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Eli Lilly and Company

Lung Cancer Patients May Benefit From More Time Without Life-Threatening Chemotherapy Side Effects

Indianapolis, November 1 (ots/PRNewswire)

New data presented
today confirm that advanced lung cancer patients can look forward to
better-quality survival when treated with Alimta(R) (pemetrexed), a
newly approved anticancer agent in the European Union compared with
Taxotere(R) (docetaxel). Eli Lilly and Company announced the results
of this analysis today at the 29th annual European Society for
Medical Oncology meeting in Vienna, Austria.
"Patients suffer from two things, the cancer and chemotherapy side
effects. They do not want to live their lives from doctors' clinics
or hospital beds -- that's what makes these data so meaningful," said
Jean-Louis Pujol, M.D., head of the department of thoracic oncology,
Montpellier Academic Hospital, France. "These results reinforce
Alimta as a major step forward in treating lung cancer patients in
the second-line setting."
The results were gathered from a Phase III global clinical trial
that showed Alimta provided survival comparable to that of Taxotere,
the only other drug approved in this patient population, but with a
more favorable side-effect profile in previously treated patients
with advanced non-small-cell lung cancer.(1) A retrospective analysis
of these data was introduced to measure the toxicity-free survival of
the two therapies. Grade 4 toxicity-free survival time was measured
from the time between a patient's trial enrollment date to the first
recorded date of any Grade 4 toxicity or death. Alimta showed a Grade
4 toxicity-free survival time that was significantly better than
Taxotere (median 7.5 versus 2.3 months, respectively). This means
that patients treated with Alimta benefited from more time without
life-threatening side effects than those treated with Taxotere -- a
three-fold improvement. This difference was statistically
significant.
"Physicians closely monitor for Grade 4 haematological toxicities
when treating advanced lung cancer patients because these side
effects can easily lead to life-threatening events such as infections
or hemorrhages," said Pujol. "It is clear that Alimta offers a
positive perspective on cancer therapy -- challenging the belief that
critical side effects are the 'physical' price that must be paid for
efficacy."
In the study, the main contributor to Grade 4 toxicities was
neutropenia, which is a decrease in infection-fighting white blood
cells that can lead to infection, with 1.9 percent of Alimta patients
versus 31.5 percent of Taxotere patients being affected.
Overall, there were more Grade 4 toxicities in the Taxotere arm,
including febrile neutropenia (0.8 for Alimta versus 2.5 percent for
Taxotere), infections (0 for Alimta versus 1.1 percent for Taxotere),
fatigue (0 for Alimta versus 0.4 percent for Taxotere), painful
breathing or shortness of breath (0 for Alimta versus 0.7 percent for
Taxotere) and pulmonary toxicity (0 for Alimta versus 0.7 percent for
Taxotere). There were two Grade 4 toxicities where Alimta toxicities
were higher: anemia (1.5 for Alimta versus 0 percent for Taxotere)
and Alanine Transaminase (ALT) elevation, a laboratory measurement of
liver function (0.4 Alimta versus 0 percent for Taxotere). The study
also evaluated Grade 3/4 toxicities with similar results. Grade 3
toxicities are those that are severe but not as life threatening as
Grade 4. The Grade 3/4 toxicity-free median survival for Alimta was
1.2 months compared with Taxotere at 0.4 months. This difference was
statistically significant.
In September 2004, Alimta was approved by the European Commission
for two distinct cancer indications. Alimta was approved as a
single-agent therapy for patients with locally advanced or metastatic
non-small cell lung cancer after previous chemotherapy. Alimta was
also approved in combination with cisplatin, a common chemotherapy
agent, for the treatment of malignant pleural mesothelioma, a cancer
in the lining of the lungs, for patients who have not received prior
chemotherapy and are not candidates for surgery. The administration
for Alimta is a convenient 10-minute infusion, once every three
weeks.
Alimta in Non-Small Cell Lung Cancer
According to the 2003 World Health Organization Cancer Report,
lung cancer is the world's most common cancer and the leading cause
of cancer death for both men and women. There will be 1.2 million
cases diagnosed this year around the world.
Alimta was studied in a Phase III global clinical trial involving
571 randomized patients whose non-small cell lung cancer advanced
beyond the first chemotherapy regimen. In this study Alimta and
Taxotere showed similar survival time (median 8.3 versus 7.9 months,
respectively) and progression-free survival (both 2.9 months).(1)
Alimta caused significantly less neutropenia and hospitalization due
to neutropenia with fever, as well as less hair loss compared with
Taxotere. The ALT elevation was higher for Alimta (0.4 Alimta versus
0 percent for Taxotere). When Alimta is given as a single agent, the
most common side effects include disorders of the blood and lymphatic
system, gastrointestinal disorders, fatigue, rash and desquamation
(peeling of the skin). Refer to the Summary of Product
Characteristics (SPC) for complete information on the efficacy and
side-effect profile of Alimta.
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.
This press release contains forward-looking statements about the
potential of Alimta for the treatment of non-small cell lung 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 that the product will prove 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.
Alimta(R) (pemetrexed, Lilly)
Taxotere(R) (docetaxel, Aventis)
(1) Hanna N, Shepherd FA, Fossella FV, et al. Randomized Phase III
Trial of Pemetrexed Versus Docetaxel in Patients with Non-Small Cell
Lung Cancer Previously Treated with Chemotherapy. Journal Clinical
Oncology, Vol. 22, pp. 1589-1597; May 1, 2004.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

Contact:

Carla L. Cox of Lilly, Global, +1-317-457-5602 (mobile),
+1-317-651-1473 (office), or Gregory L. Clarke of Lilly, U.S.,
+1-317-332-5139 (mobile), +1-317-276-5222 (office); Photo: NewsCom:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO , PRN Photo
Desk, photodesk@prnewswire.com

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