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Study Showed ALIMTA(R) (pemetrexed for injection) Improved Survival in Certain Types of Non-Small Cell Lung Cancer

Wednesday, May 28, 2008 General News J E 4
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INDIANAPOLIS, May 28 The type of non-small celllung cancer (NSCLC) patients have may now influence their treatment regimenand, in turn, survival outcome according to the results of a major studypublished online in the Journal of Clinical Oncology. Publication of thestudy was announced by Eli Lilly and Company.

The 1,725-patient study, the largest Phase III clinical trial in thefirst-line NSCLC setting, evaluated ALIMTA(R) (pemetrexed for injection) pluscisplatin versus GEMZAR(R) (gemcitabine HCl for injection) plus cisplatin, astandard of treatment in this setting. The trial met its primary endpoint ofnon-inferiority relative to overall survival.

Additionally, in a pre-planned histological analysis, patients with eitheradenocarcinoma or large-cell carcinoma had a statistically superior andclinically relevant improvement in overall survival when treated with thepemetrexed regimen in the first-line setting.

In comparison, patients with squamous cell histology were found to have amore favorable overall survival when treated with the gemcitabine regimen.

"While non-small cell lung cancer has typically been treated as onedisease, this study confirms that histology, or tumor type, can provide a clueas to which treatment regimen works best for a particular tumor type," saidthe study's lead author, Giorgio Scagliotti, M.D., Department of Clinical andBiological Sciences Thoracic Oncology Unit, University of Torino, Orbassano,Italy. "If we can tailor the therapy for better results, we are closer toimproving outcomes for this terrible disease."

The overall survival of patients treated with either the pemetrexedregimen or gemcitabine regimen was found to be non-inferior, with a mediansurvival of 10.3 months. However, when researchers reviewed survival ratesaccording to histological analysis, it was found that patients withadenocarcinoma achieved 12.6 months of overall median survival when treatedwith the pemetrexed regimen compared to 10.9 months for those treated with thegemcitabine regimen. Patients with large cell carcinoma who were treated withthe pemetrexed regimen achieved 10.4 months of overall median survival versus6.7 months for those treated with the gemcitabine regimen. Both findings arestatistically significant.

Comparatively, patients with squamous cell histology were found to have amore favorable rate of survival when treated with the gemcitabine regimen,achieving 10.8 months of median survival, compared to the 9.4 months for thosetreated with the pemetrexed regimen. This finding also was statisticallysignificant.

The Phase III, randomized study compared the overall survival betweenpemetrexed+cisplatin versus gemcitabine+cisplatin in 1,725 chemonaive patientswith stage IIIB or IV NSCLC who also exhibited a performance status of 0-1.Patients on the pemetrexed arm (n = 862) were treated with pemetrexed (500mg/m2) and cisplatin (75 mg/m2) on day one every three weeks for up to sixcycles. Patients on the gemcitabine arm (n = 863) were treated with cisplatin(75 mg/m2) on day one and gemcitabine (1250 mg/m2) on days one and eight everythree weeks for up to six cycles.

Hematologic grade 3/4 drug-related toxicities - neutropenia, anemia andthrombocytopenia - were significantly lower for patients on the pemetrexed arm(p less than or equal to 0.001). Drug-related grade 3/4 febrile neutropenia(p = 0.002) and alopecia (all grades; p < 0.001) were also significantly lesson the pemetrexed arm. However, drug-related grade 3/4 nausea (p = 0.004) wasmore common in patients treated with pemetrexed. Safety data by histology wasgenerally consistent with the overall safety results.

"In research, we're always looking for a new door to open - a differentway of looking at the problem, in the hope of finding a better solution.That's why this study is so important. It has opened a door that points tohis
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