• New independent clinical evidence from the pivotal TAILORx and RxPONDER trials support the role of the Oncotype DX Breast Recurrence Score® test, the only genomic test to predict chemotherapy benefit in early-stage breast cancer patients [1],[2],[3],[4]
• The data presented includes a UK multi-centre trial involving 680 women with early breast cancer and lymph node involvement, showing that the use of Oncotype DX leads to over half of women being spared chemotherapy, with cost savings for the NHS of £1.7 million
• Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, today announced that new data presentations supporting the clinical value of its Precision Oncology portfolio will be shared in ten abstracts and three presentations at the 2022 San Antonio Breast Cancer Symposium® (SABCS®).

Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, announce that new data presentations supporting the clinical value of its Precision Oncology portfolio will be shared in ten abstracts and three presentations at the 2022 San Antonio Breast Cancer Symposium® (SABCS®). 

“The breadth of evidence presented at SABCS 2022 showcases Exact Sciences’ growing Precision Oncology portfolio and commitment to personalising cancer care and potentially enabling better outcomes at every step,” said Rick Baehner, M.D., chief medical officer of Precision Oncology. “We’re developing new tests to support cancer patients and strengthening the evidence of our current tests, including updated results from the landmark TAILORx and RxPONDER trials for the Oncotype DX test.”

An independent UK study evaluates the use of the Oncotype DX® test to guide chemotherapy decisions in node-positive breast cancer

A UK multi-centre trial involving 680 women with early breast cancer and lymph node involvement has shown that the use of Oncotype DX leads to over half of women being spared chemotherapy. In addition, both patients and their doctors were much more confident with their choice of treatment and there was a significant economic saving to the British healthcare system of £1.7 million.[5]

Simon Holt, Consultant Surgical Oncologist, NHS Wales, stated: “This trial shows that the use of Oncotype DX in early node positive breast cancer is a win for everyone. More than 50% of patients are spared unnecessary chemotherapy, doctors and patients become more confident they have chosen the correct treatment and the NHS saves money which can then be used for other priorities.”

12-year results from TAILORx trial confirm findings from previous analysis

An independently led analysis by ECOG-ACRIN Cancer Research Group with sponsorship from the National Cancer Institute (NCI) will highlight 12-year results from the Trial Assigning Individualised Options for Treatment (Rx) (TAILORx). The largest randomised adjuvant breast cancer trial ever conducted, TAILORx 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 (with a Recurrence Score® result of 26-100) for whom chemotherapy can be lifesaving.2,[6],[7]

The new 12-year analysis confirms findings from the original primary analysis that endocrine therapy (ET) is non-inferior to chemotherapy plus ET in patients with hormone receptor (HR)-positive, HER2-negative, node-negative early breast cancer and Recurrence Score results of 11 to 25.[8] As in the original exploratory analysis2, the subgroup of women aged 50 and younger with Recurrence Score results of 16 to 25 derive some chemotherapy benefit that persists out to 12 years. For those with Recurrence Score results of 0 to 25, late recurrence events beyond five years exceeded earlier recurrence; however, risk of distant recurrence at 12 years remains below 10%, still indicating low risk.

“The immediate clinical impact is that with longer follow-up, the main TAILORx study findings remain unchanged. Physicians can continue to use the 21-gene Recurrence Score results to guide decisions about the use of chemotherapy,” said Joseph A. Sparano, MD, deputy director of The Tisch Cancer Centre at Mount Sinai Health System. Dr. Sparano leads the TAILORx trial on behalf of the ECOG-ACRIN Cancer Research Group.

Two RxPONDER analyses provide a new perspective for breast cancer treatment

The Rx for Positive Node, Endocrine Responsive Breast Cancer (RxPONDER) trial demonstrated that the Oncotype DX test identifies the majority of early-stage breast cancer patients with one to three positive lymph nodes who may omit chemotherapy.[9]

An additional exploratory analysis of race and clinical outcomes data in the RxPONDER trial was selected for the SABCS press program. The analysis suggests that Black patients had worse outcomes compared to white patients that were independent of Recurrence Score result, treatment arm and grade.[10]  The underlying causes of the established racial differences in breast cancer risk and outcomes are complex and likely multifactorial, and the effects of socioeconomic factors and other social determinants of health on breast cancer research need to be further explored.

Another analysis of a questionnaire completed by a subset of patients in the RxPONDER trial demonstrated that cancer-related cognitive impairment is greater with chemotherapy plus endocrine therapy than with endocrine therapy alone, and this impairment lasts past three years of follow-up.[11] This analysis reinforces the importance of using the Oncotype DX test to ensure chemotherapy is only used for patients who will benefit. The RxPONDER trial was led by the independent SWOG Cancer Research Network and sponsored by NCI, and its original findings were published in The New England Journal of Medicine in 2021.

Data presentations including Exact Sciences’ Precision Oncology portfolio at SABCS 2022

Poster #P3-05-59: ER+ HER2-negative BRCA1/2 carriers breast cancer (BC) patients (n=81): Clinical outcomes and molecular characterization via the 21-gene Recurrence Score (RS) test vs. the general RS-tested population (799,986 samples)

Summary: This is a database cohort comparison of Oncotype DX Recurrence Score results, between patients with germline BRCA1/2 mutations and breast population undergoing Oncotype DX testing. BRCA1/2 carriers are characterised by higher Recurrence Score results and distinct gene expression profiles.[12]

Authors: Yerushalmi R, et al.

Date/Time: Tuesday, December 7, 7:00 a.m. CT

Poster #P2-23-11: Quantitative gene expression by RT-PCR in histologic subtypes of invasive breast carcinoma: an update in nearly one million cases

Summary: This Oncotype DX quantitative gene expression study highlights unique patterns of the Recurrence Score and single genes across the various histologic subtypes of invasive ductal carcinoma (IDC), suggesting that the Oncotype DX test may be used to further stratify patients with IDC and its histological subtypes.[13]

Authors: Can NT, et al.

Date/Time: Wednesday, December 7, 7:00 a.m. CT

Poster #P2-23-14: Molecular characterization of HER2-low invasive breast carcinoma by quantitative RT-PCR using Oncotype DX®

Summary: This is a multicentre report comparing Oncotype DX RT-PCR and immunohistochemical molecular characterization of HER2-low in HR+ invasive breast carcinomas.[14] 

Authors: Rozenblit M, et al.

Date/Time: Wednesday, December 7, 7:00 a.m. CT

Poster #P2-11-06: Plasma assay of methylated DNA markers (MDM) detects patients with metastatic breast cancer (MBC) compared to healthy controls and treated breast cancer patients with no evidence of disease

Summary: This is a marker discovery study to support a tumour-naive minimal residual disease (MRD) approach. The MDM assay successfully distinguished between patients with metastatic breast cancer and normal healthy control subjects.[15] 

Authors: Giridhar KV, et al.

Date/Time: Wednesday, December 7, 7:00 a.m. CT

Poster #P5-03-15: Application of 21-gene Breast Recurrence Score® assay to evaluate prognosis and benefit of adjuvant chemotherapy in BRCA1 and BRCA2 pathogenic variant carriers with early stage, oestrogen receptor positive breast cancer

Summary: This study shows that women with an inherited BRCA1/2 mutation are more likely to have a higher Oncotype DX Recurrence Score result than their matched controls for age, grade, and stage. These findings suggest that ER+ breast cancers with a germline BRCA1/2 mutation are biologically more aggressive.[16]

Authors: Saha P, et al.

Date/Time: Thursday, December 8, 5:00 p.m. CT

Poster #P5-14-12: ESR1-alterations in HR+HER2- breast cancer patients

Summary: An evaluation of ESR1 alterations in HR+ HER2- breast cancer samples sequenced by the Oncomap ExTra assay demonstrated that through comprehensive RNA sequencing, the test was uniquely able to identify both common and rare ESR1 fusions, which occurred most frequently in metastatic samples. This is important to potentially help guide treatment for patients who become refractory to endocrine therapy.[17] 

Authors: Basu G, et al.

Date/Time: Thursday, December 8, 5:00 p.m. CT

Poster #P6-01-39: The impact of the 21-gene Recurrence Score® assay upon physician treatment recommendations in the neoadjuvant setting in lymph node-negative breast cancer patients in Quebec

Summary: A multicentre, prospective Oncotype DX neoadjuvant decision impact study in HR+ lymph-node negative breast cancer patients in Quebec, Canada demonstrated the clinical utility of the test in decreasing the use of chemotherapy in the neoadjuvant setting.[18]

Authors: Yordanova M, et al.

Date/Time: Friday, December 9, 7:00 a.m. CT 

About Exact Sciences’ Precision Oncology portfolio

Exact Sciences’ Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score® test is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX® test is recognised as a standard of care and is included in all major breast cancer treatment guidelines. The Oncomap™ ExTra test applies comprehensive tumour profiling, utilising whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the Oncomap ExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. Exact Sciences enables patients to take a more active role in their cancer care and makes it easy for providers to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations.

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® tests, Exact Sciences is investing in its product pipeline to support patients before and throughout their cancer diagnosis and treatment. Exact Sciences unites visionary collaborators to help advance the fight against cancer.

NOTE: Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, Recurrence Score and Oncomap are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners.