MAAUA 68th Annual Meeting Abstracts
Back to Program
Integrated Safety Results From 4 Randomized, Double-blind, Placebo-controlled Studies Of Sipuleucel-T
Myron I. Murdock1, *Simon J. Hall2, *Paul F. Schellhammer3, *Celestia S. Higano4, *John M. Corman5, *Tomasz M. Beer6, *Eric J. Small7, *Allan J. Pantuck8, *Vahan S. Kassabian9, *Robert B. Sims10
1Urology Associates, PA, Greenbelt, MD;2Mount Sinai School of Medicine,, New York, NY;3Eastern Virginia Medical School, Norfolk, VA;4University of Washington, Seattle, WA;5Virginia Mason Medical Center, Seattle, WA;6Oregon Health and Sciences University, Portland, OR;7University of California San Francisco, San Francisco, CA;8University of California Los Angeles, Los Angeles, CA;9Georgia Urology, Marietta, GA;10Dendreon Corporation, Seattle, WA
Introduction: Sipuleucel-T is an investigational autologous active cellular immunotherapy. Three Phase 3 studies in asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC) demonstrated survival prolongation, and a randomized Phase 3 trial in androgen dependent prostate cancer (ADPC) demonstrated an increase in PSA doubling time.
Materials & Methods: Patients were randomized (2:1, sipuleucel-T:placebo) to receive 3 IV doses in the outpatient setting at approximately 2-week intervals. The safety population included 904 patients who underwent ≥1 leukapheresis (601 sipuleucel-T:303 placebo).
Results: Most patients were Caucasian (90.6%) and had a baseline ECOG performance status of 0 (83.4%); the median age was 70. 93% of patients in the safety population received all 3 infusions. Adverse events (AEs) observed in ≥ 5% of patients randomized to sipuleucel-T and at least twice as frequently in the sipuleucel-T arm were chills, pyrexia, headache, myalgia, influenza-like illness, and hyperhidrosis. Most occurred ≤1 day following infusion, were Grade 1/ 2, and resolved in ≤2 days. Grade 3 acute infusion reactions (AIRs) within 1 day of infusion, including chills, pyrexia, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, myalgia, nausea, and vomiting, occurred in 3.5% of sipuleucel-T and 0% of placebo patients. No Grade 4/5 AIRs were seen. AIRs were treated with acetaminophen, IV H1 and H2 blockers, antiemetics, and IV meperidine.
Conclusions: The majority of common AEs were mild or moderate. AIRs were managed in the outpatient setting.
Back to Program
|
