Exact Sciences Showcases Continued Progress in Cancer Diagnostics at ASCO 2020

  • New data and society guidelines support value of Oncotype DX Breast Recurrence Score® test in guiding neoadjuvant treatment decisions for newly diagnosed patients
  • Mayo Clinic collaboration yielding new data and insights on some of the deadliest cancers

MADISON, Wis., May 29, 2020 – Exact Sciences Corp. (NASDAQ: EXAS) today announced it is presenting new data at the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Program. These data further demonstrate the clinical value of the Oncotype DX Breast Recurrence Score® test and exemplify the research progress made by Exact Sciences’ Mayo Clinic collaboration toward smarter solutions across the cancer continuum.

Three studies of the Oncotype DX Breast Recurrence Score® test presented at ASCO20 highlight the value that the Oncotype DX® test can provide by personalizing and improving neoadjuvant treatment decisions (i.e., prior to surgery) in women with hormone receptor positive, HER2-negative breast cancer.  

The new data at ASCO20 add to existing evidence[1],[2],[3] and reinforce the value of the Oncotype DX test in light of recent COVID-19 pandemic recommendations.[4],[5]

“As health systems across the world respond to the COVID-19 pandemic, both cancer screenings and elective surgeries are being postponed,” said Dr. Anthony Lucci, professor of Breast Surgical Oncology at MD Anderson Cancer Center. “Based on the new data presented at ASCO20, the Oncotype DX test identified women with a low likelihood of responding to neoadjuvant chemotherapy, who may benefit from alternative approaches while awaiting surgery, such as neoadjuvant endocrine therapy at home. This approach could overcome some of the unique challenges we and our patients are currently facing during this public health crisis.”

Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score in young women with estrogen receptor-positive early breast cancer

Abstract Number: 514

This study included 76 women treated with neoadjuvant chemotherapy from the Young Women’s Breast Cancer Study, a multi-center prospective group of women diagnosed with breast cancer at age 40 or younger. The Oncotype DX test was performed on tumor specimens from core biopsies obtained from the patients prior to surgery. Results revealed that patients with a higher Recurrence Score result were more likely to achieve a pathologic complete response (pCR; no residual invasive tumor) with chemotherapy.

21-gene Recurrence Score assay as a predictor of pathological response in neoadjuvant chemotherapy administration for ER-positive/HER2-negative early-stage breast cancer

Abstract Number: e12630

Conducted in Spain, this study prospectively analyzed a group of 63 patients who received neoadjuvant chemotherapy after the Oncotype DX test was performed on tumor specimens from core biopsies. The analysis showed a strong correlation between pCR and Recurrence Score result. In particular, the Recurrence Score result was the most significant predictor of pCR when compared to other factors such as Ki67 (a classic prognostic factor), estrogen receptor status, and initial tumor size.

Prediction of response to neoadjuvant hormonal therapy (NAHT) using upfront Oncotype DX Breast Recurrence Score (RS): results from the SAFIA phase III trial

Abstract Number: 594

In this study, the Oncotype DX test was performed prior to surgery and patients with Recurrence Score results 0-30 received neoadjuvant endocrine therapy without chemotherapy. After four months of treatment, data from 142 patients showed that 97% of them had a clinical response or stable disease, suggesting that patients with a Recurrence Score result <31 can be offered neoadjuvant endocrine therapy alone with minimal risk of progression of disease.

Additional Abstracts Highlight Progress in Research and Development

Through a longstanding collaboration, researchers at Exact Sciences and Mayo Clinic continue to identify biomarkers associated with some of the deadliest forms of cancer. Abstracts accepted for presentation at ASCO20, including promising results in five different cancer types, are highlighted below.

Algorithm for blood-based panel of methylated DNA and protein markers to detect early-stage hepatocellular carcinoma (HCC) with high specificity

Abstract Number: 4577

A robust algorithm based on novel blood-based biomarkers provided higher sensitivity for early-stage HCC (70%) compared to other available blood-based methods (54% and 52%) and, therefore, could significantly impact HCC clinical management and patient outcomes.

Molecular detection of pancreatic neuroendocrine tumors using methylated DNA markers: discovery and tissue validation

Abstract Number: e16705

Four novel methylated DNA markers accurately discriminated pancreatic neuroendocrine tumors from controls with normal pancreas and buffy coat (≥ 95% accuracy for each marker). These markers also differentiated metastatic pancreatic neuroendocrine tumors from normal pancreas tissue.

Novel methylated DNA markers in plasma detect distant recurrence of colorectal cancer

Abstract Number: 4088

A panel of novel methylated DNA markers in plasma detected distant recurrent colorectal cancer with promising accuracy (96% in liver metastases, 78% in lung metastases, and 57% in peritoneal/nodal metastases). These data are a positive early signal for the clinical utility of methylated DNA markers for non-invasive post-treatment surveillance and treatment monitoring in colorectal cancer.

Methylated DNA markers for plasma detection of ovarian cancer: discovery, validation, and clinical feasibility

Abstract Number: 6072

Whole methylome sequencing, stringent filtering criteria, and biological validation yielded candidate methylated DNA markers for ovarian cancer that performed with promisingly high sensitivity and specificity in plasma (79% sensitivity at 96% specificity). These data indicate that larger plasma-based ovarian cancer methylated DNA marker testing studies are warranted.

Methylated DNA marker panel for metastatic melanoma: discovery and tissue validation

Abstract Number: e22024

A panel of five novel methylated DNA markers assayed on tissue and undetectable in normal buffy coat achieved a very high discrimination between melanoma and benign control tissues (94% for metastatic melanoma and 85% for primary melanoma). This panel can be assessed in blood or other bodily fluids for application in melanoma surveillance.

ASCO20 will be conducted May 29-31, 2020.

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About Oncotype DX

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score® test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of the Cologuard® and Oncotype DX tests, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company’s website at  www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

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

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Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales, marketing and patient adherence efforts, expectations concerning payer reimbursement, and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. 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: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; 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; the success of our efforts to facilitate patient access to Cologuard via telehealth; 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 the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Society of Clinical Oncology, the American Cancer Society, and the National Committee for Quality Assurance 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, such as through our Promotion Agreement with Pfizer, Inc., and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; our ability to manage an international business and our expectations regarding our international expansion and opportunities; the potential effects of foreign currency exchange rate fluctuations and our efforts to hedge such effects; the possibility that the anticipated benefits from our combination with Genomic Health cannot 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 Genomic Health’s operations will be greater than expected and the possibility of disruptions to our business during integration efforts and strain on management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; and the other risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. 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.

[1] Iwata H, et al. Breast Can Res Treat. 2019.

[2] Pivot X, et al. Oncologist. 2015.

[3] Kantor O, et al. Ann Surg Oncol. 2019.

[4] Dietz JR, et al representing the COVID-19 Pandemic Breast Cancer Consortium. Breast Can Res Treat. 2020

[5] https://www.esmo.org/guidelines/cancer-patient-management-during-the-covid-19-pandemic/breast-cancer-in-the-covid-19-era.



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