red with 906 Caucasians. The trial was designed to compare the efficacy of GEMZAR plus carboplatin with GEMZAR plus paclitaxel and a reference regimen of carboplatin plus paclitaxel. Data from all three arms were pooled for this analysis. Overall survival, the primary endpoint, on the African-American arm was 8.7 months compared to 8.1 months in the Caucasian arm, which was not significantly different. African-Americans demonstrated slightly lower incidences of grade 3/4 toxicities (constitutional, hemorrhagic and metabolic).
The ALIMTA study reviewed a post-hoc analysis of pooled data from six previous trials, including one Phase III in a second-line setting and five Phase II trials in a first-line setting. Patients with Stage IIIB/IV NSCLC were given at least one dose of ALIMTA (single-agent or in combination with other treatments) every 21 days. The trial evaluated results from 411 Caucasian patients compared with 117 non-Caucasian (African-American, Asian and Hispanic) patients. Based on this analysis, race did not have a statistically significant impact on efficacy parameters (response rate, survival and disease control rate). Non-Caucasian patients had lower grade 3/4 toxicities, including neutropenia (a decrease in white blood cells); anemia (a decrease in red blood cells); fatigue; and nausea.
At the very least, the data unveiled today suggests that we should continue actively studying the impact of our medications on a diverse number of populations, said Dr. Obasaju.
To that end, Lilly recently began enrollment into what may be the largest and most diverse Phase III study in NSCLC. The study will evaluate ALIMTA in 1,000 patients with NSCLC. Enrollment will include 200 African-Americans, 200 Asians, 200 Hispanics and 400 Caucasians. For more information on this trial visit www.lillytrials.com or www.clinicaltrials.gov.
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Contact: Neil Hochman
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