Caris Life Sciences, National Cancer Institute and ECOG-ACRIN Collaborate to Molecularly Identify Candidates for the NCI-MATCH Clinical Trial

Caris to Participate in Next-Generation Sequencing Concordance
Evaluation with NCI-MATCH Trial Laboratory Network

IRVING, Texas, June 7, 2017 Caris Life Sciences®, a leading innovator in molecular science, today announced a collaboration with the National Cancer Institute (NCI) for the NCI-Molecular Analysis for Therapy Choice (NCI-MATCH or EAY131) precision medicine trial, which is being implemented by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN). Under the terms of the collaboration, Caris will notify physicians from more than 1,100 clinical sites participating in NCI-MATCH when the Caris Molecular Intelligence® assay, the company’s Comprehensive Genomic Profiling Plus (CGP+) molecular testing service, identifies gene abnormalities that could make a patient eligible for one of several NCI-MATCH treatments. Caris will provide clinical trial outreach services, called MI Trials, to inform the treating oncologist that their patient may be eligible for one of several NCI-MATCH treatments. Additionally, Caris will participate in a concordance analysis to evaluate next-generation sequencing results for identified trial patients with ECOG-ACRIN and NCI laboratories.

“NCI-MATCH is an incredibly important trial, as the results of this signal-finding study may significantly impact the design of larger, more definitive precision medicine-based clinical trials,” said John Marshall, M.D., Chief Medical Officer of Caris Life Sciences, Associate Director for Clinical Care for the Georgetown Lombardi Comprehensive Cancer Center and the Chief of the Division of Hematology-Oncology at MedStar Georgetown University Hospital in Washington, D.C. “We look forward to collaborating with both ECOG-ACRIN and the NCI and believe Caris’ tumor profiling capabilities and MI Trials services are well-suited to identify eligible patients to help the trial meet its goals.”

This month, the NCI-MATCH trial is expected to reach its goal to sequence the tumors of 6,000 patients, nearly two years early due to rapid patient enrollment. However, an important discovery in the patients tested to date shows that every tumor gene abnormality being studied is less common than expected in this study population, ranging from 3.47 percent to zero. This finding is shedding new light on the fact that for several of the treatment arms to reach their 35-patient goal, the trial needs to cast a wider net and look at tens of thousands of patients.

Caris Molecular Intelligence, which has performed more than 117,000 clinical cases to date, helps physicians and researchers more effectively evaluate therapy options and clinical trial opportunities to enable the delivery of precision medicine. When a treating oncologist at a participating NCI-MATCH site orders tumor profiling to guide clinical care for their patients, Caris will look for trial matches for these patients. Upon the identification of a qualifying genetic alteration abnormality (such as mutations, amplifications or translocations), Caris will include NCI-MATCH trial information in the patient’s broader report as a potential treatment option.

In addition, MI Trials medical staff will inform the treating physician about the NCI-MATCH trial and, when determined appropriate, will facilitate communication between the treating physician and NCI-MATCH study investigators.

“Tumor profiling and genomic testing are becoming common in daily practice for oncologists to help guide clinical care for cancer patients,” said ECOG-ACRIN study co-chair Peter J. O’Dwyer, M.D., University of Pennsylvania. “We are excited about Caris Life Sciences’ involvement with the NCI-MATCH trial and we look forward to working together to proactively identify potentially eligible patients to fill several arms of the trial.”

NCI-MATCH (EAY131 or NCT02465060) is a phase II precision medicine trial that seeks to determine the effectiveness of treatment that is directed by genomic profiling in patients with solid tumors, lymphomas, or myelomas that have progressed following all standard treatments expected to prolong survival or rare cancer types for which there is no standard treatment. Such discoveries could be eligible to move on to larger, more definitive trials. With multiple treatment arms addressing a wide range of tumor types and targeted treatments, NCI-MATCH is one of the largest precision medicine cancer trials to date. To learn more about the study, including clinical trial sites across the country, visit www.ecog-acrin.org/nci-match-eay131 and www.clinicaltrials.gov/show/NCT02465060 or see the announcement at www.ecog-acrin.org/news-and-info/press-releases/nci-match-eay131-casts-a-wider-net.

Caris will also participate with ECOG-ACRIN and NCI in a concordance evaluation of the next-generation sequencing results for identified patients. The sequencing results generated from Caris will be compared to the results from the NCI-MATCH trial’s laboratories. Consistent, accurate data detecting and reporting genomic alterations across various academic and commercial laboratories has important implications for patient care as the demand for genomic information continues to increase.

“It is paramount that laboratories across the country are providing accurate and reliable results because they have direct impact on the care provided to cancer patients,” said Dr. Marshall. “We look forward to working with ECOG-ACRIN and the NCI to evaluate the data and continue to improve precision medicine.”

About Caris Life Sciences®
Caris Life Sciences® is a leading innovator in molecular science focused on fulfilling the promise of precision medicine through quality and innovation. Caris Molecular Intelligence®, the company’s Comprehensive Genomic Profiling Plus (CGP+) molecular testing service and the world’s leading immunotherapy diagnostic expert, assesses DNA, RNA and proteins, including microsatellite instability (MSI), total mutational load (TML) and PD-L1, to reveal a molecular blueprint to guide more precise and personalized treatment decisions.  The ADAPT Biotargeting System, the company’s revolutionary and unbiased profiling platform, is currently being utilized for drug target identification, therapeutic discovery and development, fixed tissue-based companion diagnostics, blood-based cancer screening and biomarker identification. Headquartered in Irving, Texas, Caris Life Sciences offers services throughout the U.S., Europe and other international markets. To learn more, please visit www.CarisLifeSciences.com.

About the ECOG-ACRIN Cancer Research Group
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) co-designed NCI-MATCH with the NCI and is leading the trial, a role that involves coordinating the genomic testing and supporting nearly 1,100 cancer centers and community hospitals that are participating in the trial with training, laboratory services, trial assignments, biostatistical support, data management, auditing, quality control, and public awareness. ECOG-ACRIN is a membership-based scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer. It is headquartered in Philadelphia, Pa. For more information, visit www.ecog-acrin.org, follow @eaonc on Twitter, or call 215.789.3631.

Media Inquiries:
The Ruth Group
Kirsten Thomas / Joanna Zimmerman
kthomas@theruthgroup.com / jzimmerman@theruthgroup.com
Tel: +1-508-280-6592 / +1-646-536-7006

Caris Life Sciences Media Relations
CorpComm@carisls.com
214-294-5606

ECOG-ACRIN Cancer Research Group Media Relations
communications@ecog-acrin.org
215-789-3631

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