Summary of Phase 3 IMPACT Trial Results Presented at AUA Meeting Webcast Conference Call April 28, Nasdaq: DNDN

Size: px

Start display at page:

Download "Summary of Phase 3 IMPACT Trial Results Presented at AUA Meeting Webcast Conference Call April 28, Nasdaq: DNDN"

Maximillian Cameron
5 years ago
Views:

1 Summary of Phase 3 IMPACT Trial Results Presented at AUA Meeting Webcast Conference Call April 28, 2009 Nasdaq: DNDN

2 PROVENGE sipuleucel-t is an autologous active cellular immunotherapy that activates the immune system against prostate cancer P. 2

3 Randomized Phase 3 IMPACT Trial (IMmunotherapy Prostate AdenoCarcinoma Treatment) Asymptomatic or Minimally Symptomatic Metastatic Androgen Independent Prostate Cancer (N=512) 2:1 Sipuleucel-T Q 2 weeks x 3 Placebo Q 2 weeks x 3 P R O G R E S S I O N Treated at Physician discretion Treated at Physician discretion and/or Salvage Protocol S U R V I V A L Primary endpoint: Secondary endpoint: Overall Survival Time to Objective Disease Progression P. 3

4 IMPACT Phase 3 Study: Statistical Analysis Plan» Stratification Factors» Bisphosphonate use» Primary Gleason score» Number of bone metastases» HR and P-values» Calculated from Cox model Adjusted for PSA and LDH» 2 sided p-values» Log rank as sensitivity analysis» Analyses» Interim: one» Final: p < required for statistical significance P. 4

5 Eligibility Criteria» Metastatic castrate resistant prostate cancer» Life expectancy of at least 6 months» Serum PSA 5.0 ng/ml» Castrate level of testosterone (< 50 ng/dl) achieved via medical or surgical castration» Adequate hematologic, renal, and liver function» Negative serology for HIV 1 & 2, HTLV-1, and Hepatitis B & C P. 5

6 Patient Demographics and Baseline Characteristics Sipuleucel-T (N = 341) Placebo (N = 171) Age, median yrs (range) 72 (49 91) 70 (40 89) Race, white (%) ECOG status, 0 (%) Gleason Score 7 (%) Disease localization Bone only (%) Soft tissue only (%) Bone & soft tissue (%) >10 bone mets (%) Bisphosphonate use Prior docetaxel (%) P. 6

7 Baseline Median Laboratory Values Sipuleucel-T (N = 341) Placebo (N = 171) Serum PSA, ng/ml Serum PAP, U/L Alk. Phosphatase, U/L Hemoglobin, g/dl LDH, U/L WBC, 10 3 /µl P. 7

8 IMPACT Overall Survival: Primary Endpoint Intent-to-Treat Population 100 P = (Cox model) HR = [95% CI: 0.614, 0.979] Percent Survival Placebo (n = 171) Median Survival: 21.7 Mos. Median Survival Benefit = 4.1 Mos. PROVENGE (n = 341) Median Survival: 25.8 Mos Survival (Months) P. 8

9 Overall Survival Summary Survival Percentiles (months) N 75% 50% 25% Sipuleucel-T Placebo % Survival (K-M estimates) 24 Mos. 36 Mos. 48 Mos. Sipuleucel-T Placebo P. 9

10 Survival Consistency Between Population Subsets Bisphosphonate Use: Yes No Primary Gleason Grade: 4 3 No. Bone Metastases: > Disease Localization: Single Bone + Soft Tissue ECOG Performance Status: 1 0 Age: Above Median Below Median PSA: Above Median Below Median LDH: Above Median Below Median Alkaline Phos: Above Median Below Median Hemoglobin: Above Median Below Median Favors sipuleucel-t Hazard Ratio (95% Confidence Interval) P. 10

11 Survival Results Confirmed by Multiple Sensitivity Analyses Favors sipuleucel-t Primary Model (Adj. for PSA, LDH) P = Unadjusted/Log Rank P = Adjusted for Docetaxel Use and Timing P = PCa-Specific Survival P = Hazard Ratio (95% Confidence Interval) P. 11

12 Time to Objective Disease Progression» Secondary endpoint» Result» Independent radiologic review» HR=0.951 (95% CI: 0.77,1.17); P=0.628 (log rank)» Consistent with other trials in advanced prostate cancer» Difficult endpoint to measure reliably and doesn t correlate with overall survival P. 12

13 Most Common Adverse Events ( 5%) Higher Rate in sipuleucel-t (p 0.05) Preferred Term Sipuleucel-T N = 338 % Placebo N = 168 % Chills Pyrexia (fever) Headache Influenza-like illness Hypertension Hyperhydrosis P. 13

14 Serious Adverse Events* Safety Population SAE Preferred Term Sipuleucel-T N=338 % Placebo N=168 % Any SAE Pyrexia Cerebrovascular accident Pulmonary embolism Spinal cord compression Nausea Atrial fibrillation Dehydration Cardiac failure congestive Pneumonia Hematuria Deep vein thrombosis Renal failure acute *Occurring in 4 patients P. 14

15 Consistency Across Phase 3 Studies D9901* D9902A* IMPACT ** Integrated** (N = 127) (N = 98) (N = 512) (N=737) Hazard Ratio p-value p = p = p = p < Median Survival Benefit (months) Month survival (%) sipuleucel-t 34% 32% 32% 33% placebo 11% 21% 23% 20% *Unadjusted Cox model & log rank **Cox model adjusted for PSA and LDH P. 15

16 Conclusions of IMPACT Study» First active immunotherapy to demonstrate improvement in overall survival for advanced prostate cancer» Highly favorable benefit to risk profile» Short duration of therapy» Potential to create new treatment paradigm in oncology» Validates potential to apply platform across different cancers P. 16

17 Dendreon has the potential to fundamentally change the way cancer is treated Nasdaq: DNDN

Updated Results of the IMPACT. Metastatic, Castration-Resistant Prostate Cancer (CRPC)

Updated Results of the IMPACT. Metastatic, Castration-Resistant Prostate Cancer (CRPC) Updated Results of the IMPACT Trial of Sipuleucel-T Tfor Metastatic, Castration-Resistant Prostate Cancer (CRPC) Philip Kantoff, MD Dana-Farber a abe Cancer Institute ue Professor of Medicine Harvard Medical