New Real-World Clinical Practice Data Reinforces the Value of the Oncotype DX Breast Recurrence Score® Test for Patients, Physicians and the Health Care System

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Further demonstrate the test’s ability to impact treatment decisions with an overall reduction in chemotherapy use and underscore the value of broader access for patients

Geneva, Switzerland, March 23, 2018 / B3C newswire / -- Genomic Health today announced the presentation of new data with the Oncotype DX® test at the 11th European Breast Cancer Conference (EBCC-11) in Barcelona, Spain.

The presentations underline the substantial real-world evidence available for Oncotype DX and reflect the growing adoption of the test across Europe to personalize and improve the quality of clinical decisions, leading to better patient outcomes and more cost-effective treatment.

Data highlights include:

  • A study(1) which assessed the impact of the test on treatment decisions in patients from 27 centers across five Italian regions. A total of 1,738 patient cases collected between March 2016 and December 2017, including both lymph node negative and lymph node positive breast cancer, were analyzed. Results from this real-life clinical practice survey showed that 49% of those patients who were prescribed chemotherapy before testing were spared such treatment based on their Recurrence Score® result, while 12% of patients who were assigned to hormone therapy alone had chemotherapy added to their treatment plan after testing.

    These results are consistent with other international studies utilizing Oncotype DX and further demonstrate the clinical utility of the test and its impact in terms of potential savings to the healthcare system.
  • A decision impact study(2) with 110 patients from France which demonstrated that testing with the Breast Recurrence Score™ reduced the use of chemotherapy by 56.4%. More importantly, the study compared treatment decisions between different tumor boards before testing with the Oncotype DX test and showed a low level of concordance based on 20 randomly-selected cases.

    These findings are consistent with those of a survey conducted between August 2013 and January 2014 and recently published(3) that indicates significant heterogeneity in how early breast cancer patients are treated and substantial uncertainty in treatment recommendations for a large proportion of patients, thus highlighting the need for better evidence to inform treatment decisions and greater consistency in clinical practice. This is where a multigene test such as Oncotype DX, which is the only test available that is validated to accurately identify patients who are most likely to benefit from adjuvant chemotherapy, can play a key role in creating a recognized standard of clinical excellence in clinicians’ recommendations for breast cancer treatment.
  • A sub-analysis(4) from a study done in France which looked at the test utilization in real-life clinical practice in 126 patients with lobular breast cancer. The findings indicate that testing with Oncotype DX resulted in a 47% change in treatment decisions, leading to a 36% net reduction in chemotherapy use.

“These studies are very important and confirm the value of the test to standardize therapeutic strategies in hormone-sensitive breast cancer and to avoid, without risk, adjuvant chemotherapy in nearly 40% of women initially considered candidates for such treatment based on traditional criteria,” said Prof David Khayat, Head of Medical Oncology at Clinique Bizet, Paris; Founder and former President of the French National Cancer Institute.

 
About early-stage breast cancer and the Oncotype DX test
Oncotype DX is the only genomic test validated for its ability to predict the likelihood of chemotherapy benefit as well as risk of recurrence in early-stage breast cancer. Breast cancer is the most common cancer in European women(5) and affects many of them during their years dedicated to working and raising a family. While chemotherapy is routinely offered, research shows that less than 10 percent of patients with early-stage breast cancer actually benefit from it.(6)

The Oncotype DX test is designed to facilitate personalized clinical decisions by providing information about the biology of an individual breast cancer, with the potential to deliver financial benefits for healthcare systems. This is supported by substantial real-world evidence showing that the test can reduce the number of women undergoing unnecessary chemotherapy by up to 60 percent.(7)

Healthcare systems across Europe are recognizing the value of the test, which is incorporated in all major international clinical guidelines. Following assessment and recommendation by NICE, the Oncotype DX test is widely available to patients across the UK. In France, Oncotype DX is available through a funding mechanism for genomic tests. Other European countries where the test is reimbursed include Switzerland, Ireland, Greece and Spain.

About Genomic Health
Genomic Health, Inc. is the world’s leading provider of genomic-based diagnostic tests that help optimize cancer care, including addressing the overtreatment of the disease. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company’s flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 850,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype DX® AR-V7 Nucleus Detect™ test. The company is based in Redwood City, California with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealthFacebookYouTube and LinkedIn.

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements relating to the ability of any potential tests Genomic Health, Inc. may develop to optimize cancer treatment and the ability of the company to develop and commercialize additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the results of clinical studies and their impact on reimbursement and adoption; the applicability of clinical study results to actual outcomes; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's yearly report on Form 10-K for the quarter ended September 30, 2017. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Oncotype IQ, Oncotype DX Breast Recurrence Score, Recurrence Score, and Breast Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners. 


Contact

Federico Maiardi
Genomic Health
+41 79 138 1326
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(1) Cognetti F., Barni S., PB-166, presented at EBCC-11
(2) Antoine E.C., PB-130, presented at EBCC-11
(3) Aapro M. et al., The MAGIC survey in hormone receptor positive (HR+), HER2-negative (HER2-) breast cancer: When might multigene assays be of value?, The Breast 33 (2017) 191e199
(4) Furtos-Fanget C, PB-165, presented at EBCC-11
(5) EUCAN. 2012. Available at: http://eco.iarc.fr/EUCAN/CancerOne.aspx?Cancer=46&Gender=2
(6) Paik et al. J Clin Oncol. 2006 ; Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) et al. Lancet. 2012.
(7) Loncaster J et al, Eur J Surg Oncol 2017

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