Transcript Name of Event Presentation - Prostate Health Education Network

Mark Frohlich, MD, SVP and Chief Medical Officer
September 25, 2008
Washington, DC
4th Annual African American Prostate Cancer Disparity Summit
The Prostate Cancer Epidemic
Treatment Continuum
Chemotherapy
Death
Castration
Tumor
volume
&
activity
Local
Therapy
Symptomatic
Asymptomatic
Non-Metastatic
Androgen Dependent
Metastatic
Androgen Independent
Time
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The Prostate Cancer Epidemic:
Current Standard of Care
Docetaxel
Administration
Q 3 Weeks x 10 via infusion
Efficacy
2.4 Month median survival Advantage
HR= 1.32
P=.009
Safety:
Hair Loss
Fatigue
Nausea/Vomiting
Diarrhea
Neutropenia
Nail Changes
Neuropathy
Stomatitis
Peripheral Edema
Change in Taste
Anorexia
Dyspnea
Grade 3/4
Event Rate
65%
53%
42%
32%
32%
30%
30%
20%
19%
18%
17%
15%
Source: Taxotere label
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The Prostate Cancer Epidemic:
Patient Dissatisfaction
100%
Advanced Prostate Cancer Patients
80%
60%
65%
52%
40%
20%
0%
Would Consider
Chemotherapy
Impact on QOL Outweighs Benefit
“Men with late-stage disease need more options. These men and their families shouldn’t have to
compromise their quality of lives. We need better treatments that fight this disease, address the most
painful symptoms, and lessen the side effects of treatment.”
-Thomas Kirk, president and CEO of Us Too International
Source: USTOO Survey Press Release, September 8, 2005; 2006 Prostate Cancer Symposia Poster #222
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Dendreon
» Product Focus: Oncology
» Lead Product: PROVENGE® (sipuleucel-T)
» Headquarters: Seattle
» Commercial Manufacturing: Morris Plains, NJ
» Founded: 1992
» Employees: ~200
Survival is what
matters
Ray -- Prostate Cancer Survivor and
PROVENGE Study Patient
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What is Provenge?
» Provenge is an investigational Active Cellular Immunotherapy (ACI)
» ACIs are a new class of drug, often referred to as “therapeutic cancer
vaccines”
» ACIs are very different from traditional vaccines
Traditional Vaccines:
Therapeutic Cancer Vaccine/ ACIs:
PREVENT disease by, e.g.,
exposing the immune system
to weakened virus or portion
of a virus
TREAT disease by using the body’s
immune system to fight the cancer
Immunotherapies are designed to be
specific, affecting only cancer cells.
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Targeting Tumor Cells and Mounting
a Strong Anti-Cancer Response
Recombinant Prostatic
Acid Phosphatase
(PAP) antigen combines
with resting antigen
presenting cell (APC)
APC takes up
the antigen
Antigen is
processed and
presented on
surface of the APC
Active
T-cell
T-cells proliferate
and attack
cancer cells
Fully activated, the
APC is now
sipuleucel-T
INFUSE PATIENT
Inactive
T-cell
Sipuleucel-T
activates T-cells
in the body
The precise mechanism of sipuleucel-T in prostate cancer has not been established.
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Active Cellular Immunotherapy:
Production and Delivery
• Convenient for both physician and patient
• Complete course of therapy is one month
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PROVENGE Study D9901: Increased Survival
Phase 3 Study in Androgen-Independent PCa
100
sipuleuc el- T ( n= 82)
Probability of Surviving
plac ebo ( n= 45)
75
p = 0.010 ( log r ank)
HR = 1.71 [95% C I: 1.13, 2.58]
50
Median benefit
4.5 months
25
34%
0
11%
0
6
12
18
24
30
36
Months
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Provenge Safety Profile
» Most frequent events associated with product infusion
» Chills
» Fever
» Adverse drug reactions
» Generally mild to moderate in severity
» Majority resolved within 24 hours
» < 3% of patients unable to receive all 3 infusions due to treatmentrelated adverse events
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Regulatory Timeline
» Dendreon completes license application November 2006
» Positive FDA Advisory Panel Meeting March 2007
» FDA requests additional clinical data May 2007
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IMPACT Phase 3 Study (D9902B)
IMmunotherapy for Prostate AdenoCarcinoma Treatment
Asymptomatic or
minimally
symptomatic
Metastatic Androgen
Independent Prostate
Cancer (n=~500)
Provenge
Q 2 weeks x 3
2:1
Placebo
Q 2 weeks x 3
P
R
O
G
R
E
S
S
I
O
N
Treated at
MD
discretion
Followed for survival
PB01 (Salvage)
Q 2 weeks x 3
Overall Survival
Secondary endpoint: Time to Disease Progression
Primary endpoint:
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Regulatory Timeline
» Dendreon completes license application November 2006
» Positive FDA Advisory Panel Meeting March 2007
» FDA requests additional clinical data May 2007
» Confirmatory IMPACT study fully enrolled November 2007
» FDA agrees that either a positive interim or final analysis for
survival from the IMPACT study would be sufficient to meet
request for additional clinical information to support efficacy
claim
» Interim results from IMPACT study in October 2008; final results
in 2009
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Provenge: Addressing an Unmet Need
Chemotherapy Death
Castration
Provenge
Tumor
volume
&
activity
Local
Therapy
Symptomatic
Asymptomatic
Non-Metastatic
Androgen Dependent
Metastatic
Androgen Independent
Time
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Ongoing PROVENGE Clinical Studies
»
Neoadjuvant Trial (n=40, single site study, open for enrollment)
» Assess safety and immune response of PROVENGE prior to radical prostatectomy
» Immune response to PROVENGE will be assessed in the prostatectomy specimen
and in the peripheral blood
» All patients will be scheduled to receive active treatment
»
PRO-ACT Trial (n=120, multicenter study, open for enrollment)
» P07-2 PRO-ACT (PROstate Active Cellular Therapy) study has essentially the same
enrollment criteria as the IMPACT study
» Patients receive PROVENGE made with differing concentrations of immunizing
antigen
» All patients in the trial will receive active treatment
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Case Study
» 83 years old
» Diagnosis of metastatic HRPC
in 2001
» 5 years from receiving treatment
Eduardo -- Prostate Cancer Survivor
and Sipuleucel-T Study D9901 Patient
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Survival is the ultimate goal in cancer treatment…
Improving survival for people with cancer is
a goal worth fighting for.
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