San Francisco, CA ( — Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, announced the publication of results from its PROCEED registry, which evaluated real-world use of PROVENGE®(sipuleucel-T) in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC). The findings, published in Cancer1 showed that men with mCRPC who were treated with PROVENGE when their PSA was <5.27 ng/mL had a median survival of nearly four years.

“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

Findings from the PROCEED registry are consistent with a previous post-hoc analysis of the pivotal Phase 3 IMPACT trial of sipuleucel-T published in Urology in 2013. In that analysis, a lower baseline PSA level was associated with improved overall survival (OS). Among patients with a baseline PSA ≤22.1 ng/mL, the median OS was 41.3 months (3.4 years) for those treated with sipuleucel-T vs. 28.3 months for those in the control arm – an improvement of 13 months.2References:
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)”.