EXACT SCIENCES CORPORATION - First results from the independent SWOG Cancer Research Network-led Phase III study to be presented at the 2020 San Antonio Breast Cancer Symposium
- RxPONDER results from over 5,000 women likely to transform the treatment of node-positive breast cancer, as the TAILORx study did in node-negative disease
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. Two-thirds of the women in the trial were postmenopausal.
The first results also demonstrated, after a median of five years of follow-up, that premenopausal women with Recurrence Score results 0-25 were observed to have a statistically significant chemotherapy benefit, with an average improvement in distant recurrence rates at 5 years of 3%.
Approximately 85% of women with node- positive disease have Recurrence Score results of 0 to 25. ii Postmenopausal and premenopausal women with Recurrence Score results 26-100 were not included in the study because investigators reviewed prior studies and determined that this patient group had chemotherapy benefit. The SWOG investigators intend to publish the detailed RxPONDER results in a peer-reviewed publication.
"Every day in clinics around the world, physicians wrestle with the question of how to best treat women with this common form of breast cancer," said study lead author
Approximately 25% of patients diagnosed with hormone receptor (HR)-positive, HER2-negative early breast cancer have tumor that has spread to their lymph nodes and two out of three are postmenopausal.iii The vast majority of these patients currently receive chemotherapy.iv
"With the RxPONDER and TAILORx trials, there is now definitive and undeniable clarity on who does and who does not benefit from chemotherapy among early-stage breast cancer patients, with either node-negative or node positive disease," said
One of the largest clinical trials in women with node-positive HR+, HER2- early breast cancer, RxPONDER is a prospective, randomized Phase III study conducted at 632 sites in nine countries –
The use of the Oncotype DX test in early-stage breast cancer is supported by prospective outcomes from more than 17,000 patients with node-positive disease and more than 83,000 patients with node-negative disease, including the TAILORx study. Results from TAILORx, published in 2018, showed that the Oncotype DX test identifies the vast majority of women with node-negative disease who receive no substantial benefit from chemotherapy (approximately 80%), as well as the important minority for whom chemotherapy can be life-saving.
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
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests,
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
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. Therefore, 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
i Kalinsky, K. et al. Oral Presentation: [GS3-00]. San Antonio Breast Cancer Symposium;
ii
iii Heer E. et al., The
iv Zhang et al., Breast Can Res Treat 2020
Investors: | Media ( | Media ( |
Federico Maiardi | ||
+1 608-535-8815 | +1 608-556-4380 | +41 79-138-1326 |
meganjones@exactsciences.com | sspanos@exactsciences.com | fmaiardi@exactsciences.com |
View original content to download multimedia:http://www.prnewswire.com/news-releases/rxponder-study-results-demonstrate-that-the-oncotype-dx-test-can-now-spare-chemotherapy-use-in-the-majority-of-women-with-node-positive-early-stage-breast-cancer-301189156.html
SOURCE
© Canada Newswire, source
