On May 26, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present 15 abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2023, June 2-6, in Chicago, Illinois (Press release, Exact Sciences, MAY 26, 2023, View Source [SID1234632141]). 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.1-5
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A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. (PRNewsfoto/EXACT SCIENCES CORP)
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.1-2 Earlier analyses showed that an MCED test more than doubled the number of screening-detected cancers compared to standard-of-care screening methods alone.6 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.
"These first-ever, long-term MCED follow-up data confirm Exact Sciences’ approach to detecting multiple cancers at earlier stages of disease, and show that early detection enables successful treatment and long-term freedom from cancer in patients," said Tom Beer, MD, Chief Medical Officer, Multi-Cancer Early Detection, Exact Sciences. "A vast majority of cancers have no screening option today, and an accurate screening method, capable of detecting multiple cancers, is key to decreasing the number of cancer deaths. We look forward to advancing our MCED program with new data presentations at future medical meetings throughout the rest of the year."
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.
"These data continue to clearly show the proven and consistent value of our Oncotype DX Breast Recurrence Score test and its ability to detect a breast cancer patient’s need for chemotherapy after surgery across various histologic sub-types," said Rick Baehner, MD, Chief Medical Officer, Precision Oncology, Exact Sciences. "This ASCO (Free ASCO Whitepaper) presentation offers reassurance to healthcare providers that the Recurrence Score provided to their ILC patients nine years earlier, continues to confidently inform treatment decisions."
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.4-5,7-10
Further data sets detail the results from a study estimating the undiagnosed cancer incidence in the U.S.15 , and additional studies with OncoExTra, Oncotype DX Breast Recurrence Score, and Oncotype DX Colon will also be presented.11-13
Data presentations across Exact Sciences’ Screening and Precision Oncology portfolios at ASCO (Free ASCO Whitepaper) 20231-5, 7-16:
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.
Abstract e16175 (E-pub): Genomic profiling of biliary tract carcinomas by their location
Authors: Gatalica Z, et al.
Date/Time: N/A
Location: N/A
Key Findings: Whole-exome and whole-transcriptome sequencing of biliary tract cancer samples found actionable alterations in 153 of 155 samples (98.7%). Some alterations were associated with location, indicating that appropriate therapies for biliary tract cancers may differ by location.
Screening
Abstract 10580/Poster Pd #213: Colorectal cancer screening with blood-based tests: Estimated impact of a 1-, 2-, or 3-year screening interval compared with annual FIT and triennial mt-sDNA strategies
Authors: Lieberman D, et al.
Date/Time: Saturday, June 3, 1:15 p.m. – 4:15 p.m. CT
Location: Hall A
Key Findings: As compared to Cologuard, blood-based tests have limitations that result in more colonoscopies per life year gained. When compared to real-world adherence for mt-sDNA and FIT, blood-based tests with 1- and 2-year intervals and perfect adherence had higher LYG with the tradeoff of a greater number of diagnostic colonoscopies.
Abstract 10567/Poster Bd #200: The impact of extending CRC screening to the older population – results from CRC-AIM microsimulation model
Authors: Ebner D, et al.
Date/Time: Saturday, June 3, 1:15 p.m – 4:15 p.m. CT
Location: Hall A
Key Findings: Extending CRC screening to the older population with continued mt-sDNA (Cologuard) demonstrated the best health outcomes compared to other modalities, such as colonoscopy and FIT testing. The study shows that in colorectal cancer screening, mt-sDNA is superior to FIT or blood testing among the older population.
Abstract 6642/Poster Bd #134: Estimated life-years gained and resultant cost savings from follow-up colonoscopy after a positive multi-target stool DNA (mt-sDNA) test for colorectal cancer screening in commercially insured and Medicare populations
Authors: Ebner D, et al.
Date/Time: Saturday, June 3, 1:15 p.m. – 4:15 p.m. CT
Location: Hall A
Key Findings: Follow-up colonoscopy after a positive mt-sDNA test is estimated to result in more life-years gained and reduced incidence and mortality compared to those without a follow-up colonoscopy. Additionally, a follow-up colonoscopy was estimated to be less expensive than opting for no follow-up colonoscopy.
Abstract e22514 (E-pub): Patient-provider communication factors associated with mt-sDNA screening for colorectal cancer
Authors: Zhu X, et al.
Date/Time: N/A
Location: N/A
Key Findings: Adherence to mt-sDNA screening and intention to re-screen was high and strongly associated with frequent conversations with healthcare providers.
Abstract e18911 (E-pub): Estimated value-based pricing for blood-based colorectal cancer screening test versus multi-target stool DNA test
Authors: Kisiel J, et al.
Date/Time: N/A
Location: N/A
Key Findings: Compared to annual, biannual, and triennial blood-based colorectal cancer screening tests, triennial mt-sDNA tests were estimated to be more effective at all intervals and 44% to 102% less costly. According to estimates, the maximum price of a blood-based test should not exceed $49 to be considered a cost-effective option compared to mt-sDNA.
Abstract e13548 (E-pub): Validating the use of machine-learning cancer staging algorithms for Medicare cost analyses
Authors: Smith R, et al.
Date/Time: N/A
Location: N/A
Key Findings: The previously-developed machine learning algorithms closely predicted the treatment costs of non-small cell lung cancer and colon cancer, particularly for early stages, and may be useful for future modeling studies.
Abstract 10634/Poster Bd #267: Correlation of unobserved incidence of cancer in earlier stages with the observed incidence
Authors: Chhatwal J, et al.
Date/Time: Saturday, June 3, 1:15 p.m. – 4:15 p.m. CT
Location: Hall A
Key Findings: This modeling study estimates that up to 70% of the eight most common stage I and II cancers may be undiagnosed. In addition, there is no available screening test for pancreatic, non-Hodgkin’s lymphoma, head and neck, and urinary bladder cancers, of which 33%-66% of early-stage cases are undiagnosed.
Abstract #e22508 (E-pub): A flexible quantitative framework to assess the potential contribution of early cancer detection to improved cancer survival.
Authors: Yu M, et al.
Date/Time: N/A
Location: N/A
Key Findings: Based on our target survival improvement of 20%, common trends emerged across 14 of the 15 cancer types: i) we observed that the bulk of survival improvement can be achieved by detecting most disease prior to stage IV; ii) the remaining survival improvement can be achieved by detecting most cancers just one stage earlier. The solution revealed that lung cancer as the one cancer type that required more aggressive earlier detection than others, an expected result given that lung cancer has both very high incidence and very poor survival.