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 Meeting and 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.

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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.