Combining Innovative Therapies for Optimal Cancer Care; Effectiveness of Gemzar-Based Combination Regimens is Topic of Workshop

     
BW20021017002700  20021018T060036Z UTC


( BW)(ELI-LILLY-&-CO)(BC43) Combining Innovative Therapies for Optimal
Cancer Care; Effectiveness of Gemzar-Based Combination Regimens is
Topic of Workshop

    Business Editors
    UK REGULATORY NEWS     

    INDIANAPOLIS--(BUSINESS WIRE)--Oct. 18, 2002-- 

The Power of the Combination Journalist Workshop European Society for
                   Medical Oncology (ESMO) Congress

Combination therapy is increasingly becoming the cornerstone for
cancer treatment, offering patients improved survival without
compromising tolerability, as compared with single-agent therapies.
Clinical data reinforce that combination regimens are shaping the
future of cancer care and will continue to be the focus of research
and development in oncology.

Gemzar(R) (gemcitabine HCl), manufactured by Eli Lilly and Company, is
commonly used as the basis of combination regimens because of its
broad antitumour activity and potential to enhance and complement
other agents. This consistency in activity has been demonstrated in
more than 25 randomized Phase III clinical trials published to date in
non-small-cell lung cancer.

Gemzar-based combination regimens and data from Phase III trials will
be the topic of discussion at a journalist workshop, The Power of the
Combination, during this week's 27th European Society for Medical
Oncology (ESMO) Congress in Nice, France.

"One of the major goals of research and development today is
transforming cancer from an acute disease to one that is chronic and
manageable," said Dr. Christian Manegold, professor of medicine,
University of Heidelberg Thoraxklinik-Heidelberg GmbH, Germany.
"Combination cancer therapy will play an important role in realizing
this ambitious paradigm shift. Data gathered from clinical trials
combining Gemzar with other specific chemotherapy agents and novel
compounds, show consistent tumour responses, with an attractive
tolerability and safety profile. For this reason, Gemzar/cisplatin is
often the platform for development for many new biologicals, not only
within Lilly's oncology pipeline, but also with therapies being
developed by other major pharmaceutical companies."

Gemzar is currently being evaluated in combination with a variety of
other therapies, including:
-0-
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-- Taxanes - Taxol(R), Taxotere(R)

-- Platinums - carboplatin, cisplatin

-- Antimetabolites- Alimta(R)

-- Anthracyclines- doxorubicin, epirubicin

-- Vinca-alkaloids- Navelbine(R)

-- Targeted/Novel agents- Affinitac(TM), Iressa(R), Herceptin(R),
   Tarceva(R), Erbitux(R), LY317615 (a PKC-beta inhibitor)
*T

The purpose of these studies, which are being conducted in multiple
cancers (pancreas, lymphomas, bladder, breast, ovarian, non-small-cell
lung), is to optimise patient outcomes by offering improvement in both
efficacy and safety.

During the workshop, speakers will also review a variety of data
gathered from Gemzar-based combination trials, including data from a
Phase III trial presented at the American Society of Clinical Oncology
(ASCO) in May 2002 comparing Gemzar plus carboplatin with mitomycin,
ifosfamide and cisplatin (MIC) in advanced non-small-cell lung cancer
(NSCLC). The Gemzar/carboplatin doublet extended median survival by
more than three months when compared with this three-drug regimen. MIC
is a commonly used treatment in Europe for NSCLC.

Study Results

This Phase III randomized study of 422 advanced NSCLC patients
compared survival and quality-of-life benefits of a Gemzar and
carboplatin regimen with MIC. The Gemzar/carboplatin combination
results indicate a significant median survival advantage - 10.2 months
versus 6.9 months - and substantially lower incidence of nausea,
vomiting, hair loss and constipation and improved quality of life
compared with the MIC regimen. Fewer hospital admissions were required
for patients treated with Gemzar/carboplatin than for those treated
with MIC (14 percent versus 89 percent), which provided a substantial
cost benefit. The results suggest that the Gemzar/carboplatin regimen
is associated with longer survival than MIC and offers less toxicity.

An additional multicenter, randomized Phase III study presented at
ASCO compared single-agent Gemzar with Gemzar plus carboplatin in 334
randomized patients with advanced NSCLC. The primary objective of the
study was to evaluate overall survival. Secondary objectives include
response rate, time to disease progression and toxicity. Study results
indicated that patients on the Gemzar/carboplatin arm had a more than
doubled objective response rate (30 percent versus 12 percent) and a
significantly extended time to disease progression (six versus four
months). Median survival for the Gemzar/carboplatin group was 10
months compared with 9 months in single agent Gemzar. Although not
clinically significant, the most common side effect was
thrombocytopenia (a decrease in the number of platelets).

"It is critical that physicians choose the right chemotherapy
`partner' in order to maximize treatment outcomes and benefits for
their cancer patients," said Jorge Otero, M.D., medical director of
the Gemzar global product team at Lilly. "When operating as part of a
doublet, Gemzar shows consistently high activity. Reliable efficacy
and tolerability have made Gemzar the cornerstone of Lilly's oncology
franchise. We are committed to taking part in continued clinical
research with a variety of other products to provide physicians with
the best regimens with which to combat this terrible disease."

Gemzar in Combination Therapies

The global cancer-research community has made the Gemzar molecule
among the most widely studied oncology agents in recent years. Gemzar
is approved in more than 90 countries. It is the standard of care
worldwide for pancreatic cancer. Gemzar is also the standard of care
in many parts of the world for non-small-cell lung and bladder
cancers.

Gemzar is a nucleoside analogue that interferes with the processes of
DNA production; by doing so, Gemzar prevents cancer cells from
replicating and thus slows or stops tumour growth.

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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Affinitac(TM)(LY900003, Lilly)
Alimta(R)(pemetrexed, Lilly)
Erbitux(R)(IMC-C225, Imclone)
Gemzar(R)(gemcitabine hydrochloride, Lilly)
Herceptin(R)(trastuzumab, Genentech)
Iressa(R) (ZD1839, AstraZeneca)
LY317615 (a PKC-beta inhibitor, Lilly)
Navelbine(R) (vinorelbine, Glaxo SmithKline)
Tarceva(R)(erlotinib, OSI Pharmaceuticals)
Taxol(R) (paclitaxel, Bristol-Myers Squibb Oncology/Immunology)
Taxotere(R) (docetaxol, Aventis Pharmaceuticals, Inc.)
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   Short Name: Lilly (Eli) & Co
   Category Code: MSC
   Sequence Number: 00000996
   Time of Receipt (offset from UTC): 20021015T201145+0100

    --30--jgm/in 

    CONTACT: Lilly Global
             Carla L. Cox, 317/651-1473 
             +44 77985 88755 - (on-site at ESMO)
                     or
             CPR Worldwide
             Paul George, +44 20728 21200 
             Catalina Asanza, 212/583-9290 

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

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