Genomic Health Announces Publication of Positive Oncotype DX® Validation Study in Asian Patients with Stage II and Stage III Colon Cancer | oncotest
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Genomic Health Announces Publication of Positive Oncotype DX® Validation Study in Asian Patients with Stage II and Stage III Colon Cancer

Findings of SUNRISE Study Published in the Journal of Clinical Oncology

[June 21, 2016] — Genomic Health announced that the Journal of Clinical Oncology (JCO) published positive results from the large SUNRISE clinical validation study[1] of the Oncotype DX® Colon Recurrence Score™. The findings confirm that the Colon Recurrence Score accurately predicts recurrence risk in stage II and III colon cancer patients, providing information beyond conventional factors. SUNRISE is the first Oncotype DX colon cancer validation study in resected patients with stage III disease not treated with chemotherapy. The study also establishes the test’s clinical validity in Asian patients.

“This very important study in an Asian patient population confirms that Oncotype DX provides independent information regarding individual tumor biology and enhances our ability to identify the most appropriate treatment plan for each patient,” said Dr. Takayuki Yoshino, Director, Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan and lead investigator of the study. “The Recurrence Score result has shown us that there is a continuous biology in colon cancer with associated risk of recurrence implications beyond information gleaned from traditional staging. This critical understanding of where a patient falls on that continuum is going to help both stage II and stage III colon cancer patients and their physicians make more informed decisions regarding adjuvant therapy.”

The study analyzed results from an observational cohort of 597 stage II and III colon cancer patients from 12 Japanese hospitals who were consecutively enrolled and underwent surgery alone between 2000 and 2005, before adjuvant chemotherapy was standard of care in Japan for stage III patients. The researchers found that recurrence risk increased with increasing Recurrence Score® results:

  • In patients with stage II disease, the average recurrence risk at five years was 9 percent, 14 percent and 19 percent in the predefined low, intermediate and high recurrence risk groups, respectively
  • In patients with stage IIIA/B disease, the average recurrence risk at five years was 20 percent, 29 percent and 38 percent

Notably, stage IIIA/B patients with low Recurrence Score results had a five-year risk of recurrence similar to stage II patients with high Recurrence Score results. In the study, the continuous Recurrence Score result was associated (all p<0.001) with recurrence-free interval, recurrence-free survival, disease-free survival, and overall survival.

Results from SUNRISE are consistent with previous clinical validation studies QUASAR[2], NSABP C-07[3] and CALGB 9581[4], and add to the body of clinical evidence, which now includes data in more than 2,200 colon cancer patients supporting the test’s clinical validity.

More than [insert number] people are diagnosed with colon cancer each year in [insert country]. The decision to treat patients with chemotherapy following surgery in stage II disease is based on an assessment of how likely their disease is to recur. In stage IIIA/B disease, more accurately classifying those with lower recurrence risk allows physicians to identify patients who, accordingly, may not derive substantial gains in absolute treatment benefit from the addition of oxaliplatin to fluorouracil-based adjuvant chemotherapy regimens.

About Oncotype DX

Oncotype DX is a multi-gene test that can help men and women with some types of colon cancer learn more about the biological features of their specific tumor. The test evaluates a select 12-gene set taken from an individual’s colon cancer sample to see how they are expressed, or how active they are. The results of the test are reported as a quantitative Recurrence Score result, which is a score between 0 and 100 that correlates with the likelihood of a person’s chances of having the colon cancer return (recurrence).

About Genomic Health

Genomic Health, Inc. is a world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of cancer. 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 600,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid and tissue-based tests. The company is based in Redwood City, California with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com

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 risks and uncertainties associated with the regulation of the company’s tests; the results of clinical studies and their impact on reimbursement and adoption; the applicability of clinical study results to actual outcomes; the company’s ability to develop and commercialize new tests and expand into new markets domestically and internationally; 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; the risks of competition; unanticipated costs or delays in research and development efforts; the company’s ability to obtain capital when needed 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 March 31, 2016. 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 and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

[1] Yamanaka T, Oki E, Yamazaki K et al, J Clin Oncol. 2016; Epub ahead of print DOI: 10.1200/JCO.2016.67.0414

[2] Gray RG, Quirke P, Handley K, et al. J Clin Oncol. 2011. 29(35): 4611-9

[3] Yothers G, O’Connell M, Lee M, et al. J Clin Oncol. 2013. 31(36): 4512-9

[4] Venook A.P., Niedzwiecki D. Lopatin M., et al. J Clin Oncol. 2013. 31(14): 1775-1781

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