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2025'02.26.Wed
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2007'09.08.Sat
Data Affirm Benefit of ALIMTA(R) (pemetrexed for injection) for Patients With Malignant Pleural Mesothelioma
September 05, 2007



ALIMTA-based Regimens Continue to Support Patients with
Devastating Disease


    SEOUL, South Korea, Sept. 5 /Xinhua-PRNewswire/ -- Data
from two large, open-label studies show patients experienced
one-year survival rates above 50 per-cent when treated with
ALIMTA(R) (pemetrexed for injection) or ALIMTA-based
regimens for malignant pleural mesothelioma (MPM) in both a
first-line and second-line setting.  The study results
affirm important efficacy and safety benefits for Eli Lilly
and Company's ALIMTA, the only-known agent to demon-strate a
survival benefit in this often difficult-to-treat disease
primarily associated with exposure to asbestos.  The data
were presented today at the 12th World Conference on Lung
Cancer. 

    ( Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

    One of the largest studies undertaken in the treatment
of mesothelioma, the triple-arm, open-label, multicenter,
first-line study (WCLC Abstract # C5-01) treated patients
with ALIMTA as a single agent, while the other two arms
evaluated ALIMTA in combination with either cisplatin or
carboplatin.  All three arms demonstrated clinically
similar one-year survival rates (58.6% for ALIMTA alone;
63.1% for ALIMTA+cisplatin, and; 64.0% for
ALIMTA+carboplatin).  The ALIMTA plus platinum combination
arms achieved higher response rates than ALIMTA alone
(10.5% for ALIMTA; 26.3% for ALIMTA+cisplatin, and; 21.7%
for ALIMTA+carboplatin).  All 2,023 patients treated in the
first-line setting had a histologic or cytologic diagnosis
(pa-tients cells were reviewed under a microscope) of MPM
that was not amenable to curative surgery.
  
    An open-label, multicenter study (WCLC Abstract #
C5-03), evaluated the results from 988 patients who were
treated in a second-line setting for MPM with ALIMTA as a
single agent, ALIMTA+cisplatin or ALIMTA+carboplatin after
being previously treated with chemotherapy.  All three arms
demonstrated a significant one-year survival rate (54.7% for
ALIMTA alone; 67.9% for ALIMTA+cisplatin, and; 65.5% for
ALIMTA+carboplatin).  Patients treated with ALIMTA in
combination with a platinum-based chemotherapy demonstrated
higher response rates (12.1% for ALIMTA; 23.8% for
ALIMTA+cisplatin, and; 16.8% for ALIMTA+carboplatin).  The
most common grade 3/4 toxicities on both studies were
leukopenia, neutropenia, thrombocytopenia and anemia. 

    "The initial clinical trial results for ALIMTA in
malignant pleural mesothelioma were definitely considered a
medical breakthrough when they were unveiled just three
years ago," said Richard Gaynor, M.D., vice president,
cancer research and global oncology platform leader for
Lilly.  "It is encouraging that these open-label
studies show real world patient treatment outcomes that are
consistent with those from the controlled clinical research
environment.  In my opinion, this is clinically meaningful
information to the practicing oncologist."

    ALIMTA was approved by both the European Medicines
Agency (EMEA) and the U.S. Food and Drug Administration
(FDA) in 2004 in combination with cisplatin for the
treatment of MPM.  To date, ALIMTA has been approved in
more than 85 countries in combination with cisplatin for
the treatment of MPM. 

    Mesothelioma

    Malignant pleural mesothelioma is a rare cancer of the
lining of the lungs.  The disease is often associated with
asbestos exposure and has a long latency period -- usually
between 20 and 40 years.  Most people are not diag-nosed
until the cancer is in advanced stages and treatment with
surgery or ra-diation is not an option.  

    ALIMTA ABBREVIATED PRESCRIBING INFORMATION

    Uses

    ALIMTA is indicated in combination with cisplatin for
the treatment of chemotherapy naive patients with
unresectable malignant pleural mesothelioma.  ALIMTA is
indicated as monotherapy for the treatment of patients with
locally advanced or metastatic non-small cell lung cancer,
after prior chemotherapy.

    Dosage and Administration

    The drug is to be administered intravenously, under the
supervision of a physician qualified in the use of cytotoxic
anti-cancer therapy.

    Malignant pleural mesothelioma: Pemetrexed in
combination with cisplatin has been investigated using a
three-week (21-day) cycle.  Pemetrexed is used at 500 mg/m2
of body surface area (BSA), given by ten-minute infusion, on
day 1 of each 21-day cycle. Cisplatin is used at 75 mg/m2
BSA, given by two-hour infusion, approximately 30 minutes
after completion of the pemetrexed infusion on day 1 of
each cycle.  Adequate anti-emetic treatment and hydration
for cis-platin treatment must be given.

    Non-small cell lung cancer: The recommended dose of
pemetrexed is 500 mg/m2 BSA, given by ten-minute infusion,
on day 1 of each 21-day cycle.

    Pre-medication: Supplement with 1000 micrograms
intramuscular vitamin B12 and oral folic acid (350 to 1000
micrograms) to reduce toxicity (for full de-tails see
Summary of Product Characteristics [SPC]).  To reduce the
incidence and severity of skin reactions, a corticosteroid
should be given the day prior to, on the day of, and the
day after pemetrexed administration -- this should be
equivalent to 4mg of dexamethasone administered orally
twice a day.

    Monitoring: Monitor prior to each dose for complete
blood cell count, in-cluding a differential white cell
count and platelet count.  Absolute neutro-phil count
should be greater than or equal to 1,500 cells/mm3 and
platelets greater than or equal to 100,000 cells/mm3. 
Prior to each dose, collect blood chemistry tests to
evaluate renal and hepatic function.  Dose adjustments to
pemetrexed and/or cisplatin at the start of a subsequent
cycle should be based on nadir haematological counts or
maximum non-haematological toxicity.  If necessary, delay
or withhold treatment in the presence of haematological
tox-icity, neurotoxicity, and/or impaired hepatic/renal
function.  (For full in-formation on dose modification see
SPC.)

    Children and adolescents: Not recommended for use in
patients under 18 years of age.

    Renal impairment: Patients with creatinine clearance
greater than or equal to 45 ml/min require no dose
adjustment other than those recommended for all patients. 
Use in patients with creatinine clearance below 45 ml/min
is not recommended.  See also Warnings and Special
Precautions.

    Hepatic impairment: Patients with hepatic impairment,
such as bilirubin >1.5-times the upper limit of normal
and/or transaminase >3.0-times the upper limit of normal
(hepatic metastases absent) or >5.0-times the upper limit
of normal (hepatic metastases present), have not been
specifically studied.

    Contra-indications

    Hypersensitivity to pemetrexed or to any of the
excipients.  Concomitant yellow fever vaccine. 
Breast-feeding.

    Warnings and Special Precautions

    Myelosuppression is usually the dose-limiting toxicity.
 Patients must be instructed to take folic acid and vitamin
B12 as a prophylactic measure.  Pre-treatment with
dexamethasone (or equivalent) can reduce the incidence and
se-verity of skin reactions. Serious renal events,
including acute renal failure, have been reported with
pemetrexed alone or in combination with other
chemo-therapeutic agents.  Many of the patients in whom
these occurred had underly-ing risk factors including
dehydration or pre-existing hypertension or diabe-tes.  In
patients with clinically significant third space fluid,
consideration should be given to draining the effusion
prior to administration.  Serious cardiovascular events,
including myocardial infarction and cerebrovascular events,
have been uncommonly reported when pemetrexed is given in
combination with other cytotoxic agents; most of these
patients had pre-existing cardio-vascular risk. 
Concomitant use of live attenuated vaccines is not
recom-mended.

    Interactions

    Concomitant administration of nephrotoxic drugs and
substances that are also tubularly secreted could
potentially result in delayed clearance of pe-metrexed.  If
necessary, creatinine clearance should be closely monitored.
 Patients must avoid taking non-steroidal anti-inflammatory
drugs (NSAIDs) with long elimination half-lives for at
least 5 days prior to, on the day, and at least 2 days
following pemetrexed administration.  In patients with
normal re-nal function (creatinine clearance greater than
or equal to 80 ml/min), high doses of NSAIDs (such as
ibuprofen >1600 mg/day) and aspirin at higher dosage
(greater than or equal to 1.3 g daily) may decrease
pemetrexed elimination and increase the occurrence of
adverse events.  Patients with mild to moderate re-nal
insufficiency (creatinine clearance from 49 to 79 ml/min)
should avoid taking NSAIDs (e.g., ibuprofen) or aspirin at
higher dosage, for 2 days be-fore, on the day of, and 2
days following pemetrexed administration.
    There is a possible interaction between oral
anticoagulants and pe-metrexed; therefore, increase the
frequency of International Normalised Ratio monitoring
(INR) if treating with oral anticoagulants.

    Pregnancy and Lactation

    Avoid in pregnancy and do not use in breast-feeding
women.

    Pemetrexed can be genotoxic; sexually mature males are
advised not to fa-ther a child during treatment and up to 6
months thereafter.  Owing to the possibility of irreversible
infertility, men are advised to seek counselling on sperm
storage before starting treatment.  Women of childbearing
potential must use effective contraception during
treatment.

    Driving, etc

    It has been reported that pemetrexed can cause
somnolence.  Patients should be cautioned against driving
or operating machinery.

    Undesirable Effects

    Haematological: Very common: Anaemia, leucopenia,
thrombocytopenia, neu-tropenia.  Common: Febrile
neutropenia and infection without neutropenia.  Un-common:
Pancytopenia.

    Gastro-intestinal: Very common: Nausea, vomiting,
stomatitis/pharyngitis, anorexia, diarrhoea, constipation. 
Common: Dyspepsia, abdominal pain.  Rare: Colitis.

    General: Very common: Fatigue.  Common: Fever,
conjunctivitis.

    Metabolism and nutrition: Common: Dehydration.

    Nervous system: Very common: Neuropathy - sensory. 
Common: Neuropathy - motor, dysgeusia.

    Renal and urinary: Very common: Creatinine elevation,
creatinine clearance decreased.  Common: Renal failure.

    Hepatobiliary: Common: SGPT (ALT) elevation and SGOT
(AST) elevation, in-creased GGT.  Rare: Cases of hepatitis,
potentially serious, have been re-ported during trials.

    Skin and subcutaneous tissue: Very common:
Rash/desquamation, alopecia.  Common: Urticaria, allergic
reaction/hypersensitivity, erythema multiforme, pruritus.

    Cardiovascular and cerebrovascular: Uncommon:
Myocardial infarction, an-gina pectoris, cerebrovascular
accident, arrhythmias, transient ischaemic at-tack. 
(Usually when given in combination with other cytotoxic
agents and with pre-existing cardiovascular risk.)  Common:
Chest pain.

    For full details of these and other side-effects,
please see the Summary of Product Characteristics, which is
available at http://emc.medicines.org.uk/ .

    About 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 pro-grams to patients and
their physicians. Inspired by 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.  

    About 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 ap-plying the
latest research from its own worldwide laboratories and
from col-laborations with eminent scientific organizations.
Headquartered in Indianapo-lis, Ind., Lilly provides answers
-- through medicines and information -- for some of the
world's most urgent medical needs. 

    P-LLY

    ALIMTA(R) (pemetrexed for injection), Lilly

    This press release contains forward-looking statements
about the potential of ALIMTA for the treatment of
malignant pleural mesothelioma and reflects Lilly's current
beliefs.  However, as with any pharmaceutical products under
development, there are substantial risks and uncertainties
in the process of development, commercialization, and
regulatory review.  There is no guarantee that the products
will receive additional regulatory approvals. There is also
no guarantee that the products 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
un-dertakes no duty to update forward-looking statements.



    For more information, please contact:

     Gregory L. Clarke, Lilly
     Mobile: +1-317-554-7119
     Email:  gregory.clarke@lilly.com

     Chantal Samonte
     CPR Worldwide
     Mobile: +1-202-550-4129
     Email:  c.samonte@cprworldwideusa.com
PR
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