New Publication of Long-term Data from Real-world Clinical Practice Confirms Conclusions of TAILORx
MADISON, Wis., December 12, 2019 – Exact Sciences Corp. (NASDAQ: EXAS) today announced new outcomes data from two large population-based studies, presented at the 2019 San Antonio Breast Cancer Symposium (SABCS®). The real-world evidence suggests that use of the Oncotype DX Breast Recurrence Score® test in clinical practice is consistent with previous clinical validation studies including TAILORx, the largest ever breast cancer treatment trial. This landmark study was featured in the William L. McGuire Memorial Lecture Award, which recognized Joseph A. Sparano, M.D., TAILORx study chair, for his leadership, collaboration and practice-changing achievements in breast cancer research.
“Last year, TAILORx established the highest level of evidence and unprecedented precision supporting the use of the Oncotype DX Breast Recurrence Score test to guide adjuvant chemotherapy treatment for women with early-stage breast cancer,” said Dr. Sparano, associate director for clinical research at the Albert Einstein Cancer Center and Montefiore Health System in New York, and vice chair of the ECOG-ACRIN Cancer Research Group. “I am honored to receive this prestigious award and pleased that the TAILORx results have been incorporated in major clinical practice guidelines and used to guide patient care around the world.”
Outcomes Data in Patients Age 50 or Younger Reinforce Ability of Oncotype DX® to Identify Those Who Can Be Treated with Hormone Therapy Alone
An analysis from the U.S. National Cancer Database in over 4,700 women age 40 or younger with node-negative disease showed a distribution of Recurrence Score® results consistent with existing clinical evidence, with as many as 80% of patients having low Recurrence Score results (0-25). Higher Recurrence Score results were associated with worse five-year overall survival.
Another analysis from the Surveillance, Epidemiology, and End Results (SEER) registry program of the National Cancer Institute (NCI) provides real-world evidence of the value of the Oncotype DX® test in patients age 50 or younger with node-positive disease (up to three positive nodes). Results from more than 2,500 patients indicated a significant association between Recurrence Score results and breast cancer-specific mortality (BCSM), with five-year BCSM of less than 2% in young patients with Recurrence Score results 0-25 and no or unknown use of chemotherapy reported.
New Publication of Long-term Data from Real-world Clinical Practice Confirms Major Finding of TAILORx Study
Separately, the first reported 10-year outcomes data, including distant recurrence risk, from a large cohort of patients using the Recurrence Score results to guide treatment decisions in clinical practice were recently published. This analysis from investigators working with Clalit Health Services, the largest health services organization in Israel, examined medical records of more than 1,300 patients with node-negative breast cancer and applied the Recurrence Score cut points established by the landmark TAILORx study.
The findings showed that use of chemotherapy was aligned with Recurrence Score results, and that patients with Recurrence Score results up to 25, the vast majority of whom were treated with hormonal therapy alone, had excellent outcomes at 10 years, with low rates of distant recurrence. For the group of patients with Recurrence Score results 11-25, there were no statistically significant differences in 10-year distant recurrence rates between patients who received chemotherapy and those treated with hormonal therapy alone. These results are consistent with the primary findings of the large TAILORx randomized clinical trial.
“The additional insight from the new analyses in young patients is consistent with, and further supports, the value of the Recurrence Score result in younger women,” said Steven Shak, M.D., chief medical officer, Exact Sciences. “We are pleased to see the publication of new real-world evidence that reinforces the paradigm established by the TAILORx study, which has influenced positive treatment guidelines updates over the past 18 months and is having an important impact on global reimbursement and standard use of the Oncotype DX test.”
Additional Oncotype DX Presentations at 2019 SABCS Reinforce Value of the Test in Multiple Patient Populations Throughout Disease Continuum
- A prospective multicenter study from Ireland in more than 120 patients with node-positive disease highlights the significant impact on treatment decisions and reduction in chemotherapy recommendations based on the Recurrence Score result.
- The largest clinical utility study to date with the Oncotype DX DCIS Score™ assessed the impact of the test on radiotherapy (RT) recommendations in more than 200 patients. Results showed that the test combined with clinicopathological features identified more women with an estimated low (<10%) 10-year risk of local recurrence after breast-conserving surgery, leading to a significant change in RT recommendations and significantly more women not receiving RT.
 Sammons S. et al. Poster : P3-08-10. San Antonio Breast Cancer Symposium; December 2019.
 Stemmer S. M. et al. NPJ Breast Cancer. 2019
 Sparano J. A. et al. New Engl J Med. 2018
 Mullally W. J. et al. Poster: P3-08-56. San Antonio Breast Cancer Symposium; December 2019.
 Rakovitch E. et al. Poster: P6-16-01. San Antonio Breast Cancer Symposium; December 2019.
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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, Breast Recurrence Score, DCIS Score, Genomic Prostate Score, Oncotype DX AR-V7 Nucleus Detect, and Oncotype IQ 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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