Dendreon Announces Presentation of PROVENGE® (sipuleucel-T) Data at the 2014 Genitourinary Cancer Symposium (ASCO GU)
- Data Reaffirm Positive Immune Effects of PROVENGE® (sipuleucel-T) in Treatment of Advanced Prostate Cancer
- Preliminary Phase II Data for DN24-02 Demonstrate Positive Immune Response in HER2+ Urothelial Cancer Patients
SEATTLE--(BUSINESS WIRE)--January 30, 2014 – Dendreon Corporation (NASDAQ:DNDN) today announced the presentation of four PROVENGE® (sipuleucel-T) abstracts and one abstract for DN24-02, an investigational active cellular immunotherapy, from ongoing clinical trials at the 2014 Genitourinary Cancers Symposium (ASCO GU) from January 30-February 1, 2014 in San Francisco, California.
“These results are particularly exciting because they further our understanding of the sipuleucel-T mechanism of action and may enable identification of post-treatment biomarkers of clinical outcome.”
“The PROVENGE and DN24-02 research presented at this year's ASCO GU Symposium demonstrate Dendreon's ongoing commitment to our immuno-oncology franchise and patients in need of new and innovative treatment options for cancer,” said Andrew S. Sandler, M.D., executive vice president and chief medical officer at Dendreon. “These data further elucidate the mechanism underlying the PROVENGE treatment effect and further our understanding of the role of immunotherapy in cancer treatment.”
The data featuring PROVENGE and DN24-02 studies include:
Spread and Survival with Sipuleucel-T in Patients with Advanced
Prostate Cancer (Abstract #88). In the pivotal Phase
III IMPACT study, post-hoc subset data demonstrate PROVENGE treatment
may result in humoral antigen spread, a process by which the immune
response broadens over time to target multiple cancer-related
antigens. Additionally, this effect was found to be associated with
improved overall survival. These results contribute to an
understanding of the mechanism of action for PROVENGE and may enable
identification of post-treatment biomarkers of clinical outcome.
Poster Session A: Prostate Cancer, Thursday, January 30, 11:30 AM – 1:00 PM PST, Golden Gate Hall Lead Author: Charles G. Drake, M.D., Ph.D., Johns Hopkins University School of Medicine, Baltimore, MD
in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients ≥80
Data from PROCEED (Abstract #64). A subgroup analysis
from the Phase IV registry suggests that PROVENGE can induce adequate
immune responses in patients who are 80 years old or older.
Poster Session A: Prostate Cancer, Thursday, January 30, 11:30 AM – 1:00 PM PST, Golden Gate Hall Lead Author: Chadi Nabhan, M.D., FACP, The University of Chicago, Chicago, IL
of Prior Abiraterone (ABI) or Enzalutamide (ENZ) on Sipuleucel-T
in PROCEED Patients (pts) (Abstract #185). A subgroup
analysis from the Phase IV PROCEED registry suggests that prior
treatment with abiraterone acetate or enzalutamide does not negatively
impact PROVENGE manufacturing or product parameters. These results are
consistent with prior analyses demonstrating a positive PROVENGE
treatment immune effect in patients who have received prior therapies.
Poster Session A: Prostate Cancer, Thursday, January 30, 11:30 AM – 1:00 PM PST, Golden Gate Hall Lead Author: Nicholas J. Vogelzang, M.D., Comprehensive Cancer Centers of Nevada, Las Vegas, NV
of Prior Radiation Treatment (tx) on Sipuleucel-T (sip-T) Product
Parameters in PROCEED
Patients (pts) (Abstract #183). In a Phase IV registry
study, data suggest prior palliative radiation to bone metastases does
not preclude successful production of PROVENGE.
Poster Session A: Prostate Cancer, Thursday, January 30, 11:30 AM – 1:00 PM PST, Golden Gate Hall Lead Author: Steven E. Finkelstein, M.D., 21st Century Oncology Translational Research Consortium, Scottsdale, AZ
a Phase II, Randomized, Open-Label Trial of DN24-02: Updated Analysis
of HER2 Expression,
Immune Responses, Product Parameters, and Safety in Patients with
Surgically Resected HER2+ Urothelial Cancer (Abstract #296).
In NeuACT, data on HER2 expression screening of primary tumor and
lymph node samples confirm that HER2 expression is common in
muscle–invasive and node positive urothelial cancer. A preliminary
analyses of the immune response data show treatment with DN24-02
results in an immunologic prime-boost effect similar to that observed
Poster Session B: Prostate, Penile, Urethral, and Testicular Cancers, and Urothelial Carcinoma, Friday, January 31, 12:30 PM – 1:30 PM PST, Golden Gate Hall Lead Author: Dean F. Bajorin, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY
“Data from the Phase III IMPACT study demonstrate that treatment with sipuleucel-T may result in humoral antigen spread, which was found to be associated with improved overall survival,” said Daniel Petrylak, M.D., professor of medicine, director of Genitourinary Oncology, co-director of Signal Transduction Research Program, Yale Cancer Center and Smilow Cancer Hospital at Yale New Haven. “These results are particularly exciting because they further our understanding of the sipuleucel-T mechanism of action and may enable identification of post-treatment biomarkers of clinical outcome.”
PROVENGE Indication and Important Safety Information
PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For more information on PROVENGE, please see the full prescribing information at http://www.provenge.com or call 1-877-336-3736.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucelT), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington, and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements regarding the expected benefits of the recent and prior restructurings, the timing and elements of the restructurings, the timing and form of related charges, the expected annual operating expense reductions, expectations and beliefs regarding Dendreon's financial position, profitability and Dendreon's ability to break even and achieve improved performance as a result of the restructurings, statements regarding sequencing studies, statements regarding studies to advance understanding of immunotherapy and the treatment of advanced prostate cancer, statements regarding biomarkers, expectations about automation or the early detection study, expectations about advancing our pipeline, expectations regarding reductions of cost of goods sold, expectations regarding reimbursement approvals of PROVENGE® in Europe or Dendreon’s ability to launch and commercialize PROVENGE in Europe, expectations regarding the presentation of clinical data, developments affecting Dendreon's U.S. and global business and prospects, beliefs and expectations regarding potential revenue and earnings from product sales, including beliefs regarding Dendreon's ability to grow sales, expectations regarding market size, target market, and market opportunity, beliefs regarding the impact of our direct to consumer advertising, expectations with respect to our sales force execution and effectiveness, progress generally on commercialization efforts for PROVENGE, and expectations about clinical trial enrollments. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Dendreon's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, our inability to achieve and sustain commercial success for PROVENGE; the identification of efficacy, safety or other issues with PROVENGE; a slower than anticipated adoption by treating physicians of PROVENGE for the treatment of patients with advanced prostate cancer for a variety of reasons, including competing therapies, instability in our sales force, the risk that we cannot replace vacant sales positions on a prompt basis, perceived difficulties in the treatment process, delays in obtaining reimbursement or for other reasons; any promotional limitations imposed by the FDA or the EU on our ability to commercialize and market PROVENGE; unexpected difficulties and costs associated with the rapid expansion of our commercial operations to support the commercial launch of PROVENGE; the impact of competing therapies on sales of PROVENGE, the failure to achieve reimbursement approvals in Europe, manufacturing or quality difficulties, disruptions or delays and other factors discussed in the "Risk Factors" section of Dendreon's Annual Report on Form 10-Q for the quarter ended September 30, 2013. All forward-looking statements are qualified in their entirety by this cautionary statement. Dendreon is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.