On September 14, 2021 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported that it has entered into a collaboration agreement with the National Surgical Adjuvant Breast and Bowel Project (NSABP), a cooperative group founded by the National Cancer Institute (NCI) (Press release, Exact Sciences, SEP 14, 2021, View Source [SID1234587658]). Working together, Exact Sciences and the NSABP plan to conduct a prospective, multicenter validation study with stage II and III colorectal cancer (CRC) patients, demonstrating the ability of Exact Sciences’ ctDNA test to detect MRD . The study, called CORRECT-MRD II, is expected to enroll approximately 750 patients at 35 study sites in the U.S. and Canada and is part of Exact Sciences’ global initiative to generate clinical validation data for its tumor-informed MRD liquid biopsy test.
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Exact Sciences and NSABP Announce Validation Study to Detect Minimal Residual Disease in Colorectal Cancer Patients
"Our longstanding relationship with the NSABP, through our work to develop and validate the Oncotype DX Breast Recurrence Score and Colon Recurrence Score tests, represents a remarkable collaboration between academic and industry partners. This relationship has fueled major advancements in understanding the role of molecular profiling in breast and colon cancer," said Rick Baehner, MD, chief medical officer of Precision Oncology for Exact Sciences. "NSABP’s expertise in colon research makes them ideal collaborators to conduct this important MRD study in colorectal cancer. We look forward to working together on this tremendous opportunity to help shape the future of precision medicine."
Exact Sciences is well-positioned to bring a highly sensitive MRD solution to patients in need. Its recent exclusive license of the Targeted Digital Sequencing (TARDIS) blood biopsy technology and acquisition of Ashion Analytics help prepare Exact Sciences to develop a differentiated patient-specific solution in MRD testing. With proven evidence-generation abilities and deep commercial relationships, Exact Sciences has the capability to bring its solution to patients and providers in the U.S. quickly and efficiently. In addition, the patient specific MRD test may have the potential to be synergistic with the predictive and prognostic insights provided by the Exact Sciences’ Oncotype portfolio to further inform treatment decisions to help improve patient outcomes. The company aims to explore the full potential of its MRD technology across all solid tumor types.
"The NSABP is committed to designing and conducting clinical trials that improve the treatment of colorectal cancer by evaluating promising new diagnostics and treatments," said Norman
Wolmark, MD, chairman of the NSABP Foundation and of the NCTN group NRG Oncology. "Highly sensitive MRD tests have the potential to fundamentally change the solid tumor treatment and monitoring paradigm. Exact Sciences’ unique approach to MRD and its commitment to improving patient outcomes make them ideal collaborators for advancing this promising new technology."
Exact Sciences and the NSABP are also working with patient advocacy organization Fight Colorectal Cancer (Fight CRC) to help inform MRD study designs and identify potential barriers to study participation, particularly in underserved populations. This joint effort will help ensure patient recruitment and patient-facing study materials are clear and sensitive to diverse cultures and socioeconomic backgrounds.
"Participating in a clinical study or trial is a personal journey and decision that includes many different factors and considerations for each patient," said Anjee Davis, president of Fight CRC. "Collaboration between patients, patient advocates, and clinical study professionals is vital. We’re proud to work with Exact Sciences and the NSABP on this important research, ensuring colorectal cancer patients from all backgrounds are represented and their voices are kept at the forefront."
About Minimal Residual Disease
Minimal residual disease (MRD) refers to the presence of tumor-specific DNA in the body after cancer treatment. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the blood by solid tumors as part of the tumor growth cycle. Their presence may indicate that a tumor is likely to return. Solid tumors are typically undetected until they are advanced enough to be picked up by a medical image or physician examination. The detection of ctDNA at extremely low levels has the potential to provide crucial insights that may help discover cancer recurrence earlier and inform treatment decisions.
About Exact Sciences’ MRD Program
The Exact Sciences’ MRD solution is being designed to utilize a tumor-informed (bespoke) approach with whole genome sequencing. This approach identifies somatic genetic alterations in DNA extracted from the patient’s tumor tissue and detects a subset of these mutations in ctDNA present in the patient’s blood. The MRD test that Exact Sciences is developing is intended for patients diagnosed with solid tumor malignancies to detect ctDNA before, during, and after cancer treatment. Such information may be used for guidance of adjuvant or neoadjuvant therapy decisions and/or for monitoring of recurrence after completion of adjuvant or neoadjuvant therapy, in conjunction with other clinicopathological findings. The company estimates that more than 1.5 million patients1 in the United States alone could benefit from this type of MRD testing.