Lilly Announces Phase II Results for ALIMTA(R) in First-Line Metastatic Breast Cancer Trial
05 June 2006 - 5:00AM
PR Newswire (US)
Study Also Explored Biomarkers' Correlation to Drug Efficacy
ATLANTA, June 4 /PRNewswire-FirstCall/ -- At the 42nd American
Society of Clinical Oncology (ASCO) annual meeting in Atlanta, Ga.,
Eli Lilly and Company announced results of a Phase II trial
evaluating its leading thoracic cancer drug, ALIMTA(R) (pemetrexed)
in first-line metastatic breast cancer. The study also detailed
exploratory pharmacogenomic analyses, to potentially identify the
presence of specific biomarkers for Alimta. Lilly's study is among
the first bodies of research evaluating the potential use of
biomarkers with chemotherapy agents. The Phase II study was a
randomized, double-blind trial of 92 patients with locally advanced
or metastatic breast cancer (MBC). The two sets of patient groups
were given two different doses of Alimta. The study concluded that
since efficacy and safety for both doses were similar, the lower
dose (600 mg/m squared) is suitable for further study. In addition,
exploratory biomarker analysis suggests an efficacy correlation for
FFGS (folypolyglutamate synthase) and TP (thymidine phosphorylase).
"We are encouraged by these results," said Allen Melemed, M.D.,
Lilly associate medical director and a study author. "And while
it's too soon to be conclusive, it does seem like we're heading in
the right direction. Our hope is to be able to offer patients and
their doctors more choices, and to one day help them know with more
certainty, which ones work for them." Lilly is considering plans
for a Phase III trial, as well as further evaluation of the
biomarkers that were explored. More on the Study The trial enrolled
women with a histologic/cytologic diagnosis of breast cancer, and
evidence of locally recurrent disease or distant metastasis, not
amenable to local therapy. Patients received Alimta (Arm A: 600
mg/m squared; Arm B: 900mg/m squared) on a 21-day cycle, with a
median of six cycles delivered. All patients received folic acid
and vitamin B12 supplementation. Forty-seven patients, aged 33-81
years (with a median age of 57), enrolled in Arm A and 45 in Arm B.
Arm A and B had response rates of 17 percent and 15 percent, median
progression-free survival times of 4.2 and 4.1 months, and median
time-to- tumor progression (TtTP) of 4.2 and 4.6 months,
respectively. Toxicity was mild in both arms (grade 3/4);
neutropenia less than 20 percent; leucopenia less than 9 percent).
(Both neutropenia and leucopenia are related to lowered white blood
cell count.) Non-hematologic side effects were mild and similar to
those commonly experienced when Alimta is used as monotherapy,
e.g., disorders of the blood and lymphatic system, gastrointestinal
disorders, fatigue, rash and desquamation. Primary tumor samples
from 49 patients were assessed for gene expressions. Two markers,
FPGS and TP, showed the most conclusive results. Best response
rates and median TtTP for high vs. low FPGS expression subgroups
were: 37.5 percent vs. 10 percent, and 8.57 vs. 2.99 months. The
results for TP were 27.6 percent vs. 6.2 percent, and 5.39 vs. 1.94
months. About ALIMTA(R) Alimta was first approved by the U.S. Food
and Drug Administration in 2004 for second-line treatment of
non-small cell lung cancer, 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 ALIMTA(R) (pemetrexed),
Lilly This press release contains forward-looking statements about
the potential of Alimta for the treatment of metastatic 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, ; or Martin Blair of CPR
Worldwide, +1-212-453-2349, mobile: +1-646-337-6779,
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