Lilly Breast Cancer Studies Explore Potential Role of Pharmacogenomics in Customizing Chemotherapy
04 June 2006 - 7:45AM
PR Newswire (US)
ATLANTA, June 3 /PRNewswire-FirstCall/ -- At the 42nd American
Society of Clinical Oncology (ASCO) annual meeting in Atlanta, Ga.,
Eli Lilly and Company, a leader in thoracic cancer, unveiled two
breast cancer studies involving pharmacogenomics and its
chemotherapies GEMZAR(R) (gemcitabine HCl) and ALIMTA(R)
(pemetrexed). They are among the early trials involving
pharmacogenomics (the study of gene expression patterns) in breast
cancer treatment. Richard Gaynor, M.D., vice president, cancer
research and global oncology platform leader for Lilly said, "While
these are preliminary trial results, the hope is that in the
future, treatment-predictive pharmacogenomics may lead to highly
tailored treatments that offer optimum patient outcomes." While
breast cancer has been the focus of much research and attention
over the years, it is only in recent times that this cancer has
been recognized as not one but many diseases, according to Vered
Stearns, M.D., assistant professor of oncology, Johns Hopkins
School of Medicine and an ASCO presenter on the subject of breast
cancer and pharmacogenomics. Stearns said, "This new outlook on
breast cancer will move treatment from the 'one-size-fits-all' to
the personalized medicine approach." "Right now, we treat cancer
based on stage, age, other diseases, etc., as opposed to what the
actual cancer of that woman looks like," said Stearns, adding, "And
we tend to over-treat because we're worried about the cancer coming
back. Pharmacogenomics can help analyze tumors' specific genetic
make- up to potentially guide cancer treatment decisions, thereby
avoiding unnecessary toxicity, and leading to better patient
outcomes." According to Gaynor, chemotherapies, which remain the
foundational therapies of choice, may experience a new resurgence
if pharmacogenomics can be employed in hopes of maximizing
treatment success. This "right patient, right drug, right time"
philosophy is what guides Lilly Oncology. "Cancer is personal -- it
affects different people differently, from a biological,
physiological, and psychological perspective," said Gaynor. "And
Lilly is responding by working to personalize and optimize its
prevention and treatment, with innovative research and solutions
including chemotherapies, targeted agents and pharmacogenomics."
Expression profiles can predict chemotherapy response in breast
cancer patients In a correlative study on a combined analysis of
approximately 90 women receiving neoadjuvant (pre-surgical)
chemotherapy, researchers sought to identify gene expression
profiles/biomarkers that predict patients' response to
chemotherapy. They also tried to determine whether these biomarkers
were drug-specific. Scientists from the University of North
Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center and
Lilly Research Laboratories in Indianapolis, Ind. evaluated two
groups of locally advanced breast cancer patients receiving
chemotherapy. DNA microarray analysis (a technologically advanced
way to perform quicker analyses of many genes in a single
experiment) was performed on pre-treatment core biopsies from the
patients. They then treated the first group of patients (L9819)
with four cycles of doxorubicin + cyclophospharmide (AC), followed
by four cycles of paclitaxel (Taxol(R)) or paclitaxel + trastuzumab
(Herceptin(R)). The second group of patients (S329) received four
cycles of Gemzar + doxorubicin followed by four cycles of Gemzar +
cisplatin. Clinical response was based on RECIST criteria.
Successful microarrays were obtained on 45 of the L9819 group and
46 of the S329 group, and separate analyses on each dataset
identified gene expression patterns that predicted with 75-80
percent accuracy clinical response on those patients that completed
all eight cycles of chemotherapy. Comparisons of both L9819 and
S329 predictors indicated that the study may provide the means to
predict response related to both general and drug- specific
chemotherapy, in this case Gemzar. (For data on adverse effects,
refer to the institutional, clinical trial for which this trial ran
as a correlative study: LCCC 9818: A Nonrandomized Phase II Study
Of Multimodality Therapy For Stage IIB, IIIA/B, Or Initially
Presenting Stage IV Breast Cancer With 4 Cycles Of AC Followed By
12 Weeks Of Single Agent Taxol(R) With Or Without Herceptin(R)
Followed By Local Therapy Followed By Weekly Herceptin(R) Or No
Additional Therapy.) Phase II Study of Alimta as first-line therapy
for advanced breast cancer Another Lilly study compared two doses
of Alimta in advanced breast cancer, and attempted to identify
potential biomarkers. The main objective of the study was to access
response rate on the two arms, and conduct exploratory biomarker
analysis. Further analysis of this study will be released at ASCO
on Sunday, June 4, 2006 at 2:00 pm EDT. About Gemzar(R) Gemzar,
celebrating its 10th anniversary in the US, is approved in more
than 90 countries and has been prescribed to more than 1.3 million
patients worldwide. It is the foundation for many drug
combinations, and the focus of much clinical research. Gemzar
interferes with the processes of DNA production, preventing cancer
cell replication, and therefore, stopping or slowing tumor growth.
Possessing broad activity across numerous tumor types, Gemzar is
the worldwide standard of care for pancreatic cancer and is also a
standard of care in many parts of the world for non-small cell
lung, metastatic breast and bladder cancers. Gemzar is also
approved in a number of European countries for recurrent ovarian
cancer, and in Mexico for metastatic cervical cancer. About
ALIMTA(R) Alimta was first approved by the US Food and Drug
Administration in 2004 for second-line treatment of non-small cell
lung cancer (NSCLC), and for malignant pleural mesothelioma. In the
two years since its first approval for marketing, Alimta has been
approved in 71 countries for either NSCLC or mesothelioma and has
become the leader for these indications in most markets. Delivered
via a 10-minute infusion that shows virtually no hair loss, Alimta
is an antifolate, which interferes with a crucial process that
allows cancer cells to reproduce and spread. Lilly Oncology, a
Division of Eli Lilly and Company For more than four decades, Lilly
Oncology has been collaborating with cancer researchers to deliver
innovative treatment choices and valuable programs to patients and
physicians worldwide. Inspired by the courageous patients living
with cancer, Lilly Oncology is providing treatments that are
considered global standards of care and developing a broad
portfolio of novel targeted therapies to accelerate the pace and
progress of cancer care. To learn more about Lilly's commitment to
cancer, please visit http://www.lillyoncology.com/. Eli Lilly and
Company Lilly, a leading innovation-driven corporation, is
developing a growing portfolio of first-in-class and best-in-class
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers -- through medicines and information -- for
some of the world's most urgent medical needs. P-LLY Gemzar(R)
(gemcitabine HCl), Lilly ALIMTA(R) (pemetrexed), Lilly Taxol(R)
(paclitaxel), Bristol-Myers Squibb Herceptin(R) (trastuzumab),
Genentech This press release contains forward-looking statements
about the potential of Gemzar and ALIMTA for the treatment of
breast cancer and reflects Lilly's current beliefs. However, as
with any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
There is no guarantee the product will receive regulatory approval
for a further indication, or that it will continue to be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Gregory L. Clarke of Eli Lilly,
+1-317-276-5222, mobile: +1-317-554-7119, ; Martin Blair of CPR
Worldwide, +1-212-453-2349, mobile: +1-646-337-6779,
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