New Clinical Data Demonstrate Clinical Utility of Caris Molecular Intelligence Profiling to Aid Treatment Selection for Rare or Refractory Solid Tumors

IRVING, Tex., Sept. 28, 2015 – Caris Life Sciences®, a leading biotechnology company focused on fulfilling the promise of precision medicine, today announces the presentation of new data from clinical research institutions in France and Lebanon that support the clinical utility and value of Caris Molecular Intelligence®, the company’s panomic comprehensive tumor profiling service, in facilitating treatment selection in patients with rare or refractory solid tumors. Results from the two studies were presented during poster sessions at the 2015 European Cancer Congress (ECC2015) in Vienna, Austria.

“Outcomes from these studies are further evidence that Caris’ multiplatform profiling service is informing selection of personalized treatment strategies for patients with various tumor types, including those that are difficult to treat,” said Sandeep K. Reddy, M.D., Chief Medical Officer at Caris Life Sciences. “Such advances are not limited to clinics in North America, but have practical implications for cancer patients around the world, as exemplified by these poster presentations at ECC2015.”

French Study (abstract #414)
In a poster presented on Saturday, September 26, 2015, a team of researchers led by Marc Bollet, M.D., Ph.D., of the American Hospital of Paris, France, reported on their use of Caris Molecular Intelligence in a retrospective, multi-center, observational study of biopsy samples from 74 patients with refractory or progressing metastatic solid tumors. Using Caris’ molecular profiling techniques such as genetic sequencing (Sanger, Next-Generation [NGS] or Pyro Sequencing), protein expression analysis via Immunohistochemistry (IHC), gene amplification via Chromogenic or Fluorescence in situ Hybridization (CISH or FISH), and/or RNA Fragment Analysis, the investigators identified a median of 10 treatments in five drug classes that were associated with potential benefit, and 14 treatments associated with potential lack of benefit. Eighty percent of treatments associated with potential benefit were cytotoxic chemotherapies that were readily accessible.

The investigators reported exceptional outcomes in a number of patients using treatments that would not otherwise be considered. Three patients with refractory cancers received off-label trastuzumab based on HER2 overexpression being found in cancers where it is not commonly tested.

“To our knowledge, this is the first demonstration of the feasibility and application of multiplatform molecular profiling in France,” noted Dr. Bollet. “Our results show that such broad tumor profiling can be implemented in routine clinical practice and is a tool that can aid physicians in the selection of treatment in difficult cases, such as in patients with rare cancers or in individuals who do not respond to standard-of-care therapies.”

Lebanese Study (abstract #251)
In a poster presented today, researchers at Saint Joseph University in Beirut, Lebanon, reported results of a retrospective, single-center, observational study from 103 patients whose refractory or progressing metastatic solid tumors were profiled to guide treatment choice. Using the same multiplatform profiling techniques as in the French study, the investigators identified 81 patients who met the study’s inclusion criteria, 64 of whom were treated according to Caris Molecular Intelligence treatment algorithms. Breast cancer was the most represented malignancy, comprising 21% of cases.

Caris Molecular Intelligence identified a therapy based on a companion diagnostic biomarker in 25 patients; the treatment algorithm suggested hormone therapy in more than two-thirds of these cases. In terms of outcomes, therapy was effective in controlling cancer in 68% of the 64 treated patients, with complete responses reported in four patients (6.3%) and partial responses in 12 patients (18.8%). The average duration of response was 4.3 months.

“Broad multiplatform profiling is a valuable clinical tool that is on its way to becoming a key player in daily practice,” commented lead investigator Abir Ahmadie, M.D., of the Hematology-Oncology Department at Saint Joseph University in Beirut. “Its use offers significant orientation in the choice of therapeutic opportunities for patients with metastatic, refractory, or progressing solid tumors with good performance status. These promising results are the first step toward understanding the practical applications of molecular profiling in terms of tumor response.”

About Caris Life Sciences®
Caris Life Sciences® is a leading biotechnology company focused on fulfilling the promise of precision medicine through quality and innovation. Caris Molecular Intelligence®, the company’s healthcare information and comprehensive tumor profiling service with more than 75,000 patients profiled, provides oncologists with the most clinically actionable treatment options available to personalize cancer care today. Using a variety of advanced profiling technologies to assess relevant biological changes in each patient’s tumor, Caris Molecular Intelligence connects biomarker data generated from a tumor with biomarker-drug associations supported by evidence in the relevant clinical literature. Since 2009, Caris Life Sciences has tracked clinical and outcome data for certain patients undergoing tumor profiling, and has observed that patients treated with drugs consistent with their tumor profile show a significant increase in overall survival.  The company is also developing its ADAPT Biotargeting System™, a revolutionary and unbiased profiling platform with applications across therapy development, drug delivery, advanced diagnostics and disease monitoring. Currently being developed for cancer and other complex diseases, the ADAPT Biotargeting System is able to simultaneously measure millions of molecular interactions within complex biological systems in their natural state(s). 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.  

Media Inquiries:
Caris Life Sciences Media Relations & Corporate Affairs
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David Patti
JFK Communications
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609-241-7365

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