کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2408563 1103180 2007 13 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Lessons from randomized phase III studies with active cancer immunotherapies – Outcomes from the 2006 Meeting of the Cancer Vaccine Consortium (CVC)
کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی ایمونولوژی
پیش نمایش صفحه اول مقاله
Lessons from randomized phase III studies with active cancer immunotherapies – Outcomes from the 2006 Meeting of the Cancer Vaccine Consortium (CVC)
چکیده انگلیسی

After years of effort to develop active cancer immunotherapies, seven candidate products achieved promising results in phase I/II studies that triggered phase III randomized studies. One candidate to date has received an approvable letter from the United States Food and Drug Administration (FDA), defining a clear path to licensure for sipuleucel-T (Provenge®, Dendreon) within the next couple of years. The other phase III studies failed to achieve statistical criteria for some or all of the critical endpoints. Yet, there is widespread recognition that using a patient's own immune system to target and destroy cancer cells may offer an effective biological therapy with less toxicity than presently available anti-cancer therapies, and several candidates are still being evaluated in clinical studies. This review summarizes the lessons learned from these case studies, evaluates scientific, study design, and business factors that can affect study outcomes, identifies common challenges faced by sponsors developing these innovative therapies, and provides considerations for future study designs that may increase the likelihood of success.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 25, Supplement 2, 27 September 2007, Pages B97–B109
نویسندگان
, , , , , ,