The phase 3 TRYbeCA-1 trial (NCT03665441) evaluating Eryaspase for the second-line treatment of pancreatic cancer will continue without modification following a planned interim superiority analysis conducted by an independent data monitoring committee (IDMC), according to the therapy’s developer, Erytech Pharma.
The interim analysis was triggered when two-thirds of the total number of events had occurred and permitted the potential for halting the trial early if the primary end point of overall survival (OS) superiority reached statistical significance, adjusting the statistical threshold for the interim review. Importantly, no safety issues have been identified thus far and the company remains blinded to the primary and secondary end point data.
The randomized, controlled trial has enrolled a total of 512 patients at approximately 90 clinical sites in Europe and the United States….
