OncoGenex Pharmaceuticals, Inc. announced today that the Phase 3 ENSPIRIT trial, evaluating custirsen in the treatment of non-small cell lung cancer (NSCLC), is continuing as planned per the recommendation of the Independent Data Monitoring Committee (IDMC) based upon completion of the first interim futility analysis.
“While the results of the study remain blinded to OncoGenex and Teva, we are very pleased that ENSPIRIT has passed this important early interim futility analysis,” said Scott Cormack, President and CEO of OncoGenex told Daily Published. “We remain strong in our belief that targeting mechanisms of treatment resistance is a critical path forward in the fight against cancer and we continue to actively pursue this approach through the two ongoing Phase 3 trials of custirsen and the seven Phase 2 trials of apatorsen in four tumor types.”
The Phase 3 ENSPIRIT trial is an international, randomized, open-label trial designed to evaluate a survival benefit for custirsen in the treatment of advanced or metastatic non-small cell lung cancer in 1,100 patients who have progressed after initial chemotherapy treatment. Patients are randomized to receive custirsen plus docetaxel or docetaxel alone. Patient enrollment to ENSPIRIT was initiated by Teva in September 2012. Two interim futility analyses are planned for stopping the trial. The first of these two futility analyses has now been completed which allows for acceleration of further enrollment. A second futility analysis will be conducted later in the trial. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the evaluation of custirsen in the ENSPIRIT trial.
Custirsen is also being evaluated in the ongoing Phase 3 AFFINITY trial with second-line chemotherapy in men with metastatic castrate-resistant prostate cancer. The expected timing of AFFINITY results is based on a pre-specified number of death events, however the Company currently expect final results to be announced in late 2015 or early 2016.