On February 8, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that TRYbeCA-1, a Phase 3 clinical trial evaluating eryaspase in second-line pancreatic cancer, will continue without modification following a planned interim superiority analysis conducted by an Independent Data Monitoring Committee (IDMC) (Press release, ERYtech Pharma, FEB 8, 2021, View Source,the%20fourth%20quarter%20of%202021.&text=%E2%80%9CThe%20trial%20will%20now%20continue,design%20hazard%20ratio%20of%200.725. [SID1234574713]).
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The interim analysis was triggered when two-thirds of the total number of events had occurred and allowed the potential for stopping the trial early if the primary endpoint reached statistical significance, adjusting the statistical threshold for the interim review. As with the three previous IDMC reviews, no safety issues have been identified and the Company remains blinded to the primary and secondary endpoint efficacy data. The TRYbeCA-1 trial is fully enrolled and the Company continues to expect the final analysis 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." said Gil Beyen, Chief Executive Officer of ERYTECH Pharma. "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."
About TRYbeCA-1
TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial has enrolled 512 patients, slightly above the target enrollment of 482 patients, at approximately 90 clinical sites in Europe and the United States. Eligible patients were randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone.
The primary endpoint is overall survival (OS). At the target enrollment of 482 patients, the trial is powered to detect an OS benefit, measured as a hazard ratio (HR), of 0.725 (i.e. a reduction in risk of death rate by 27.5%) with 88% probability. The trial protocol includes one interim efficacy analysis, to be performed by the IDMC upon the accrual of 261 death events, and a final efficacy analysis upon reaching a total of 390 events.
About Pancreatic Cancer
Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. It is a particularly aggressive cancer, with a five-year survival rate below 10%. Pancreatic cancer currently the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2030.
Every year, approximately 200,000 new cases of pancreatic cancer are diagnosed in the United States and Europe. Approximately half of these patients are diagnosed with metastatic disease for which limited therapeutic options are currently available. Notwithstanding significant efforts, very little innovation has occurred in advanced pancreatic cancer. Chemotherapy remains the main treatment modality. Approximately 40-50% of the patients treated with chemotherapy are eligible for second-line treatment.