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67th Annual Meeting Abstracts
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Trial of Sipuleucel-T in Men with Metastatic, Androgen Independent Prostatic Adenocarcinoma (AIPC)
Paul F Schellhammer1, Neal D Shore2, Guy T Bernstein3, Nancy A Dawson4, Leonard G Gomella5, Raymond S Lance1, David G McLeod6, Myron I Murdock7, *Mark W Frohlich8
1Devine Tidewater Urology, Norfolk, VA;2Grand Strand Urology, Myrtle Beach, SC;3Center for Urologic Care, Bryn Mawr, PA;4Georgetown University Medical Center, Washington, DC;5Jefferson Medical College, Philadelphia, PA;6Walter Reed Army Medical Center, Washington, DC;7Mary Crowley Medical Research Center, Dallas, TX;8Dendreon Corporation, Seattle, WA
Introduction: Sipuleucel-T (APC8015, Provenge®) is an autologous cell product consisting of antigen presenting cells (APCs) loaded with prostate antigen PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP) linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). Previous studies demonstrated that sipuleucel-T could result in specific immune responses, was well tolerated, and demonstrated evidence of clinical benefit. We report final overall survival (OS) data from a Phase 3 trial (IMPACT).
Materials & Methods:
512 patients were randomized (2:1) to receive sipuleucel-T or placebo intravenously every 2 weeks x 3. The primary and secondary endpoints were OS and time to objective disease progression (TTP). The sample size was calculated for 88% power at α = 0.05, assuming a hazard ratio (HR) for death of 0.69 (sipuleucel-T vs placebo). The primary treatment p-value used a stratified Cox regression model adjusted for prostate specific antigen (PSA) and lactate dehydrogenase (LDH). The final analysis was performed after 304 death events were recorded.
Results: Baseline demographics by treatment arm will be described. The OS and TTP treatment effect for sipuleucel-T versus placebo (p-value and hazard ratio) will be provided. A summary of the safety profile will be provided.
Conclusions: An assessment of the risk to benefit ratio of sipuleucel-T in men with advanced AIPC will be provided.
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