In reviewing this PR again the questions begs just how good the results can be demonstrated with this new knowledge to design the trails being established.
-- SUNRISE Data Analysis Demonstrates Statistically Significant Overall Survival (OS) Improvement in Patients Receiving Bavituximab plus Docetaxel and Subsequent Immunotherapy Compared to Placebo plus Docetaxel and Subsequent Immunotherapy --
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies, and advancing its proprietary R&D pipeline, today announced the presentation of results of a new analysis of the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Data demonstrated that for patients in the study's bavituximab plus docetaxel treatment arm who received subsequent immunotherapy, the median overall survival (mOS) was not reached, while mOS was 13.0 months for patients in the study's placebo plus docetaxel arm who received subsequent immunotherapy [HR = 0.43; p=0.005]. These are the first clinical results reported supporting the hypothesis that bavituximab may modulate the tumor microenvironment to enhance the anti-tumor activity of immunotherapy agents. Data were presented by Peregrine scientists at the 2017 Annual Meeting of the American Association for Cancer Research (AACR), which is being held April 1-5, 2017 in Washington, D.C.
The presentation highlighted an analysis in which the company evaluated the impact of subsequent immunotherapy treatment, as well as patients' pre-treatment interferon gamma (IFN-γ) levels on overall survival. Overall, low peripheral IFN-γ correlated with more favorable OS in the patients receiving bavituximab + docetaxel and is a biomarker of interest. Data were also analyzed by low versus high IFN-γ levels. For patients with low pre-treatment IFN-γ levels who received subsequent immunotherapy, those in the bavituximab plus docetaxel arm did not reach mOS compared to mOS of 12.1 months for the placebo plus docetaxel arm [HR = 0.24; p < 0.001].
Needs to be repeated.....
Data demonstrated that for patients in the study's bavituximab plus docetaxel treatment arm who received subsequent immunotherapy, the median overall survival (mOS) was not reached
