- 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.
“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.”
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.
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.
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.
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.
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.
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.
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.
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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 Iwata H, et al. Breast Can Res Treat. 2019.
 Pivot X, et al. Oncologist. 2015.
 Kantor O, et al. Ann Surg Oncol. 2019.
 Dietz JR, et al representing the COVID-19 Pandemic Breast Cancer Consortium. Breast Can Res Treat. 2020