Immunotherapy works, and has been proven by DNDN. I think we are in a great position as a 2nd generation product that had the ability to learn from the DNDN mistakes and build a better treatment while addressing manufacturing and cost problems. The next 2 years will be life changing, mark my words!
8:04 am Dendreon announces presentation of PROVENGE (sipuleucel-T) data at the 2014 Genitourinary Cancer Symposium; data reaffirm positive immune effects of PROVENGE in treatment of advanced prostate cancer; prelim Phase II Data for DN24-02 demonstrate positive immune response in HER2+ urothelial cancer patients (DNDN) : Co 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 data featuring PROVENGE and DN24-02 studies include:
Antigen Spread and Survival with Sipuleucel-T in Patients with Advanced Prostate Cancer: 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.
Sipuleucel-T in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients =80 Years-Old: Data from PROCEED: 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.
Effect of Prior Abiraterone (ABI) or Enzalutamide (ENZ) on Sipuleucel-T (sip-T) Manufacture in PROCEED Patients (pts): 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.
Impact of Prior Radiation Treatment (tx) on Sipuleucel-T (sip-T) Product Parameters in PROCEED Patients (pts): In a Phase IV registry study, data suggest prior palliative radiation to bone metastases does not preclude successful production of PROVENGE.
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: 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.
