Phase II study of nimotuzumab a humanized monoclo

Authors: Dirk Strumberg Beate Schultheis M E Scheulen R A Hilger J Krauss N Marschner F Lordick F Bach D Reuter L Edler K Mross

Publish Date: 2010/12/21

Volume: 30, Issue: 3, Pages: 1138-1143

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Abstract

Introduction Nimotuzumab is a humanized monoclonal antibody that binds to the EGFR Based on phase I data the recommended dose has been established at 200 mg weekly This study was aimed at evaluating the safety and efficacy of nimotuzumab monotherapy in patients pts with locally advanced or metastatic pancreatic cancer Methods Pts who failed first line standard chemotherapy for advanced disease and had at least one measurable lesion were eligible for the study Nimotuzumab was given intravenously at 200 mg once weekly for 6 weeks wks Follow up by CT scan was performed after 8 weeks Pts continued receiving treatment 3weekly until disease progression or unacceptable toxicity occurred Endpoints included tumor response RECIST progressionfree survival PFS and safety Results A total of 56 pts were enrolled for treatment ECOG status of 1 n = 41 or 0 n = 15 the majority 47 pts had metastatic disease Nearly half of the pts n = 26 received ≥2 regimens Pts evaluable for response n = 36 CR 0 PR 0 SD 6 pts Median PFS for pts with SD was 192 weeks for all pts 67 weeks 95 CI 643–714 weeks PFS after 1 year was 103 with a median overall survival of 181 weeks Treatmentrelated adverse events were generally mild including rash grade 1 in 5 pts After a single dose of 200 mg the t1/2 was calculated to 45 h Conclusion These data confirm that nimotuzumab is safe and very well tolerated To improve efficacy a randomized placebocontrolled trial with Gem has been initiated

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