said Zoran Gatalica, M.D., DSc, Executive Medical Director at Caris Life Sciences. "In our study of neuroendocrine cancer, we found clinically relevant drug targets in 90 percent of patients profiled, and our study of appendiceal cancer may point the way to a new paradigm in how therapies are prescribed for this disease. These are clear indications of the critical role tumor profiling plays in expanding therapeutic options for these patients."

The company's neuroendocrine cancer study profiled tumors in collaboration with Fox Chase Cancer Center. The study describes two examples where patients experienced extraordinary responses to Caris-directed treatments, highlighting the power of personalized medicine in the treatment of rare and aggressive cancers. Alterations in the expression of three proteins and one somatic mutation were used to identify the effective treatment in the first patient, while the treatment for the second patient was identified through an alteration of expression of just one protein not generally measured in this type of cancer.

The second Caris study profiled appendiceal cancer and was completed in collaboration with Translational Genomics Research Institute - Virginia G Piper Cancer Center. This is the first report of a near universal alteration in appendiceal cancer of a protein associated with approved therapies in other indications. These findings suggest appendiceal cancer patients may benefit from neo-adjuvant treatment with drugs commonly used to treat other cancer types. This study demonstrates how comprehensive profiling can provide great clinical value by illuminating potentially beneficial treatment options in a disease without any randomized clinical trials providing established standard-of-care guidelines.

The third Caris study, in collaboration with Comprehensive Cancer Centers of Nevada, focused on colorectal cancer, examining alterations in the EGFR signaling pathway. This study found that only approximately 20 percent of KRAS wild type patients did not harbor an aberration in the EGFR signaling pathway, potentially explaining why 80 percent of KRAS wild type patients do not respond to EGFR- targeted therapies.

Additionally, the Division of Surgical Oncology, Medical College of Wisconsin, is presenting a fourth poster describing an independent validation of the clinical utility of Caris Molecular Intelligence in gastric cancer. This study will report that approximately 93 percent of gastric cancer patients profiled had alternations in one of three proteins correlated with sensitivity to at least one chemotherapy agent.

A schedule of presentations is as follows:

Friday, Jan. 17, 2014
Poster Presentations

• Abstract 214: Igor A. Astsaturov, Steven J. Cohen, Paul F. Engstrom, et al. Profiling of a global cohort of 1,250 neuroendocrine tumors to identify multiple potential drug targets. BRD: A43, Session B.
• Abstract 131: John T. Miura, Thejus Jayakrishnan, Dan Eastwood, et al. Molecular profiling in gastric cancer: Examining potential targets for chemotherapy. BRD: D37, Session B

Saturday, Jan. 18, 2014
Poster Presentations

• Abstract 399: Gargi D. Basu, Joanne Xiu, David Arguello, et al. Prevalence of KRAS, BRAF, NRAS, PIK3CA and PTEN alterations in colorectal cancer: Analysis of a large international cohort of 5,900 patients . BRD: A18, Session C
• Abstract 469: Erkut Borazanci, Jeffery Kimbrough, Jasgit C. Sachdev, et al. Potential actionable targets in appendiceal cancer detected by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) and mutational analysis. BRD: B32, Session C

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.