Updated Analysis in Second-Line Treatment of Lung Cancer Trial Confirms Similar Survival for Alimta(R) and Docetaxel
04 June 2006 - 11:00PM
PR Newswire (US)
Alimta Also Shows Tolerability as Triplet Combination Treatment in
First-Line Lung Cancer ATLANTA, June 4 /PRNewswire-FirstCall/ --
Data presented today at the 42nd American Society of Clinical
Oncology (ASCO) annual meeting in Atlanta, Ga., affirms that
ALIMTA(R) (pemetrexed), manufactured and marketed by Eli Lilly and
Company, offers patients with advanced non-small cell lung cancer
(NSCLC) similar overall survival as docetaxel (Taxotere(R)). The
survival data were part of a large (n=571), randomized Phase III
study to evaluate the efficacy and safety profile of Alimta as
second-line therapy in NSCLC. First reported in 2003(i), the study
found that patients in the Alimta arm achieved 8.3 months of median
survival, whereas those in the docetaxel arm obtained 7.9 months.
This updated analysis of data tracked patients from the same study
nearly two years beyond the conclusion of the original study and
found similar results. The updated data showed that patients who
received Alimta experienced 8.3 months of median survival compared
to 8.0 months for those in the docetaxel arm. "The data mirror
previously reported results and confirm the efficacy of Alimta
versus docetaxel," said Filippo de Marinis, M.D., director of the
Pulmonary-Oncology Unit at San Camillo-Forlanini High
Specialization Hospitals in Rome, Italy, and one of the study's
principal investigators. "Based on these data, and on its safety
advantage, Alimta should be regarded as a standard of care for
non-small cell lung cancer patients in the second-line setting."
Patients in both arms of the trial were given standard doses of
therapy for NSCLC. On day one of a 21-day cycle, patients in the
Alimta arm of the trial received Alimta (500 mg/m squared), which
was supplemented with vitamin B12 and folic acid as per label
instructions. A team of researchers led by Lilly discovered that
this vitamin supplementation given with Alimta significantly
reduces the frequency and severity of the drug's side effects
without compromising its ability to kill cancer cells. Patients in
the docetaxel arm were given a 75 mg/m squared infusion. As
previously reported, the incidence of severe neutropenia, a
decrease in the number of white blood cells that increases the risk
of infection, was five percent in the Alimta arm and 40 percent in
the docetaxel arm, an eight-fold difference that was statistically
significant (p=