REDWOOD CITY, Calif., May 31 /PRNewswire-FirstCall/ — Genomic Health,
Inc. (Nasdaq: GHDX), provider of the Oncotype DX(R) breast cancer assay, today
announced results of two separate studies presented at the annual meeting of
the American Society of Clinical Oncology (ASCO), that could lead to the
development of new tests for predicting benefit from certain targeted
therapies in cancer, specifically cetuximab (ERBITUX(R)) for colon cancer and
docetaxel (Taxotere(R)) for breast cancer. Oncotype DX is the first and only
genomic test that predicts the likelihood of chemotherapy benefit as well as
likelihood of disease recurrence for early-stage breast cancer patients.
“These new data represent encouraging results of our work with leading
cancer cooperative groups and drug manufacturers to discover and develop
genomic tests to determine which patients are likely to benefit from treatment
with targeted therapies,” said Steven Shak, M.D., chief medical officer of
Genomic Health. “We believe this is an important step forward in
demonstrating the potential of a diagnostic and therapeutic partnership in
advancing the field of personalized medicine.”
The first study, “Evaluation of tumor gene expression and K-Ras mutations
in formalin-fixed, paraffin-embedded tumor tissue as predictors of response to
cetuximab in metastatic colorectal cancer,” (abstract 3512) represents the
first publicly presented results of Genomic Health’s collaboration with
Bristol-Myers Squibb and ImClone Systems Incorporated for ERBITUX (cetuximab),
a targeted therapy for colon cancer.
Researchers analyzed formalin-fixed, paraffin-embedded tumor samples from
226 colon cancer patients from three studies of ERBITUX. The samples were
examined for K-Ras gene mutations, which are commonly observed in colon
cancer, and for the expression of 102 previously identified candidate genes
that may be associated with disease control and progression-free survival in
patients treated with ERBITUX.
Of the 226 analyzed samples, 36 percent (82 patients) had K-Ras mutations
and a significantly lower disease control rate (23 percent) compared to those
who did not exhibit the gene mutation (60 percent). Among all 226 samples,
quantitative expression of 40 genes was significantly associated with disease
control. Together, the results suggest that quantitative expression of a
number of the candidate genes used in conjunction with K-Ras mutation status
increases the ability to predict which patients might benefit from treatment
with ERBITUX over K-Ras status alone.
“Based on these results, we believe there is a potential to develop a
multi-gene test comprising K-Ras mutation status in combination with the
expression levels of a small number of genes to select patients for
cetuximab,” said Joffre Baker, Ph.D., chief scientific officer of Genomic
Health and lead author of the study.
The research for the second study, “Predictive utility of progesterone
receptor and multigene expression in identifying benefit from adjuvant
doxorubicin plus cyclophosphamide or docetaxel in intergroup trial E2197,”
(abstract 557) was led by the Eastern Cooperative Oncology Group (ECOG).
Researchers evaluated the predictive utility of progesterone receptor (PR)
protein expression by IHC in a central lab and quantitative RNA expression by
RT-PCR for 371 genes, including the current Oncotype DX 21-gene panel, for
treatment either with doxorubicin plus cyclophosphamide (AC), or with
doxorubicin plus docetaxel (AT). The study used samples from 734 patients who
received at least three to four treatment cycles.
Results showed that in patients with hormone receptor positive disease who
had an Oncotype DX Recurrence Score(TM) result greater than 18 (i.e., who were
classified as intermediate risk of recurrence or above), a number of candidate
genes strongly predicted benefit from treatment with docetaxel (Taxotere), a
type of taxane commonly used for breast cancer therapy. A genomic classifier
predicting differential benefit was identified and, if validated through
additional studies, might be useful in defining differential benefit of
docetaxel.
“We continue to gain meaningful insight into the biology of breast cancer
and now, possibly, treatment benefit for a common taxane regimen with our
ongoing study of the utility of Oncotype DX and additional breast cancer
genes,” said Lori J. Goldstein, M.D., Director of the Breast Evaluation Center
at Fox Chase Cancer Center in Philadelphia, Pennsylvania, and lead author of
the study. “Further research to narrow down which genes are most predictive
and validate their use could potentially yield a new panel of genes that may
predict the benefit of treatment with docetaxel.”
About Oncotype DX(R)
Oncotype DX is the first and only multi-gene expression test commercially
available that has clinical evidence validating its ability to predict the
likelihood of chemotherapy benefit as well as recurrence in early-stage breast
cancer. Oncotype DX has been extensively evaluated in multiple independent
studies involving more than 3,600 breast cancer patients, including a large
validation study published in The New England Journal of Medicine and a
chemotherapy benefit study published in the Journal of Clinical Oncology. To
date, 7,500 physicians have ordered more than 55,000 tests, and health plans
covering over 80 percent of U.S. insured lives provide reimbursement for
Oncotype DX through contracts, agreements and policy decisions. Both the
American Society of Clinical Oncology (ASCO) and the National Comprehensive
Cancer Network recommend the use of Oncotype DX for patients with
node-negative breast cancer that is estrogen-receptor positive and/or
progesterone-receptor positive. For more information about Oncotype DX, please
visit http://www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. (Nasdaq: GHDX) is a life science company focused on
the development and commercialization of genomic-based clinical laboratory
services for cancer that allow physicians and patients to make individualized
treatment decisions. In 2004, Genomic Health launched its first test,
Oncotype DX(R), which has been shown to predict the likelihood chemotherapy
benefit as well as recurrence in early-stage breast cancer patients. The
company was founded in 2000 and is located in Redwood City, California. For
more information, please visit www.genomichealth.com.
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, including statements
relating to the company’s belief that the results of these studies could lead
to the development of new tests for predicting the benefit of certain targeted
therapies used in the treatment of cancer. These risks and uncertainties
include, but are not limited to: the results of additional clinical studies;
the risk that we may not obtain sufficient levels of reimbursement for any
future tests we may develop; our ability to develop and commercialize new
products; the risks and uncertainties associated with the regulation of our
tests by FDA; our ability to obtain capital when needed; our history of
operating losses and the other risks set forth in our filings with the
Securities and Exchange Commission, including the risks set forth in our
Quarterly Report on Form 10-Q for the three-month period ended March 31, 2008.
These forward-looking statements speak only as of the date hereof. Genomic
Health disclaims any obligation to update these forward-looking statements.
NOTE: Genomic Health, 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.
SOURCE Genomic Health, Inc.