OncoGenex's custirsen Phase 3 ENSPIRIT trial for treatment of NSCLC patients continues as planned

Jul 13 2015

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that its Phase 3 ENSPIRIT trial evaluating custirsen in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) is continuing as planned per the recommendation of an Independent Data Monitoring Committee (IDMC). This decision was based upon completion of the second and final planned interim futility analysis.

"Passing this important milestone strengthens our belief in custirsen and its potential to provide clinical benefit in this patient population with advanced disease and limited treatment options," said Scott Cormack, President and CEO of OncoGenex. "While the ENSPIRIT results remain blinded, this news is particularly exciting following the protocol amendment, which set a high bar for continuing the trial."

Two interim analyses were originally planned to evaluate whether to stop the trial for futility. OncoGenex filed an amendment with the U.S. Food and Drug Administration amending the statistical design and analysis plan that included a more rigorous and expedient evaluation of the potential survival benefit associated with custirsen in NSCLC. Based on current enrollment, initial ENSPIRIT results could be available in the second half of 2016.

"While advancements have been made for NSCLC patients with specific mutations and biomarkers, treatment resistance continues to be a challenge and combination chemotherapy remains the therapeutic backbone for the majority of patients with lung cancer," said Cindy Jacobs, PhD, MD, Chief Medical Officer and Executive Vice President of OncoGenex. "As we continue to gain a better understanding of the patients most likely to benefit from custirsen, we look forward to the results of our two Phase 3 trials in the lung and prostate cancer settings."

Recent findings from a retrospective analysis of data from the Phase 3 SYNERGY trial showed a benefit with custirsen therapy when added to first-line docetaxel chemotherapy in men with metastatic castrate-resistant prostate cancer (CRPC) who had a poor prognosis. The analysis showed that over 40 percent of men in the trial had at least 2 of the 5 common risk factors for poor prognosis. In these men, the analysis found a 27 percent lower risk of death when custirsen was used in combination with first-line docetaxel compared to docetaxel alone. Subject to finalizing the pending protocol amendment, timing for the final analysis of the poor prognosis subpopulation in the Phase 3 AFFINITY trial is projected to occur by the end of 2015, while the final analysis for the intent-to-treat population is projected to occur in the second half of 2016.

SOURCE OncoGenex Pharmaceuticals, Inc.