SEATTLE, WA USA (Press Release) - January 30, 2014 -
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- 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
Dendreon Corporation 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.
"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:
- Antigen 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
- Sipuleucel-T in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients ≥80 Years-Old: 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
- Effect of Prior Abiraterone (ABI) or Enzalutamide (ENZ) on Sipuleucel-T (sip-T) Manufacture 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
- Impact 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
- NeuACT, 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 with PROVENGE.
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. For more information about the Company and its programs, visit www.dendreon.com.
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