Caris Molecular Intelligence™ Identifies Therapeutic Options, Including Novel Immunotherapeutics, for Patients with Rare, Advanced Anal Squamous Cell Carcinoma

Research Presented at 2015 Gastrointestinal Cancers Symposium Highlights Clinical Utility of Caris Molecular Intelligence

Irving, TX, Jan. 16, 2015 – Caris Life Sciences® today announced the presentation of data from a study in which Caris Molecular Intelligence™, the company’s panomic, comprehensive tumor profiling service, identified potentially actionable alterations in patients with recurring or metastasized anal squamous cell carcinoma (ASCC), a rare human papilloma virus (HPV)-associated malignancy accounting for 2.4% of digestive system cancers. The data, presented at the 2015 Gastrointestinal Cancers Symposium in San Francisco, Calif., point toward potential therapeutic options beyond standard-of-care immunomodulatory agents and pan-HER inhibitors for patients with advanced ASCC, based on the molecular characterization of individual patients’ tumors.

In the study, investigators conducted biomarker analysis of 206 ASCC specimens using Caris Molecular Intelligence’s multiplatform approach, which consisted of gene sequencing (Sanger or next-generation sequencing [NGS]), protein expression analysis (immunohistochemistry [IHC]), and gene amplification (chromogenic or fluorescence in situ hybridization [CISH or FISH]). Although the researchers identified a low incidence of gene mutations, the analysis revealed actionable targets that may help oncologists tailor treatment for patients with ASCC who do not respond to standard therapy.

“While most ASCC malignancies are detected in the early stages and managed effectively, there is little therapeutic guidance for rare, advanced cases, for which cisplatin and 5-fluorouracil comprise the only endorsed regimen,” commented Patrick McKay Boland, assistant professor of oncology at Roswell Park Cancer Institute. “The molecular alterations observed in this study may provide guidance to physicians treating ASCC patients who are experiencing recurrent disease or metastases. For those patients, potential treatment options may extend beyond the standard of care, and may include agents such as topoisomerase inhibitors and taxanes, which are not routinely considered, as well as newer immunotherapeutics such as programmed cell death 1 (PD-1) inhibitors, depending on the level of PD-1 expression within a tumor.”

Study Highlights
Protein analysis and sequencing identified potential treatment options not routinely considered in patients with advanced ASCC. Specifically, NGS revealed mutations in the PIK3CA (33%), FBXW7 (14%), and AKT1 (2%) genes, and IHC detected loss of the PTEN protein in 54% of samples, suggesting that agents targeting the PI3-kinase pathway may be useful in tumors harboring these mutations. IHC also identified PD-1 expression in 42% of samples, indicating the potential for immunomodulatory agents as a therapeutic option. Additionally, ISH uncovered amplification and/or overexpression of epidermal growth factor receptor (EGFR, 7%) and human epidermal growth factor receptor 2 (HER2, 2%), suggesting that targeting receptors of the ErbB family of proteins with anti-EGFR agents or newer-generation pan-HER inhibitors may represent another viable option. Mutations were found in only 17 of the 47 genes tested.

“This study’s identification of actionable biomarkers and novel treatment options in ASCC encourages widespread use of multiplatform molecular profiling in rare and advanced cancers,” stated Sandeep K. Reddy, M.D., chief medical officer of Caris Life Sciences, and a co-investigator in the study. “Our results further validate the clinical utility of Caris Molecular Intelligence in guiding therapeutic decision-making where there is little to no guidance.”

About Caris Life Sciences® and Caris Molecular Intelligence™
Caris Life Sciences® is a leading biosciences company focused on fulfilling the promise of precision medicine through quality and innovation. Caris Molecular Intelligence™, the industry’s leading tumor profiling service with more than 68,000 patients profiled, provides oncologists with the most potentially 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 correlates biomarker data generated from a tumor with biomarker-drug associations supported by evidence in the relevant clinical literature. The company is also developing a series of tests based on its proprietary Carisome® TOP™ 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 Europe, the U.S., Australia and other international markets. To learn more, please visit www.CarisLifeSciences.com.

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