Changing the future of breast cancer care: advancing personalized medicine powered by high-quality clinical evidence and new genomic solutions

This week, the Exact Sciences team and collaborators celebrated the publication of potentially practice-changing data from a large clinical trial in the prestigious The New England Journal of Medicine. The study, called RxPONDER, was led by the independent SWOG Cancer Research Network , a global clinical trial cooperative group, and sponsored by the National Cancer Institute. The women in the study had a common form of early breast cancer that had spread to 1 to 3 lymph nodes and an Oncotype DX Breast Recurrence Score? result of 0-25. The only validated genomic test to offer both predictive and prognostic insights for early-stage breast cancer patients, the Oncotype DX Breast Recurrence Score test provides critical information on whether or not a woman with early-stage, hormone receptor positive, HER2 negative breast cancer will benefit from chemotherapy, as well as the likelihood of her cancer returning, after treatment with appropriate therapy.

One of the largest clinical trials in women with this type of cancer, the RxPONDER study showed that the majority of postmenopausal women (those with a Recurrence Score? result of 0-25), with 1 to 3 positive lymph nodes, were able to forgo chemotherapy after surgery without increasing the risk of their cancer returning.[1] This is big news for tens of thousands of women worldwide and has the potential to improve care and outcomes for a group of patients traditionally considered at higher risk of worse outcomes and commonly recommended chemotherapy. [2] ,[3] The RxPONDER findings, combined with the results from the landmark TAILORx clinical trial , a study in women with a common type of breast cancer that had not yet spread to the lymph nodes, represent one of the biggest advancements in breast cancer care in the last several decades, with the Oncotype DX? test at the center, fundamentally changing how physicians select patients with early breast cancer for chemotherapy.

The statistics are sobering: breast cancer has now overtaken lung cancer as the world’s most common cancer[4] , and it also tops the list of newly diagnosed cases each year[5] . But with advances and progress made in risk assessment, screening, and therapies, most women today not only survive their breast cancer diagnosis, they do so with less invasive surgery and fewer toxic treatments, like chemotherapy.[6]

As part of Exact Sciences’ mission to change the way we detect and treat cancer, our company is leading the way in using genomic insights to help improve care for millions of women with early and late-stage breast cancer, while advancing new solutions to help women and their physicians make better informed choices. Here are our keys to success:

Start with a guiding principle ? breast cancer treatment is not a one-size-fits-all approach

For decades, breast cancer treatment was often a universal approach involving invasive surgery followed by chemotherapy and possible radiation. We now know that not all patients and not all tumors are the same. Personalized medicine, or tailoring treatment to the biology of each patient's tumor is a key to better outcomes for breast cancer patients, with the potential to reduce healthcare costs from unnecessary treatments. The introduction of the Oncotype DX test in 2004 revolutionized the precision medicine movement in cancer care, inexorably changing the way physicians approach chemotherapy treatment decisions.

The impact of empowering women with the knowledge to enable them to make confident treatment choices with their provider is profound. Avoiding chemotherapy allows women to avoid the harsh side effects associated with the treatment, including nausea, hair loss, tiredness, and increased risk of developing infections[7] ? for women whose cancer has already spread to their lymph nodes and who might have automatically received chemotherapy in the past, this is especially meaningful. For women with more aggressive disease for whom chemotherapy can be lifesaving[8] , they have confidence they’re choosing a treatment that’s right for them.

To date, nearly 1.3 million patients in more than 90 countries have relied on the Oncotype DX test to make better-informed treatment choices for their breast cancer, and we estimate that approximately 1 million of them have been able to avoid chemotherapy, based on their Recurrence Score result.[9]

Set your standards high; patient lives are at stake

A defining focus of ours at Exact Sciences is to create high-quality diagnostic tests, using advanced technology and rigorous, data-backed science. There are no shortcuts when developing tests that impact patient lives. Innovation and advancements in healthcare are possible, but they must always be done rigorously, using best practices and conducted to the highest standards. ?

As one of the most extensively studied genomic tests available for breast cancer patients today, the Oncotype DX test provides an excellent case in point. The RxPONDER results deliver the highest level of evidence and build on the critical mass of research supporting the test as the standard of care. The data also underscore the importance of a thoughtful and strategic approach to clinical data generation, making sure that we conduct the right studies and collaborate with third-party experts to build robust use cases and to support eventual insurance coverage of a test, so everyone can have access to them.

Build on your success to deliver even more life-changing advancements

The Oncotype DX test provides definitive answers on chemotherapy benefit, yet so many opportunities to provide breast cancer patients and their physicians with smarter, personalized answers about what treatments may be right for them at all stages of the disease remain. We are building an arsenal of solutions to answer these questions, including our Oncotype MAP? Pan-Cancer Tissue test, a comprehensive tumor profiling test for all solid tumors, which can provide critical therapy selection results for breast cancer patients who have late-stage or disease that has spread throughout the body. We also have in our pipeline a promising new genomic test designed to evaluate the activity of 16 cancer genes with the goal of determining benefit from radiation therapy after breast-conserving surgery (the current standard of care). Being able to provide women with a clear answer to this question has the potential to minimize over- or under-treatment and allow women and their physicians to further personalize their treatment plans.

To showcase continued progress in our breast cancer portfolio of tests, new data will be presented this December at the San Antonio Breast Cancer Symposium , the leading forum for breast cancer research, that further elevate the Oncotype DX test to standard of care and highlight the above-mentioned test in development to determine radiation therapy benefit.

As we look toward the future of breast cancer care, we foresee minimal residual disease solutions, which detect fragments of genetic information shed by a patient’s tumor, to play an important role in predicting cancer recurrence for many types of cancer, including breast cancer, and have started early research into how we can use this exciting technology to continue to shape the future of precision medicine. At Exact Sciences, we will remain relentless and unwavering in our pursuit to improve outcomes for even more women.

[1] Kalinsky, K. et al., New Engl J Med. 2021

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

[3] Allemani et al, Int J Cancer 2013

[4] American Cancer Society: https://pressroom.cancer.org/GlobalCancerStats2020 , Accessed 11/16/2021

[5] Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Pi?eros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. International Agency for Research on Cancer. Available from: https://gco.iarc.fr/today, accessed 11/10/21

[6] ASCO.org, Breast Cancer Statistics: https://www.cancer.net/cancer-types/breast-cancer/statistics

[7] American Cancer Society, Side Effects of Chemotherapy: https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/chemotherapy/chemotherapy-side-effects.html

[8] Sparano, J. et al. N Engl J Med. 2018 Jul 12;379(2):111-121.

[9] Data on file.