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Affinitak fails in Isis trial, now awaits Lilly study

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The future of Isis/Lilly's antisense agent Affinitak rests on outcome of ongoing Lilly Phase III non-small cell lung cancer trial, following failure of Isis' pivotal study. Affinitak, in combo with carboplatin and paclitaxel, did not significantly extend survival versus chemotherapy alone in the 616-patient trial: median survival was 10 months with Affinitak and 9.7 months without. A post-hoc analysis of the 256 patients who completed a full course of Affinitak approached statistical significance, with median survival of 17.4 months vs. 14.3 months for patients on chemo alone (p=.054). Lilly plans to "complete our analysis of this trial and evaluate the performance of Affinitak in our Gemzar/cisplatin combination trial. We will then make a decision about the further development of this drug," Lilly VP-Oncology Paolo Paoletti, MD, said during a March 17 conference cal
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