) announced today that four
abstracts featuring PROVENGE^® (sipuleucel-T) data from ongoing Phase II
sequencing studies and the PROCEED registry, and two abstracts highlighting
preliminary Phase II data of DN24-02, an investigational active cellular
immunotherapy in patients with surgically resected HER2+ urothelial cancer,
will be presented at the 49^th Annual Meeting of the American Society of
Clinical Oncology (ASCO) from May 31-June 4, 2013 in Chicago, IL.
Data from an open-label study demonstrate the presence of existing
immunological memory in advanced prostate cancer patients retreated with
PROVENGE several years after initial treatment for androgen dependent prostate
cancer (ADPC) in the Phase III PROTECT study. In addition, the retreatment
appeared to boost product potency compared with prior treatment. Separately,
data from two Phase II studies indicate that PROVENGE can be combined with
androgen deprivation therapy (ADT) or abiraterone acetate plus prednisone.
“These studies help us understand how PROVENGE may be combined or sequenced
with other advanced prostate cancer treatments,” said Mark Frohlich, M.D.,
executive vice president of research and development and chief medical officer
at Dendreon. “We are also pleased with the preliminary data demonstrating that
the antigen-presenting cell activity of DN24-02 for HER2+ urothelial cancer is
similar to that of PROVENGE. The data highlight the promise of our active
cellular immunotherapy platform and furthers Dendreon's position as a leader
in personalized cancer therapies.”
Studies evaluating PROVENGE and DN24-02 data at ASCO include:
PROVENGE:
* A Randomized Phase II Study Evaluating the Optimal Sequencing of
Sipuleucel-T and Androgen Deprivation Therapy (ADT) in
Biochemically-Recurrent Prostate Cancer (BRPC): Immune Results (Abstract
5016). Data suggest that combining ADT with sipuleucel-T may augment
adaptive immunity. PROVENGE is not indicated for the treatment of
biochemically-recurrent prostate cancer.
Poster discussion session: Genitourinary Cancer, Saturday, June 1, 12:00 PM –
1:00 PM CDT., E Arie Crown Theater Lead Author: Emmanuel Stylianos
Antonarakis, M.D., Sidney Kimmel Comprehensive Cancer Center at John Hopkins
University, Baltimore, MD
* A Randomized Phase II Trial of Sipuleucel-T with Concurrent or Sequential
Abiraterone Acetate (AA) Plus Prednisone (P) in Metastatic
Castrate-Resistant Prostate Cancer (mCRPC) (Abstract 5047). In a Phase II
clinical study, the data suggest sipuleucel-T can be successfully
manufactured during concurrent AA plus P with no significant changes in
peripheral immune responses or alterations in adverse event profiles.
General poster session: Genitourinary Cancer, Monday, June 3, 8:00 AM – 11:45
AM CDT., S Hall A2 Lead Author: Eric J. Small, M.D., Department of Medicine,
University of California San Francisco, San Francisco, CA
* Impact of Prior Docetaxel on Sipuleucel-T Product Parameters in PROCEED
Patients (Abstract 5034). In an ongoing, Phase IV registry of patients
administered sipuleucel-T regardless of prior docetaxel use, the data
suggest that antigen presenting cell activation in sipuleucel-T is not
impaired following docetaxel treatment.
General poster session: Genitourinary Cancer, Monday, June 3, 8:00 AM – 11:45
AM CDT., S Hall A2 Lead Author: Celestia S. Higano, M.D., FACP Seattle Cancer
Care Alliance, Seattle, WA
* Open-Label, Multicenter Study of Sipuleucel-T in Men with Metastatic
Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with
Sipuleucel-T: Evaluation of Antigen Presenting Cell (APC) Activation and
ELISPOT Data (Abstract 5053). In a study designed to evaluate the product
potency in the retreatment of patients with sipuleucel-T, the data
indicate the presence of existing immunological memory to sipuleucel-T
years following initial treatment, and retreatment appeared to boost
product potency compared with prior treatment. The patients were initially
treated with sipuleucel-T when they had ADPC, and were retreated after
they developed mCPRC. PROVENGE is not indicated for the treatment of ADPC
and the safety and effectiveness of retreatment have not been established.
General poster session: Genitourinary Cancer, Monday, June 3, 8:00 AM – 11:45
AM CDT., S Hall A2 Lead Author: Tomasz M Beer, M.D., Oregon Health & Science
University Knight Cancer Institute, Portland, OR
DN24-02:
* Preliminary Safety, Product Parameters, and Immune Response Assessments
From A Phase II Randomized, Open-Label Trial of DN24-02, an Autologous
Cellular Immunotherapy (ACI), In Patients with Surgically Resected HER2+
Urothelial Cancer at High Risk for Recurrence (Abstract 4547). In an
ongoing Phase II study, preliminary data on the adverse events and immune
response of DN24-02 indicate that antigen presenting cell activity is
comparable to that of sipuleucel-T and positive immune responses were
observed.
General poster session: Genitourinary (Nonprostate) Cancer, Monday, June 3,
8:00 AM – 11:45 AM CDT., S Hall A2 Lead Author: Dean F. Bajorin, M.D.,
Memorial Sloan-Kettering Cancer Center, New York, NY
* Preliminary HER2 Expression Data from NeuACT, the Phase II Randomized,
Open-Label Trial of DN24-02 in Patients with Surgically Resected HER2+
Urothelial Cancer (UC) at High Risk for Recurrence (Abstract 4527). In an
ongoing Phase II study, preliminary data on HER2 expression in urothelial
cancer suggest a high incidence of HER2 expression (>74%) in urothelial
cancer primary tumor and lymph node specimens from patients, with higher
expression observed in lymph node specimens.
Poster discussion session: Genitourinary (Nonprostate) Cancer, Tuesday, June
4, 11:30 AM – 12:30 PM CDT., E354a Lead Author: Michael Press, M.D.,
University of Southern California Norris Comprehensive Cancer Center, Los
Angeles, CA
