Per a planned interim superiority analysis conducted by an independent data monitoring committee, a trial of Eryaspace will continue without modification with final results anticipated later this year.
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. Participants were randomized 1:1 to receive Eryaspase in combination with standard chemotherapy of either gemcitabine and nab-paclitaxel (Abraxane) or an irinotecan-based regimen or chemotherapy alone.
The trial protocol included 1 interim efficacy analysis, which was to be performed by the IDMC upon the accrual of 261 death events. A final efficacy analysis will also be performed upon reaching a total of 390 events.
The TRYbeCA-1 trial is now fully enrolled and Erytech Pharma anticipates the final analysis will be reported in the fourth quarter of 2021.
“This IDMC review was the first combined efficacy and safety review. We are pleased that no safety issues were raised.” Gil Beyen, chief executive officer of Erytech Pharma, said in a press release. “The trial will now continue to the final efficacy analysis. With 512 patients enrolled, the trial has approximately 90% power to detect the trial’s design hazard ratio of 0.725. Second-line pancreatic cancer is a devastating disease and remains a large unmet medical need. We are hopeful that TRYbeCA-1 can confirm the survival benefit we observed in the Phase 2b clinical trial and eryaspase can be a potential treatment for these patients. We look forward to sharing final results later this year.”
Eryaspase is designed to target the altered asparagine and glutamine metabolism of cancer cells. Its unique mechanism of action encapsulates L-asparaginase inside donor-derived red blood cells. In addition to being studied as a second-line treatment of pancreatic cancer, the agent is currently being evaluated in a phase 2 trial for the treatment of triple-negative breast cancer (NCT03674242). In addition, an investigator-sponsored phase 2 trial (NCT03267030) in acute lymphoblastic leukemia (ALL) recently reported positive results and an investigator-sponsored phase 1 trial (NCT04292743) in first-line pancreatic cancer remains ongoing.
Orphan drug status was previously granted to eryaspace by the FDA and the European Medicines Agency for the treatment of pancreatic cancer and ALL. The agent also received fast track designation from the FDA for the treatment of second-line pancreatic cancer.
ERYTECH Announces TRYbeCA-1 Phase 3 Trial in 2L Pancreatic Cancer to Continue to Final Analysis. News release. ERYTECH Pharma. Published February 8, 2021. Accessed February 9, 2021. http://www.globenewswire.com/news-release/2021/02/08/2171019/0/en/ERYTECH-Announces-TRYbeCA-1-Phase-3-Trial-in-2L-Pancreatic-Cancer-to-Continue-to-Final-Analysis.html#:~:text=The%20TRYbeCA%2D1%20trial%20is,the%20fourth%20quarter%20of%202021.&text=%E2%80%9CThe%20trial%20will%20now%20continue,design%20hazard%20ratio%20of%200.725.