“The median survival of four years following treatment with PROVENGE is meaningful,” said Celestia S. Higano, M.D., FACP, lead author of the PROCEED analysis, and professor, Division of Medical Oncology, Department of Medicine, University of Washington School of Medicine and Fred Hutchinson Cancer Research Center.
“PROCEED provides a real-world portrait of the expected OS after sipuleucel-T in mCRPC patients in the modern era of five additional life-prolonging agents.”Notably, 44% of patients with a PSA of <5.27 ng/mL did not receive any additional cancer treatments for at least one year. Of those, 95% were treated with PROVENGE as first-line therapy for mCRPC as recommended by the National Comprehensive Cancer Network (NCCN).
“Median baseline PSA levels at mCRPC diagnosis have declined steadily since the approval of PROVENGE in 2010,” said Bruce A. Brown, M.D., chief medical officer at Dendreon. “Of the nearly 2,000 patients enrolled in PROCEED between 2011-2014 a quarter had a PSA of <5.27 ng/mL, and these men lived much longer than those in the higher quartiles. It’s worth noting that the median baseline PSA levels observed in PROCEED are lower than those in the pivotal IMPACT trial and would likely be lower if PROCEED was enrolling today.”
PROCEED Registry – Baseline PSA and Median Survival
- <5.27 ng/mL – 47.7 months
- >5.27 to ≤15.08 ng/mL – 33.2 months
- >15.08 to ≤ 46 ng/mL – 27.2 months
- >46 ng/mL – 18.4 months
1. Higano CS, Armstrong AJ, Sartor AO, et al. Real‐world outcomes of sipuleucel‐T treatment in PROCEED, a prospective registry of men with metastatic castration‐resistant prostate cancer. Cancer 2019
2. Schellhammer PF, Chodak G, Whitmore JB, Sims R, Frohlich MW, Kantoff PW. Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial. Urology. 2013;Jun;81(6):1297-1302.
Source: Dendreon Pharmaceuticals. 2019. "Largest Real-World Study of Immunotherapy Shows Men with Advanced Prostate Cancer with Low PSA had a Median Survival of Nearly Four Years after Treatment with PROVENGE® (sipuleucel-T)". Businesswire.com.