Provenge Trial Data revised
Thanks Casey, Walldiver, Skcotswonki, Travfourr and FindtheCure.


Patient data:
9901: 127 total
Provenge Group: 82
Placebo group: 45
Placebo crossovers*: 34
Placebo non-crossovers: 11

9902a: 98 total
Provenge Group: 65
Placebo Group: 33
Placebo crossovers: 24 or 25
Placebo non-crossovers: 8 or 9

Pooled 9901 and 9902a: 225 total
Provenge Group: 147
Placebo Group: 78
Placebo Crossovers: 58 or 59
Placebo non-crossovers: 19 or 20

Median Survival in Months:
Provenge Arm 9901: 25.9
Placebo Arm 9901: 21.4
Provenge Arm 9902a: 19.0
Placebo Arm 9902a: 15.7
Provenge Arm Pooled: 23.2
Placebo Arm Pooled: 18.9

Median Survival Benefit in Months:
9901: 4.5 (21%)
9902a: 3.3 (21%)
Pooled: 4.3 (23%)

MS Hazard Ratio/p-value (log rank)
9901: 1.7/p=.01 (41% reduction in risk of death)
9902a: 1.3/p=.33
Pooled: 1.5/p=.011

Hazard Ratio/p-value (Cox Regression)
9901: 2.1/p=.002
9902a: 1.9/p=.023
Pooled: 1.8/p=.0006

36 month survival data:
Provenge Arm 9901: 28/82 = 34.1%
Provenge Arm 9902A: 21/65 = 32.3%
Provenge Arm Pooled: 49/147 = 33.3%

Placebo Arm 9901: 5/45 = 11.1%
Placebo Arm 9902A: 7/33 = 21.2%
Placebo Arm Pooled: 12/78 = 15.4%

Placebo Arm Crossovers 9901: 4/34 = 11.8%
Placebo Arm Crossovers 9902A: 6/24 = 25% or 6/25 = 24%
Placebo Arm Crossovers Pooled: 10/58 = 17.2% or 10/59 = 16.9%

Placebo Arm Non-Crossovers 9901: 1/11 = 9.1%
Placebo Arm Non-Crossovers 9902A: 1/8 = 12.5% or 1/9 = 11.1%
Placebo Arm Non-Crossovers Pooled: 2/19 = 10.5% or 2/20 = 10%

Prostate Specific Survival Numbers: 9901
Provenge Median: 35.2 months
Placebo: 23.5 months
50% reduction in prostate cancer-specific mortality
P-value = 0.002
HR = 2.04

Provenge Plus Taxotere: 9901
Provenge+Taxotere 34.5 months MS
Crossovers* +Taxotere 25.7 months MS
All Placebo +Taxotere 25.4 months MS
Pure Placebo +Taxotere 20.2 months MS

Breakout by Gleason Score: 9901
GS<=6 Provenge arm: 41% or 9/22
GS<=6 placebo arm: 28.6% or 2/7
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GS = 7 Provenge arm: 32.1% or 9/28
GS = 7 placebo arm: 11.1% or 2/18
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GS = 8 Provenge arm: 40% or 4/10
GS = 8 placebo arm: 12.5% or 1/8
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GS>=9 Provenge arm: 27.3% or 6/22
GS>=9 placebo arm: 0% or 0/12

Survival Percentages X 6 month looks:
9901 Actual Survival Rates after X Months in trial
Total 6 12 18 24 30 36
Pro 82 75 63 55 43 36 28
Pla 45 42 30 25 18 11 5

Trial 9902A
Actual Survival Rates after X Months in trial
Total 6 12 18 24 30 36
Pro 65 60 47 34 29 27 21
Pla 33 28 23 15 13 9 7

Combination Trial 9901 + 9902A
Actual Survival Rates after X Months in trial
Total 6 12 18 24 30 36
Pro 147 135 110 89 72 63 49
Pla 78 70 53 40 31 20 12

Trial 9901
% Survival Rates after X Months in trial
6 12 18 24 30 36
Pro 91.5% 76.8% 67.1% 52.4% 43.9% 34.1%
Pla 93.3% 66.7% 55.6% 40.0% 24.4% 11.1%
% increase in survival -2.0% 15.2% 20.7% 31.1% 79.6% 207.3%

Trial 9902A
% Survival Rates after X Months in trial
6 12 18 24 30 36
Pro 92.3% 72.3% 52.3% 44.6% 41.5% 32.3%
Pla 84.8% 69.7% 45.5% 39.4% 27.3% 21.2%
% increase in survival 8.8% 3.7% 15.1% 13.3% 52.3% 52.3%

Combination Trial 9901 + 9902A
% Survival Rates after X Months in trial
6 12 18 24 30 36
Pro 91.8% 74.8% 60.5% 49.0% 42.9% 33.3%
Pla 89.7% 67.9% 51.3% 39.7% 25.6% 15.4%
% increase in survival 2.3% 10.1% 18.1% 23.2% 67.1% 116.7%

*Crossovers got frozen Provenge after first progression and are part of the “placebo” group; many receive chemotherapy upon continued progression