Exact Sciences : New Analysis Reinforces Cost-Effectiveness of the Oncotype DX Breast Recurrence Score® Test in Node-Positive Early-Stage Breast Cancer

New Analysis Reinforces Cost-Effectiveness of the Oncotype DX Breast Recurrence Score® Test in Node-Positive Early-Stage Breast Cancer

By Exact Sciences / May 26, 2021

• Improved quality of care and significant cost savings using the test to guide adjuvant chemotherapy treatment

• Analysis based on first results from the independent RxPONDER study which identified the majority of women with one to three positive nodes who receive no benefit from chemotherapy

MADISON, Wis., May 19, 2021 -

Exact Sciences today announced results from a health economic analysis^[i]of the Oncotype DX Breast Recurrence Score^® test, accepted at the 2021 American Society of Clinical Oncology (ASCO) Annual Meetingand published online in the ASCO meeting library.This analysis shows the positive impact of initial results from the RxPONDER trial^[ii]on the test's cost-effectiveness in postmenopausal women with one to three positive lymph nodes.

Based on this updated model, adding data from RxPONDER leads to further cost-savings and potentially improved outcomes by avoiding short- and long-term adverse effects of chemotherapy without increased distant recurrence risk. The findings showed that chemotherapy can be spared for the majority of postmenopausal women, those with Recurrence Score^®results 0-25, increasing expected cost-savings without compromising patient outcomes and resulting in 50% greater cost-savings compared to the pre-RxPONDER scenario. The impact on cost-effectiveness was examined based on the list price for the test in the UK.^[iii]The potential impact of the Recurrence Score for HR-positive, HER2 negative post-menopausal women in the real-life setting may yield even greater savings and is currently being investigated in multiple European studies.

Approximately 25% of patients diagnosed with HR-positive, HER2-negative early breast cancer have a tumor that has spread to their lymph nodes and two out of three are postmenopausal.^[iv]The vast majority of these patients currently receive chemotherapy,^[v]although approximately 80% of them could be expected to have Recurrence Score results of 0 to 25.^[vi]

Initial results from the RxPONDER trial, which was led by the independent SWOG Cancer Research Network and sponsored by the National Cancer Institute, were presented at the end of 2020. The findings indicated that postmenopausal women with up to three positive nodes and Recurrence Score results 0-25 were not observed to benefit from chemotherapy and may thus avoid the associated side effects of the treatment. Importantly, no chemotherapy benefit was observed regardless of the number of affected nodes, tumour grade, or size. The first trial results also concluded that premenopausal patients with a Recurrence Score result 0-25 derived a 2.9% benefit from chemotherapy on distant recurrence at five years.

These results, together with the foundational TAILORx results^[vii]in node-negative, early stage breast cancer, further elevate the test to a standard of care, supporting its inclusion in guidelines as well as its reimbursement and adoption on a global scale. The National Comprehensive Cancer Network^® (NCCN^®)^[viii]recently updated its guidelines for breast cancer and recognized the Oncotype DX Breast Recurrence Score test as the only test that can be used for prediction of chemotherapy benefit in early-stage breast cancer patients with one to three positive axillary lymph nodes, including micrometastases.^[ix]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 (one to three positive nodes) 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 TAILORx and RxPONDER trials to select patients for chemotherapy treatment.

# # #

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 tumour in order to optimise 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 three to five business days and allows physicians to understand a patient's tumour 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.

[i] Berdunov V. et al. Abstract #534, ASCO 2021.

[ii] Kalinsky, K. et al. Oral Presentation: [GS3-00]. San Antonio Breast Cancer Symposium; December 2020.

[iii] NICE^© Diagnostics Guidance DG34, December 2018. www.nice.org.uk/guidance/dg34 (accessed May 13, 2021)

[iv] Heer E. et al., The Lancet 2020.

[v] Zhang et al., Breast Can Res Treat 2020.

[vi] Bello et al., Ann Surg Ocol. 2018.

[vii] Sparano et al. New Engl J Med. 2018.

[viii] National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

[ix] Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer, V.3.2021© National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed May 17, 2021. To view the most recent and complete version of the guideline, go online to: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

# # #

Media Contact (U.S.) :

Stephanie Spanos
[e-mail]
608-556-4380

Media Contact (Canada, Europe, Asia, Latin America) :
Federico Maiardi
[e-mail]
[phone]

Investor Contact:
Megan Jones
[e-mail]
608-535-8815

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 Cologuard and Oncotype DX^®, 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, Recurrence Score, Oncotype MAP, 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.

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. You should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements 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.

Topics: Exact Sciences News, Company, Press Releases