New NCCN Breast Cancer Guidelines Recognize Oncotype DX Breast Recurrence Score® Test

Oncotype DX^® Test Recognized as the “Preferred” and Only Multigene Test to Predict Chemotherapy Benefit in Node-positive Early-stage Breast Cancer

Update based on first results from the independent RxPONDER study presented at the 2020 San Antonio Breast Cancer Symposium¹

Madison, Wis., March 31, 2021 – Exact Sciences today announced that its Oncotype DX Breast Recurrence Score^® test has been recognized as the only test that can be used for prediction of chemotherapy benefit in early-stage breast cancer patients with 1-3 positive axillary lymph nodes, including micro metastases, by the National Comprehensive Cancer Network (NCCN)² in its updated guidelines for breast cancer.³ The Oncotype DX^® test is now the only test classified as “preferred” with the highest level of evidence for node-negative and postmenopausal node-positive patients.

In addition, the Oncotype DX test is incorporated in the node-negative and postmenopausal node-positive NCCN treatment algorithms with a recommendation of “strongly consider”, using cutoffs defined by the TAILORx⁴ and RxPONDER trials to select patients for chemotherapy treatment.

NCCN is an alliance of 31 world-leading cancer centers dedicated to improving the quality and effectiveness of care provided to patients with cancer. The guidelines are updated on a regular basis according to current evidence. The latest version can be accessed online.

This guideline update follows the recent presentation of initial results from the Rx for Positive Node, Endocrine Responsive Breast Cancer, or RxPONDER, trial, led by the independent SWOG Cancer Research Network and sponsored by the National Cancer Institute. One of the largest clinical trials in node-positive hormone receptor (HR)-positive, HER2-negative early breast cancer, RxPONDER enrolled more than 5,000 women with up to three positive nodes and successfully defined the benefit of chemotherapy in patients with Oncotype DX Breast Recurrence Score results of 0 to 25.

RxPONDER showed a different effect of chemotherapy based on Recurrence Score^® results for postmenopausal and premenopausal women. Postmenopausal women with Recurrence Score results 0-25 were not observed to show benefit from chemotherapy and may avoid the associated side effects of the treatment. Importantly, no chemotherapy benefit was observed regardless of the number of affected nodes, tumor grade, or size. The first trial results also demonstrated that premenopausal patients with a Recurrence Score result 0-25 derived a 2.9% benefit from chemotherapy on distant recurrence at five years. 

Approximately 25% of patients diagnosed with HR-positive, HER2-negative early breast cancer have a tumor that has spread to their lymph nodes and approximately two out of three are postmenopausal.⁵ The vast majority of these patients currently receive chemotherapy⁶ despite approximately 85% of them having Recurrence Score results of 0 to 25.⁷

The SWOG investigators intend to publish the detailed RxPONDER results in a peer-reviewed publication.

¹Kalinsky, K. et al. Oral Presentation: [GS3-00]. San Antonio Breast Cancer Symposium; December 2020.
²National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN.
³NCCN Guidelines: Breast Cancer, version 3.2021
⁴Sparano et al. New Engl J Med. 2018.
⁵Heer E. et al., The Lancet 2020.
⁶Zhang et al., Breast Can Res Treat 2020.
⁷Bello et al., Ann Surg Ocol. 2018.

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Media Contact: Investor Contact:

Steph Spanos
sspanos@exactsciences.com
608-556-4380

Erik Holznecht
eholznecht@exactsciences.com
608-201-6683

About the Oncotype DX^® and Oncotype MAP™ Portfolio of Tests

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. For patients with advanced and metastatic cancer, the company offers the Oncotype MAP™ Pan-Cancer Tissue test, a rapid, comprehensive tumor profiling panel, which provides results in 3-5 business days and allows physicians to understand a patient’s tumor profile and recommend actionable targeted therapies or clinical trials. 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 and Oncotype MAP tests, visit www.OncotypeIQ.com.

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, Oncotype DX Breast Recurrence Score, Oncotype DX Breast DCIS Score, Oncotype DX Genomic Prostate Score, and Oncotype DX AR-V7 Nucleus Detect 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. 

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