Credit: Shutterstock photoGenomic Health, Inc.GHDX recently unveiled favorable 3-year study results from the large PlanB trial, demonstrating the efficacy of its Oncotype DX breast cancer assay in determining patients who need to undergo chemotherapy treatment. The trial outcomes were also published in the Journal of Clinical Oncology - the tri-monthly peer-reviewed journal of the American Society of Clinical Oncology (ASCO).
Genomic Health will present 5-year results from PlanB in the official European Breast Cancer Conference (EBCC-10) press program on March 10, followed by an oral presentation the next day, at a plenary session.
Currently, breast cancer is the most prevalent cancer type (other than skin cancer) among American women and the ASCO expects to witness about 246,660 new cases of invasive breast cancer in the U.S. in 2016. However, in spite of considerable progress observed in adjuvant breast cancer treatment, overtreatment of early stage patients due to decisions based on conventional prognostic factors still remains an essential clinical issue.
It is in this context that Genomic Health's Oncology DX Recurrence Score (RS) enables physicians to rightly choose patients fit to undergo aggressive treatments. This saves the rest from the unnecessary harmful side effects of such therapies. Evidently, per management, new global study data generated in the last six months proves that tens of thousands of patients with a low Recurrence Score can actually forgo chemotherapy.
The PlanB study, conducted across 93 centers in Germany, enrolled over 3,100 high-risk early-stage breast cancer patients, including node-positive patients who are already considered for chemotherapy based on standard parameters. Patients with RS results of 12 or more were given chemotherapy, while those with RS of 11 or less were given only hormonal therapy.
The trial findings demonstrated that women with Oncotype DX RS results of 11 or less reflected 98% disease-free survival rates at 3 years, despite having high-risk disease as per traditional parameters. This validated that patients with low RS can thus be spared from aggressive chemotherapy and its harmful side effects.
Per management, these trial results are in sync with the recently released study outcomes from the Trial Assigning IndividuaLized Options for Treatment (TAILORx), which further highlights the fact that Oncotype DX accurately predicts breast cancer recurrence and survival, on the basis of data collected from more than 50,000 patients.
A quick look at Genomic's recent history will reveal the unprecedented prospective patient outcomes for the Oncotype DX breast cancer tests, which the company has been witnessing across its four latest trials - the Surveillance, Epidemiology, and End Results program (SEER) of the National Cancer Institute; complete results from a multi-center study from Clalit Health Services; an additional analysis from TAILORx and the aforementioned German PlanB study.
Currently, 140,000 eligible patients in the U.S. do not avail of an Oncotype DX RS. We believe this compelling suite of trial outcomes will induce a meaningful increase in adoption of Genomic's Oncotype DX breast cancer assay as a standard of care that can facilitate critical therapy decisions. This in turn will hike the company's profits from this test.
With theglobal marketfor breast cancer diagnostics and drug technologies expected to reach $27 billion in 2019, at a CAGR of 4% through 2014-2019; we expect the PlanB outcome to expand Genomic's market share in the aforementioned space, going ahead.
Zacks Rank
Currently, Genomic has a Zacks Rank #3 (Hold). Some better-ranked medical stocks are Hill-Rom Holdings, Inc. HRC , OraSure Technologies, Inc. OSUR and Vascular Solutions Inc. VASC . All the three stocks sport a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
