May 14, 2014 – Dendreon Corporation (NASDAQ:DNDN) announced today the presentation of two PROVENGE® (sipuleucel-T) abstracts from the Phase II STAND study and the PROCEED registry, and one abstract highlighting data from the ongoing Phase II study of DN24-02, an investigational active cellular immunotherapy for patients with surgically resected HER2+ urothelial cancer. These data will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) from May 30-June 3, 2014 in Chicago, Illinois.
Additionally, preliminary data from the Phase II STRIDE study evaluating concurrent or sequential treatment of PROVENGE with enzalutamide are available online at abstracts.asco.org.
“These data continue to help reinforce how PROVENGE may be combined or sequenced with other advanced prostate cancer treatments,” said Andrew S. Sandler, M.D., executive vice president and chief medical officer at Dendreon. “We remain committed to our active cellular immunotherapy platform and expanding the medical community’s understanding of how immuno-oncology treatments can be used to benefit patients.”
Dendreon will present the following studies evaluating PROVENGE and DN24-02 data at ASCO:
- A Randomized Phase II Study Evaluating the Optimal Sequencing of
Sipuleucel-T and Androgen Deprivation Therapy (ADT) in
Biochemically-Recurrent Prostate Cancer (BRPC): Preliminary Clinical
Data. Data from the Phase II STAND study suggest cytokine
responses may be superior when PROVENGE is given after the start of
treatment with ADT (rather than before) to patients with
biochemically-recurrent prostate cancer.
General Poster Session: Monday, June 2, 1:15 PM – 5:00 PM CT, S Hall A2, Poster Board #170
- Time to Chemotherapy Following Treatment with Sipuleucel-T: Data
from PROCEED. An analysis of data from the PROCEED registry
suggests that younger age, lower hemoglobin or higher PSA at baseline
prior to PROVENGE therapy is associated with shorter time to
chemotherapy after PROVENGE.
General Poster Session: Monday, June 2, 1:15 PM – 5:00 PM CT, S Hall A2, Poster Board #169
- Preliminary Product Parameter and Safety Results from NeuACT, a
Phase II Randomized, Open-Label Trial of DN24-02 in Patients with
Surgically Resected HER2+ Urothelial Cancer at High Risk for Recurrence.
A preliminary analysis of data from the randomized Phase II NeuACT
study suggests DN24-02, targeted towards the HER2 antigen, has a
similar immune effect as PROVENGE in the activation of antigen
presenting cells and heightened T-cell cytokines consistent with
immunological prime-boost response.
General Poster Session: Monday, June 2, 1:15 PM – 5:00 PM CT, S Hall A2, Poster Board #109
“These data support the current clinician perception that the future of cancer treatments should be a personalized approach, including immunotherapies,” 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. “We continue to see powerful evidence of meaningful immunological responses to immunotherapies such as sipuleucel-T and investigational compound DN24-02.”
Important Safety Information for PROVENGE
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 1,500 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® (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 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, the dilution or other effects resulting from capital raising or debt restructuring transactions, disruptions or delays and other factors discussed in the "Risk Factors" section of Dendreon's Annual Report on Form 10-K for the year ended December 31, 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.
Lindsay Rocco, 862-596-1304