Clinical Validity of Molecular Profiling from Caris Life Sciences Confirmed by Study Demonstrating Increased Median Overall Survival and Clinical Impact on Treatment Decisions

Prospective, Observational Profiling Data Presented at ECC 2015 Highlight a Significant 422-Day Increase in Overall Survival, Clinical Impact on Physician Treatment Selection in 53% of Cases 

When Expanded to Include Treatments Given Prior to Profiling, Data Revealed an Increase in Median Survival of 1.1 years

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 data from a six-year prospective, observational study in which Caris Molecular Intelligence®, the company’s panomic comprehensive tumor profiling service, was associated with a median increase in overall survival of 422 days in 1,180 patients with solid tumors. The study results, presented at the 2015 European Cancer Congress (ECC) in Vienna, Austria, also suggest that such profiling can be used to facilitate therapeutic decision-making, based on a demonstrated clinical impact on physicians’ treatment decisions in 53% of cases.

“Our research substantiates that Caris’ multiplatform molecular profiling approach has a significant ability to detect a better prognostic group for overall survival in patients with refractory, metastatic or rare cancers for which there is no standard of care, based on the molecular drivers of an individual’s cancer,” said lead investigator David Spetzler, Ph.D., Chief Scientific Officer at Caris Life Sciences. “Moreover, when patients receive effective drugs, they are exposed to fewer overall agents, thereby potentially reducing the toxicity as well as the costs of anticancer treatment.”

Dr. Spetzler and colleagues used Caris Molecular Intelligence to analyze profiling data from 1,180 patients (including 465 deaths) spanning more than 40 lineages.  The patients were categorized into two observational arms. Patients that received one or more drugs identified to be of benefit and no drugs identified to be of lack-of-benefit were placed into the “Matched” (M) arm, i.e. their treatment matched their profile recommendations. Patients receiving at least one drug predicted to be of lack of-benefit were placed into the “Unmatched” (U) group. Classification of patients into each arm was made for drugs administered both before (n=1180) and after tumor profiling (n=1027) with no detectable bias from age, race or stage (170 patients received no therapies after undergoing profiling).

Survival analysis of the M group (n=534) compared to the U group (n=493) showed a significant increase in overall survival (p = 0.01, hazard ratio [HR] = 0.68), and a median increase in overall survival of 422 days (1068 vs. 648 days). Patients in the M group received 3.2 therapies compared to 4.2 therapies administered to those in the U group. When the groups were expanded to include treatments given prior to profiling, there was an increase in overall survival (p = 0.0003, HR = 0.714), with an increase in median survival of 1.1 years (978 vs. 580). Upon post-profiling follow-up, physicians indicated that Caris’ molecular profiling influenced their therapeutic decision-making for 629 of the 1,180 (53%) patients. Of those 629 patients, 97% (611) received a drug recommended in the benefit category and 46% (292) did not receive any lack-of-benefit category drugs.

“These data underscore the clinical validity of Caris Molecular Intelligence and reinforce its value as an effective prognostic tool to help guide treatment decisions – decisions that played a significant role in increasing overall survival in a majority of patients,” said Sandeep K. Reddy, M.D., Chief Medical Officer at Caris Life Sciences. “We are inspired by these results and will continue to provide physicians with the most comprehensive molecular profiling service to improve understanding of oncologic biomarkers in individual patients.”

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
CorpComm@carisls.com

David Patti
JFK Communications
dpatti@jfkhealth.com
609-456-0822

Download PDF Version - Clinical Validity of Molecular Profiling from Caris Life Sciences Confirmed by Study Demonstrating Increased Median Overall Survival and Clinical Impact on Treatment Decisions