The primary endpoint was PFS (Progression Free Survival) and the secondary endpoints included safety, ORR (Overall Response Rate), OS (Overall Survival), and PK. Eighty-two eligible patients (ECOG PS 0-1, one prior regimen) were treated with N+I (n = 40) or I (n = 42). Tumor tissues collected from 48 patients (N+I arm: 26, I arm: 22) were analyzed for EGFR and K-ras. EGFR status (0/1+/2+/3+) examined by immunohistochemistry was 44%/25%/13%/17% respectively.
Results: - Median PFS was 73.0 days in the N+I arm compared with 85.0 days in the I arm (HR 0.860; 95% CI, 0.516, 1.435). - Overall Survival was 293.0 days in the N+I arm compared with 227.0 days in the I arm among 82 patients (HR 0.717; 95% CI, 0.420, 1.224). - In the subgroup analyses, the hazard ratio in PFS for patients with EGFR 1+/2+/3+ was 0.463 (95%CI, 0.177, 1.212) and that of EGFR 2+/3+ was 0.341 (95% CI, 0.080, 1.457) and the hazard ratio in OS was 0.584 (95% CI, 0.242, 1.409) and 0.295 (95% CI, 0.077, 1.129), respectively. - The incidence of adverse events was similar between both arms. - No adverse events of grade 3 skin rash or grade 3 infusion-related reactions were reported.
Nimotuzumab is a humanized monoclonal antibody in development worldwide, targeting multiple tumor types primarily in combination with radiation and chemoradiation. It is importantly differentiated from other currently marketed EGFR-targeting agents due to its enhanced side-effect profile. Nimotuzumab's anti-tumor activity has led to its approval for marketing in 25 countries. In more than 10,000 patients reported as having been treated with nimotuzumab worldwide to date, Grade IV incidents of radiation dermatitis and incidents of severe rash have been only rarely observed, and reports of the other severe side-effects that are typical of EGFR-targeting molecules have been equally rare.
|SOURCE YM BioSciences Inc.|
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