The primary endpoint in this study was overall survival. The median survival time was 8.3 months in the ALIMTA treatment arm and 7.9 months in the docetaxel arm, with a hazard ratio of 0.99 (see Table 4). The study did not show an overall survival superiority of ALIMTA. Non-inferiority of ALIMTA to docetaxel could not be demonstrated, because a reliable and consistent survival effect of docetaxel required for a non-inferiority analysis could not be estimated from historical trials. In addition, significant treatment crossover at the time of disease progression may have confounded the survival interpretation. The demonstrated surrogate endpoint, response rate allowed the conclusion that an effect of ALIMTA on survival is reasonably likely.

Exploratory demographic analyses on survival showed no significant differences between ALIMTA and docetaxel in patients over or under 65 years of age. There were too few non-white patients to assess possible ethnic differences. Regarding gender, females lived longer than males in both treatment groups. There was no difference in survival between ALIMTA and docetaxel with respect to gender after adjusting for prognostic factors.

Secondary endpoints evaluated in the trial include objective response rate, progression free survival (PFS) and time to progressive disease (TTPD). There was no statistically significant difference between ALIMTA and docetaxel with respect to objective response rate, progression free survival (PFS) and time to progressive disease (TTPD).

Table 4: Efficacy of ALIMTA vs. Docetaxel in Non-Small Cell Lung Cancer - ITT Population

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