Sipuleucel-T: Prototype for Development of Anti-tumor Vaccines

Author:

Carballido Estrella,Fishman Mayer

Publisher

Springer Science and Business Media LLC

Subject

Oncology

Reference36 articles.

1. •• O'Day S, Hodi FS, McDermott DF, et al. A phase III, randomized, double-blind, multicenter study comparing monotherapy with ipilimumab or gp100 peptide vaccine and the combination in patients with previously treated, unresectable stage III or IV melanoma. J Clin Oncol 2010, 28:18s: abstract# 4. This positive phase 3 trial showed that ipilimumab alone or combined with immunotherapy resulted in a significant improvement in OS. Ipilimumab trial is open for prostate cancer patients.

2. National clinical trial website. Available at www.clinicaltrials.gov . NCT 01057810–Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer.

3. •• Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer. NEJM 2010, 5:411–22. This is the pivotal trial that showed a difference in the median survival as well as immunologic effects in the treated population, including antibody and T cell–specific activity to P2024 and PAP. This has the most definitive dataset.

4. Small EJ, Schellhammer PF, Higano CS et al. Placebo-Controlled Phase III Trial of Immunologic Therapy with Sipuleucel-T (APC8015) in Patients with Metastatic, Asymptomatic Hormone Refractory Prostate Cancer. J Clin Oncol 2006, 24:3089–94.

5. • Higano CS, Schellhammer PF, Small EJ, Integrated Data From 2 Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trials of Active Cellular Immunotherapy With Sipuleucel-T in Advanced Prostate Cancer. Cancer 2009,115(16):3670–79. This paper aggregates the data from two phase 3 trials with sipuleucel-T.

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