PROSTVAC™ data presented at the ASCO Meeting demonstrates the potential for significant increases in life expectancy in late-stage prostate cancer
Today, detailed data from a randomized Phase 2 study with PROSTVAC™ were presented at the ASCO Annual Meeting in Orlando. The presentation was made by Philip Kantoff MD, Professor of Medicine, Harvard Medical School, and the Dana-Farber Cancer Institute who is also the principal investigator of the study.
The more detailed analysis supports the headline data that were reported in October 2008. In the Phase 2 prospective randomized placebo-controlled study of 125 patients with advanced prostate cancer, patients in the PROSTVAC™ group had a significantly longer median overall survival by 8.5 months compared to the control group. The hazard ratio estimate for overall survival from the study is 0.56 (95% CI 0.37-0.85).
The statistical significance in the final data set is (p=0.006).
There were no major clinically meaningful imbalances in baseline characteristics in the PROSTVAC™ and control vector treated arms.
PROSTVAC™ immunotherapy was well tolerated, with some patients having injection site reactions (40-60%), and systemic symptoms of fatigue, fevers, and chills (10-30%) reported.
PROSTVAC™ is an 'off-the-shelf' viral vector-based immunotherapy, utilizing pox virus vectors that express PSA and three T cell costimulatory molecules are administered subcutaneously.
An abstract from Professor Kantoff's presentation is now available on ASCO's website: http://www.abstract.asco.org/AbstView_65_33254.html
Slides from the presentation will be available within one week at: http://www.asco.org/ASCOv2/MultiMedia/Virtual+Meeting
Philip Kantoff MD, Professor of Medicine, Harvard Medical School, the principal investigator of the study, said: "There are few available treatments for advanced prostate cancer. To see this extent of improvement in overall survival is very encouraging. These phase II data with PROSTVAC™ warrant confirmation with a phase III study and when confirmed this product has the potential to fulfil an unmet medical need for these patients."
Anders Hedegaard, President & CEO of Bavarian Nordic said: "We are delighted that the data presented at the ASCO Annual Meeting confirms the excellent headline data with our prostate cancer vaccine candidate, PROSTVAC™, ready to start Phase 3 in 2010."