Alimta(R) Showed Advances over Taxotere(R) in Second-Line Non-Small Cell Lung Cancer Study

Alimta(R) Showed Advances over Taxotere(R) in Second-Line
Non-Small Cell Lung Cancer Study 


INDIANAPOLIS, May 3  /PRNewswire-FirstCall/ -- In a recent study, Lilly's drug
Alimta(R) (pemetrexed) demonstrated a similar patient survival rate, but with
an improved safety profile, when compared to Taxotere(R) (docetaxel), the
current standard of care for second-line non-small cell lung cancer.

The research findings of the largest head-to-head Phase III trial ever reported
to date in second-line non-small cell lung cancer were reported in the May 1
issue of the Journal of Clinical Oncology(1), a peer-reviewed journal.

Alimta, in combination with cisplatin, was recently approved by the FDA for use
in the treatment of malignant pleural mesothelioma, a cancer often associated
with asbestos exposure.

Currently, Taxotere is the only drug approved in the U.S. to treat patients
with non-small cell lung cancer in the second line setting.  While the drug
extends the average patient's life by a few months when compared to best
supportive care, it is associated with several side effects, including hair
loss and blood-related toxicities, including neutropenia, a lowering of the
white blood cell count that can cause infections and fever, thus requiring
hospitalization.

The new findings show that Alimta, which can be administered in 10 to 15 minute
infusions once every three weeks, displayed a survival rate comparable to that
of Taxotere (median survival was 8.3 months vs. 7.9 months respectively), but
with fewer serious side effects.

"Alimta clearly had fewer drug-related hematological side effects, which
resulted in fewer hospitalizations," said Nasser Hanna, M.D., lead author of
the study and assistant professor, Indiana University School of Medicine and
member of the Indiana University Cancer Center.  "So in short, Alimta is better
tolerated, it's convenient to administer and it's equally as effective as
Taxotere."  Patients on Alimta did show an increased transient elevation in the
liver enzyme, Alanine Transaminase (ALT) said Hanna.

Lilly has submitted a New Drug Application to the Food and Drug Administration
for the use of Alimta in the second-line treatment of non-small cell lung
cancer.  Lilly anticipates a regulatory decision by the fourth quarter.  Lilly
has also submitted a dual European submission, with the first part for Alimta,
combined with cisplatin, in the treatment of malignant pleural mesothelioma and
the second for Alimta as a single-agent in the second-line treatment of
non-small cell lung cancer.

"We commend the scientists in this study for their commitment to conducting
quality research in an effort to support patients and physicians who are
affected by this devastating disease," said Paolo Paoletti, M.D.,
vice-president of clinical research, oncology products, Eli Lilly and Company.
"Importantly, this was a study in which Alimta was compared to the standard of
care in the treatment of second-line non-small cell lung cancer and the results
were similar efficacy and less blood-related toxicity for Alimta."

Study Design

The Phase III global study involved 571 randomized patients whose non- small
cell lung cancer advanced beyond the first chemotherapy regimen.  Among the
patients enrolled in this study, 283 received Taxotere (75 mg/m2 on day one of
a 21-day cycle; one-hour infusion) and 288 received Alimta (500 mg/m2 on day
one of a 21-day cycle; 10-minute infusion; supplemented with vitamin B12 and
folic acid).  The primary endpoint was overall survival and secondary endpoints
included toxicity, response rate, and progression-free survival.

   Key study findings are as follows:

                              Alimta (n=265)  Taxotere (n=276)     p-value

   Median Survival Time        8.3 months       7.9 months           NS
                                                                   (non
                                                               statistically
                                                                significant)

   Overall Response Rates      9.1 percent      8.8 percent          NS
                                                                   (non
                                                               statistically
                                                                significant)

   Grade 3 or 4 Neutropenia    5.3 percent     40.2 percent