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Survival In Sipuleucel-T (APC8015) Clinical Trials
Leonard Gomella1, Mark Frohlich*2
1Jefferson Medical College, Philadelphia, PA;2Dendreon Corporation, Seattle, WA
SURVIVAL IN SIPULEUCEL-T (APC8015) CLINICAL TRIALS
Leonard Gomella , Mark Frohlich and the Investigators from D9901 and D9902A
Introduction and Objectives: Sipuleucel-T is an investigational, autologous, active cellular immunotherapy and is designed to elicit a specific T cell immune response against prostatic acid phosphatase in men with advanced prostate cancer.
Methods: As part of a large multi-center clinical trial, subjects were randomized (2:1) to sipuleucel-T or placebo. Eligible subjects had tumor progression following hormonal therapy and no visceral metastases.
Results: Survival results are presented in Table 1. Sipuleucel-T was generally well tolerated with a consistent pattern of Grade 1 and 2 treatment-related adverse events lasting 1 to 2 days.
Conclusions: Sipuleucel-T appears to provide a substantial survival advantage and a strong safety profile.
Table 1. Survival Results from Two Randomized Phase 3 Trials | D9901 (n=127) | D9902A (n=98) | Pooled (n=225) | Median survival:
Sipuleucel-T
Placebo | 25.9 m
21.4 m | 19.0 m
15.7 m | 23.2 m
18.9 m | | Median Survival | 21% (4.5 m) | 21% (3.3 m) | 23% (4.3 m) | | HR; log rank p-value | 1.7; P=0.010 | 1.3; P=0.331 | 1.5; P=0.011 | | HR; Cox p-value | 2.1; P=0.002 | 1.9; P=0.023 | 1.8; P=0.0006 | 36-month Survival:
Sipuleucel-T
Placebo | 34% (28 pts)
11% (5 pts) | 32% (21 pts)
21% (7 pts) | 33% (49 pts)
15% (12 pts) |
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