ALIMTA (pemetrexed) and Mesothelioma
Alimta vs. Taxotere -- Similar Survival,
Fewer Side Effects In Recurrent Non-Small Cell Lung Cancer
Business Editors/Health/Medical Writers
CHICAGO--(BUSINESS WIRE)--June 1, 2003--In a head-to-head
trial comparing Alimta(R) (pemetrexed) to Taxotere(R) (docetaxel),
Alimta showed a similar survival benefit with significantly fewer
side effects in patients with recurrent non-small cell lung cancer
(NSCLC). Results of this Phase III trial -- the largest Phase III
trial ever conducted in second-line NSCLC -- were presented today
at the 39th annual meeting of the American Society of Clinical Oncology,
which is being held in Chicago.
"Before Taxotere, we had no agent that was proven to prolong
life for patients with recurrent non-small cell lung cancer,"
said Nasser Hanna, M.D., who presented the findings and is an assistant
professor of medicine at Indiana University Cancer Center. "Now,
with these data on Alimta, we have observed a survival advantage,
just as we have with Taxotere, but with fewer side effects."
Today's announcement was based on a global study of 571 patients
with NSCLC previously treated with chemotherapy. Of these patients,
283 were randomized to receive Taxotere (75 mg/m2 on day one of
a 21-day cycle; one-hour infusion). The remaining 288 patients received
Alimta (500 mg/m2 on day one of a 21-day cycle; 10-minute infusion)
supplemented with vitamin B12 and folic acid. Unlike Alimta, which
is an investigational agent, Taxotere is approved for use in the
treatment of first- and second-line NSCLC in both the U.S. and Europe.
According to the results:
- Median survival, the study's primary
endpoint, was similar between the two study arms. Those
receiving Alimta had a median survival of 8.3 months, which
means that half of the patients survived longer than 8.3
months and half shorter. The median survival for those who
received Taxotere in this study was 7.9 months.
- The incidence of severe neutropenia,
a decrease in the number of white blood cells that increases
the risk of infection, was 5 percent in the Alimta arm and
40 percent in the Taxotere arm, a difference that was statistically
significant (p= less than 0.001).
- The difference in the incidence of
neutropenic fever and subsequent hospitalizations between
the Alimta and Taxotere arms was also statistically significant:
2 percent for the Alimta patients compared to 13 percent
for the Taxotere patients (p= less than 0.001).
- In a third finding that reached statistical
significance, the incidence of drug-related serious adverse
events -- which include side effects that could lead to
a life-threatening outcome, death or hospitalization --
was 10 percent for Alimta patients and 24 percent for Taxotere
patients (p= less than 0.001).
- The incidence of grades 3/4 Alanine
Transaminase (Alanine Transaminase, or ALT, is a laboratory
measurement of liver function) was 1.9 percent in the Alimta
arm, a rate that was significantly greater than in the Taxotere
arm (p=0.028). According to the findings, the incidence
of grades 3/4 ALT in the Alimta arm was transient.
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"Patients with cancer who are being treated in the second-line
setting must heavily consider the risk-benefit ratio of another
course of chemotherapy. It can be a difficult balancing act, but
in this study, patients who received Alimta retained the chance
of a benefit, but with fewer side effects, and that is important,"
said Paolo Paoletti, M.D., vice president of oncology products at
Eli Lilly and Company. He added that Lilly is also evaluating the
activity of Alimta in the first-line treatment of NSCLC.
Alimta in First-Line NSCLC
At this year's ASCO meeting, the following abstracts are being presented
involving the use of Alimta in the first-line treatment of advanced
NSCLC:
- Alimta plus carboplatin in patients with advanced non-small
cell lung cancer: A phase II trial (Abstract #2580)
- Phase II randomized study of pemetrexed + carboplatin
or
oxaliplatin, as front-line chemotherapy in patients with
locally advanced or metastatic non-small cell lung cancer
(Abstract #2513)
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"Alimta has already shown promising activity when combined
with cisplatin in malignant pleural mesothelioma, a difficult-to-treat
cancer in the lining of the lungs, and today's data support use
with platinum compounds for non-small cell lung cancer," said
Christian Manegold, professor of medicine at the University of Heidelberg,
and consultant for medical oncology at the Thoracic Hospital in
Heidelberg, Germany. "These findings are especially meaningful
in Europe where platinum regimens provide feasible alternatives
so patients may receive treatment on an outpatient basis. With their
ease of use, Alimta combinations could provide attractive and convenient
choices for these patients suffering from non-small cell lung cancer."
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