お知らせ • May 27
Exact Sciences Corp. Presents New Long-Term Patient Outcomes in Multi-Cancer Early Detection and Breast Cancer Recurrence Testing at ASCO 2023
Exact Sciences Corp. announced that it will present 15 abstracts at the American Society of Clinical Oncology® (ASCO®) Annual Meeting 2023, June 2-6, in Chicago, Illinois. Presentations include new data confirming Exact Sciences' approach to multi-cancer early detection (MCED), real-world outcomes using the Oncotype DX Breast Recurrence Score®, and modeling comparisons between Cologuard® and potential blood-based screening tests for colorectal cancer. Long-term analyses from Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing (DETECT-A), the first large, prospective, interventional study to screen for multiple cancers with a blood-based MCED test, showed that all patients diagnosed and treated for Stage I or II cancers remain cancer-free more than four years later. Most detected cancers had no standard of care screening tests. Data also showed that half of all patients with a cancer detected were successfully treated and remain cancer free more than four years after their initial test. Earlier analyses showed that an MCED test more than doubled the number of screening-detected cancers compared to standard-of-care screening methods alone. These new, encouraging, long-term data outcomes in MCED-detected cancer survivors continue to provide important context for the advancements in the Exact Sciences MCED program. In addition, Exact Sciences will present a new, long-term Surveillance, Epidemiology, and End Results (SEER) analysis showing that the Oncotype DX Breast Recurrence Score® test is prognostic for breast cancer-specific mortality (BCSM) in patients with invasive ductal carcinoma (IDC) and invasive lobular breast cancer (ILC). In the 9-year analysis of nearly 10,000 patients with ILC and 65,000 patients with IDC, high Recurrence Score® (RS) results corresponded to high rates of chemotherapy use and BCSM risk. These correlations, which occurred regardless of whether the cancer had spread to lymph nodes, confirm the overall benefit of and confidence in the Oncotype DX Breast Recurrence Score test.3 These results build upon a previous study, confirming a clear and robust link between RS results and 5-year BCSM outcomes for patients with IDC and ILC. The Oncotype DX Breast Recurrence Score test is a prognostic genomic test designed to predict the likelihood of disease recurrence and chemotherapy benefit for patients with early-stage breast cancer, which Exact Sciences clinically validated in the TAILORx and RxPONDER trials. Exact Sciences will also share findings from modeling studies showing the positive impact of colorectal cancer screening with Cologuard® compared to a hypothetical blood-based test meeting CMS minimum performance thresholds. The studies provide insights into the overall lower costs of Cologuard compared to a blood based colorectal cancer blood test, as well as data showing higher life years gained when Cologuard is utilized compared to a potential blood-based test for colorectal cancer. Further data sets detail the results from a study estimating the undiagnosed cancer incidence in the U.S. , and additional studies with OncoExTra™, Oncotype DX Breast Recurrence Score, and Oncotype DX® Colon will also be presented. Data presentations across: Exact Sciences' Screening and Precision Oncology portfolios at ASCO 2023 Multi-Cancer Early Detection: Abstract 3037/Poster Bd #235: Long-term clinical outcomes of cancers diagnosed following detection by a blood-based multi-cancer early detection (MCED) test: Authors: Buchannan A, et al. Date/Time: Saturday, June 3, 8:00 a.m. - 11:00 a.m. CT. Location: Hall A. Key Findings: Half of all patients with an MCED-detected cancer (13/26) were successfully treated and cancer free over four years after their initial MCED test, and over half of the patients in remission (7) had cancers with no standard-of-care screening options available. All patients with Stage I or II cancers who were treated remain cancer-free. Abstract 3039/Poster Bd #237: Outcomes in participants with a false positive multi-cancer early detection (MCED) test: Results from >4 years follow-up from DETECT-A, the first large, prospective, interventional MCED study: Authors: Lennon A, et al. Date/Time: Saturday, June 3, 8:00 a.m. - 11:00 a.m. CT. Location: Hall A. Key Findings: False positive signals from MCED were uncommon, affecting less than 1% of individuals tested. Imaging-based diagnostic evaluation accurately evaluated patients with a false positive and the incidence of cancer following a false-positive MCED test was <1% per year after a median follow-up time of 4.3 years, confirming the capacity of imaging-based work-up to reassure patients. Abstract 3040/Poster Bd #237: The detection of multiple cancer types with an extended set of methylation and protein markers: Authors: Viatcheslav E, et al. Date/Time: Saturday, June 3, 8:00 a.m. - 11:00 a.m. CT. Location: Hall A. Key Findings: Results from this pilot study found high sensitivity levels for cancer detection with methylated DNA and protein markers, demonstrating the potential for developing a sensitive and specific MCED test by combining these markers. At 99% specificity, overall sensitivity for cancer detection with DNA methylation markers (MDM) was 68%. Detection sensitivity with proteins was 43%. The MDMs and proteins model (8 MDMs and 5 proteins) achieved 75% sensitivity at 99% specificity. Precision Oncology: Abstract 554/Poster Bd #384: SEER analysis of 9-year breast cancer specific mortality (BCSM) in patients (pts) with invasive lobular breast cancer (ILC) assessed by the 21-gene Breast Recurrence Score assay: Authors: Geyer C, et al. Date/Time: Saturday, June 3, 8:00 a.m. - 11:00 a.m. CT. Location: Hall A. Key Findings: Oncotype DX Breast Recurrence Score test results were significantly linked to chemotherapy use and BCSM outcomes, confirming the prognostic benefit and overall confidence in these recurrence scores for ILC. Abstract 515/Poster Bd #324: ECOG-ACRIN E2197: Comparison of HER2 gene expression by RT-PCR across all HER2 immunohistochemistry groups with recurrence analysis: Authors: Badve S, et al. Date/Time: Sunday, June 4, 4:30 p.m. - 6:00 p.m. CT. Location: Hall B1. Key Findings: After analyzing a wide range of HER2 gene expression levels using the Oncotype DX® assay in breast cancer patients, HER2 expression was found to be associated with recurrence risk. Abstract 3620/Poster Bd #320: Treatments and clinical outcomes in stage II colon cancer (CC) patients (pts) with 12-gene Oncotype DX Colon Recurrence Score assay-guided therapy: Real-world data: Authors: Brenner B, et al. Date/Time: Monday, June 5, 8:00 a.m. - 11:00 a.m. CT. Location: Hall A. Key Findings: A real-world analysis of 938 patients with stage II, MMR-proficient colorectal cancer confirms the prognostic value of the Oncotype DX Colon Recurrence Score test.
