Alimta Continues To Show Versatility in Treating Different Cancers

     
BW20021021002870  20021022T060114Z UTC


( BW)(ELI-LILLY-&-CO)(BC43) Alimta Continues To Show Versatility in
Treating Different Cancers

    Business Editors
    UK REGULATORY NEWS

    INDIANAPOLIS--(BUSINESS WIRE)--Oct. 22, 2002--

Alimta(R) (pemetrexed), when combined with cisplatin, is emerging as a
promising new treatment option for malignant pleural mesothelioma
(MPM) as a result of a Phase III trial presented earlier this year. An
investigational compound, Alimta, may also be active in treating lung
cancer, according to the results of several new Phase I and II
studies.

"New data continue to show that Alimta produces promising results
either as a single or combination agent across tumour types," said Dr.
Frances Shepherd, professor of medicine, University of Toronto, Scott
Taylor Chair in Lung Cancer Research, Princess Margaret Hospital,
Toronto, Ontario, Canada. "The data gathered thus far have prompted us
to extend the scope of Alimta studies across cancers, regimens and
drug combinations. We are very excited about the development of this
drug and look forward to realizing its potential," said Shepherd, who
is also president-elect of the International Association for the Study
of Lung Cancer.

Alimta, when studied with both cisplatin and carboplatin, has shown
promising results. In a Phase II study combining Alimta with cisplatin
in patients with non-small-cell lung cancer, the combination
demonstrated 8.9 months median survival and a 44.8 percent response
rate.

Eli Lilly and Company sponsored new studies presented at the 27th
European Society for Medical Oncology (ESMO) Congress in Nice, France,
which build on these consistent results.

Study Results from Alimta/Gemzar(R) in NSCLC

Data were presented from a Phase II trial of Alimta combined with
Gemzar(R) (gemcitabine HCl), in patients with advanced non-small-cell
lung cancer (NSCLC). Gemzar is already a standard of care worldwide
for pancreas cancer and is also the standard of care in many parts of
the world for NSCLC and bladder cancers.

The platinum-free combination of Alimta and Gemzar produced a median
survival of 11.3 months and a median time to progression of 4.9
months. The time to event measures were encouraging. Both drugs have
produced response rates in the range of 20 percent when they have been
studied as single agents. In addition, 50 percent had disease
stabilization and 44 percent of the patients were alive one year after
enrolling in the study.

The most common hematologic side effect was neutropenia (a decrease in
white blood cells), which occurred in 34 percent of the patients. The
most common nonhematologic side effect was elevated AST/ALT (aspartate
amino transferase/ amino alanine transferase - enzymes monitored to
assess liver function) occurring in 21 percent of patients. Patients
in this study received dietary amounts of folic acid and vitamin B12
supplementation.

Investigators also gathered data on improvement or stability of
disease-related symptoms, which showed improvement/stability of
anorexia, cough, dyspnea (difficult, painful breathing or shortness of
breath) and pain.

Overall, the study investigators concluded that Alimta/Gemzar should
be studied further in advanced NSCLC based on the encouraging survival
results and symptom benefits.

"The preliminary results seen in the Alimta/Gemzar study confirmed the
potential strength of Alimta," said Paolo Paoletti, M.D., vice
president medical - oncology, Eli Lilly and Company, "The possibility
of offering a nonplatinum combination in NSCLC patients may be an
important alternative for treatment of this disease, especially
considering the easy-to-control toxicity profile of Alimta. We
certainly look forward to examining the therapeutic profile of Alimta
in upcoming studies."

A Phase III study comparing Alimta with Taxotere(R) (docetaxel) in
second-line chemotherapy has been fully enrolled and is awaiting final
analysis and dissemination of the results.

Study Results from Clinical Benefit Algorithm for Mesothelioma

Study results presented in May 2002 at the American Society of
Clinical Oncology (ASCO) demonstrated that a combination of Alimta and
cisplatin has high efficacy in tumour reduction and enables people
with malignant pleural mesothelioma (MPM) to live longer. New data
from that same study also demonstrates Alimta/cisplatin has an impact
on disease-related symptoms as measured by a composite endpoint called
clinical benefit response. Clinical benefit response is an objective
clinical measure of symptom improvement that, in this study, was based
on pain (intensity and analgesic consumption), dyspnea and performance
status.

Clinical benefit parameters were rated after each three-week cycle of
treatment and were compared with baseline values. A clinical benefit
responder was defined as any patient who demonstrated sustained
improvement after at least two cycles of treatment in at least one
parameter and in absence of deterioration in any other parameter.

Of the 368 patients evaluable for clinical benefit response, 21
percent of the Alimta/cisplatin patients and 14 percent of cisplatin
patients were considered responders. The Alimta/cisplatin regimen also
showed a greater improvement in dyspnea (15 versus 8 patients) and
pain intensity (22 versus 10 patients).

As presented at ASCO, median survival was 12.1 months for
Alimta/cisplatin, versus 9.3 months for cisplatin alone, with an
overall tumor response rate of 41 percent versus 17 percent with
cisplatin alone. These results combined with those released today
demonstrate a real advance in the treatment of this notoriously
hard-to-treat cancer.

Results from Alimta/Navelbine(R) in a Phase I/II Trial

Preliminary data from a Phase I/II study of Alimta and Navelbine
(vinorelbine) (a commonly used antineoplastic therapy) were presented
today. The Phase I portion of the study established the dosing
regimen. Results from the ongoing Phase II portion of this study,
which has enrolled only advanced NSCLC patients with no prior
chemotherapy, showed promising antitumour activity.

Lilly, a leading innovation-driven corporation is developing a growing
portfolio of 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.
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*T
Alimta(R) (pemetrexed, Lilly)
Gemzar(R) (gemcitabine hydrochloride, Lilly)
Navelbine(R) (vinorelbine, Glaxo SmithKline)
Taxotere(R) (docetaxol, Aventis Pharmaceuticals, Inc.)
*T

   Short Name: Lilly (Eli) & Co.
   Category Code: MSC
   Sequence Number: 00001015
   Time of Receipt (offset from UTC): 20021015T194521+0100

    --30--jgm/in 

    CONTACT: Lilly Global
             Carla L. Cox, 317/651-1473 
             [phone] - (on-site at ESMO)
                     or
             CPR Worldwide
             Catalina Asanza, 212/583-9290 

    KEYWORD: INDIANA FRANCE UNITED KINGDOM INTERNATIONAL EUROPE 
    INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL
    SOURCE: Lilly (Eli) & Co

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