The first FDA-approved prostate cancer vaccine was Sipuleucel-T. On Day 1, leukopheresis is performed at the apharesis center, Day 2-3 Sipuleucel-T is manufactured by the company, and Day 3-4 the patient is infused in the doctor’s office. Sipuleucel-T received approval based off of results from the IMPACT trial which demonstrated a median survival benefit of 4.1 months and HR for OS of 0.775 (95%CI 0.61-0.98) among men with mCRPC for Sipuleucel-T compared to placebo . Based on the Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of prostate carcinoma in December 2016 , the expert panel recommends using Sipuleucel-T early and in less aggressive disease.
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Dr. Gully concluded his presentation with several take-home message points: (i) T-cell poor tumors may require a ‘spark’ to get the immune system to recognize and seek to destroy the tumor, and one way to do this is with a vaccine, (ii) Sipuleucel-T is approved in the US and unblinded data from the PSA-TRICOM study is anticipated soon, (iii) approaches that both steer the immune system and allow effector cells to get to and remain functional within the tumor microenvironment will be optimal.
Speaker: James Gulley, National Cancer Institute, Bethesda, MD, United States of America
Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre, Twitter: @zklaassen_md at the European Society for Medical Oncology Annual Congress - September 8 - 12, 2017 - Madrid, Spain
1. Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010;363(5):411-422.
2. McNeel DG, Bander NH, Beer TM, et al. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of prostate carcinoma. Journal of ImmunoTherapy of Cancer 2016;4:92.
3. Kantoff PW, Schuetz TJ, Blumenstein BA, et al. Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer. J Clin Oncol 2010;28(7):1099-1105.