Dendreon Announces Presentation of PROVENGE®(sipuleucel-T) Data at the 2013 ASCO Annual Meeting
Data Evaluate Sequencing of PROVENGE®(sipuleucel-T) in Treatment of Advanced Prostate Cancer and Demonstrate Immune Responses in Patients Retreated With PROVENGE®
Preliminary Phase II Data for DN24-02 for High-Risk Urothelial Carcinoma Demonstrate Positive Immune Response
SEATTLE--(BUSINESS WIRE)-- May 31, 2013- Dendreon Corporation (NASDAQ: DNDN) 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 49th 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:
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 TheaterLead 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 A2Lead 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 A2Lead 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 A2Lead Author: Tomasz M Beer, M.D., Oregon Health & Science University Knight Cancer Institute, Portland, OR
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 A2Lead 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., E354aLead Author: Michael Press, M.D., University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA
"Data from the PROTECT study suggest the presence of existing immunological memory to PROVENGE years following initial treatment and after patients progressed to mCRPC, and retreatment produced a boost in product potency compared with prior treatment," said Tomasz M. Beer, M.D., Grover C. Bagby Endowed Chair for Prostate Cancer Research, professor of medicine, hematology & medical oncology and Director of the Prostate Cancer Research Program, Oregon Health & Science University. "These data suggest that the immune response from PROVENGE continues well beyond the date of infusion and supports our understanding of how PROVENGE works over time."
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 the FDA approved full prescribing information, please visit http://www.provenge.com.
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® (sipuleucel-T), 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 Company's expectations concerning the settlement of the pending securities litigation against the Company and three of its current or former officers, the expected benefits of the restructuring, the timing and elements of the restructuring, the timing and form of related charges, the expected annual operating expense reduction, 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 restructuring, expectations regarding reductions of cost of goods sold, expectations regarding regulatory approval of PROVENGE® in Europe, expectations regarding the presentation of clinical data, developments affecting Dendreon's U.S. and global business and prospects and potential revenue and earnings from product sales, expectations regarding market size and market opportunity, beliefs regarding the impact of our direct to consumer advertising, expectations with respect to our sales force execution, and progress generally on commercialization efforts for PROVENGE. 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 ability to complete documentation of the settlement among the parties to the litigation and with Dendreon's insurers and to obtain court approval of the settlement, neither of which can be assured; 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 due to competing therapies, instability in our sales force, including 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 on our ability to commercialize and market PROVENGE; unexpected difficulties and costs associated with the rapid expansion of our operations to support the commercial launch of PROVENGE; the impact of competing therapies on sales of PROVENGE, and other factors discussed in the "Risk Factors" section of Dendreon's Annual Report on Form 10-K for the year ended December 31, 2012. 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.
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