Exact Sciences Presents New Long-Term Patient Outcomes in Multi-Cancer Early Detection and Breast Cancer Recurrence Testing at ASCO® 2023

• Exact Sciences' approach in multi-cancer early detection (MCED) confirmed in first-ever, long-term, follow-up data from an MCED trial^1-2
  
  
• Surveillance, Epidemiology, and End Results (SEER) program analysis shows continued, long-term confidence in prognostic value of the Oncotype DX Breast Recurrence Score^{® 3}
  
  
• New modeling data show superior health outcomes in colorectal cancer screening with Cologuard^® compared to blood-based tests, including lower mortality and more life-years gained^4,5

MADISON, Wis., May 26, 2023 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, announced today 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.^1-5

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 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 2023^{1-5, 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.

About Exact Sciences Corp. 
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. Building on the success of the Cologuard^® and Oncotype^® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. 

NOTE: Oncotype, Oncotype DX, Oncotype DX Colon Recurrence Score, Oncotype DX Breast Recurrence Score, and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners. 

About Cologuard^®

The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test.

For more information about the Cologuard test, visit www.cologuard.com. Rx only.

Forward-Looking Statements

This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results; our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated benefits of our acquisitions, including estimated synergies and other financial impacts.

Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; our reliance upon certain suppliers, including suppliers that are the sole source of certain products; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition for our products and services; the effects of any judicial, executive or legislative action affecting us or the healthcare system; recommendations, guidelines and quality metrics issued by various organizations regarding cancer screening or our products and services; our ability to successfully develop new products and services and assess potential market opportunities; our ability to effectively enter into and utilize strategic partnerships and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; the results of our validation studies and clinical trials, including the risks that the results of future studies and trials may differ materially from the results of previously completed studies and trials; our ability to manage an international business and our expectations regarding our international expansion and opportunities; our ability to raise the capital necessary to support our operations or meet our payment obligations under our indebtedness; the potential effects of changing macroeconomic conditions, including the effects of inflation and interest rate and foreign currency exchange rate fluctuations and any such efforts to hedge such effects; our ability to efficiently and flexibly manage our business amid uncertainties related to the coronavirus ("COVID-19") pandemic; the possibility that the anticipated benefits from our business acquisitions will not be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of acquired businesses' operations or the divestiture of business operations will be greater than expected and the possibility that integration or divestiture efforts will disrupt our business and strain management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; our ability to retain and hire key personnel; and the impact of labor shortages, turnover, and labor cost increases. The risks included above are not exhaustive. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

References

[1] Buchannan A, et al. Abstract #3037, ASCO 2023.
[2] Lennon A, et al. Abstract #3039, ASCO 2023.
[3] Geyer C, et al. Abstract #554, ASCO 2023.
[4] Lieberman D, et al. Abstract #10580. ASCO 2023.
[5] Ebner D, et al. Abstract #10567. ASCO 2023.
[6] Lennon AM, et al. Feasibility of blood testing combined with PET-CT to screen for cancer and guide intervention. Science. 2020 Jul 3;369(6499):eabb9601.
[7] Ebner D. et al. Abstract #6642. ASCO 2023.
[8] Zhu X, et al. Abstract # e22514. ASCO 2023.
[9] Kisiel J, et al. Abstract #e18911. ASCO 2023.
[10] Smith R, et al. Abstract #e13548. ASCO 2023.
[11] Badve S, et al. Abstract #515, ASCO 2023.
[12] Brenner B, et al. Abstract #3620 ASCO 2023.
[13] Gatalica Z, et al. Abstract #e16175. ASCO 2023.
[14] Viatcheslav E K, et al. Abstract #3040. ASCO 2023.
[15] Chhatwal J, et al. Abstract #10634. ASCO 2023.
[16] Yu M, et al. Abstract #e22508 ASCO 2023.

Contacts

SOURCE EXACT SCIENCES CORP