On December 14, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the completion of enrollment in the TRYbeCA-1 Phase 3 trial in second-line pancreatic cancer (Press release, ERYtech Pharma, DEC 14, 2020, View Source [SID1234572850]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
TRYbeCA-1, the pivotal Phase 3 clinical trial evaluating ERYTECH’s lead product candidate, eryaspase, in second-line metastatic pancreatic cancer, has completed patient enrollment. A total of 510 patients participated in the trial, slightly above the target enrollment of 482 patients.
The trial recently accrued the required number of events for the planned interim superiority analysis, to be performed by an Independent Data Monitoring Committee. The results from the interim superiority analysis are expected to be reported in the first quarter of 2021. Since the interim analysis does not include an evaluation for futility, there will be two possible outcomes: the trial will either: (1) continue toward a final analysis, expected in the fourth quarter of 2021, or (2) be concluded early if compelling improvement in overall survival is demonstrated, in which case the Company expects to file for regulatory approval in the United States and in Europe in the second half of 2021.
Earlier this year, the U.S. Food and Drug Administration granted eryaspase Fast Track Designation as a potential second-line treatment for patients with metastatic pancreatic cancer. Eryaspase also benefits from Orphan Drug status in pancreatic cancer in both the United States and Europe.
"We are extremely pleased that the TRYbeCA-1 trial enrollement has continued to progress on schedule despite the challenges caused by the COVID-19 global pandemic," said Dr. Iman El Hariry, Chief Medical Officer of ERYTECH. "This achievement is only possible because of the hard work of the study investigators, hospital staff at the trial sites, patients and their families. We look forward to the outcome of the planned interim analysis for superiority early next year."
"Patients with advanced pancreatic cancer need new treatment options, particularly in the second line setting after failure of gemcitabine-nab-paclitaxel or FOLFIRINOX combinations," added Dr Jean-Philippe Metges, medical oncologist at the University Hospital in Brest (France) and the national coordinator of the TRYbeCA-1 trial for France. "TRYbeCA-1 is one of the largest clinical trials currently open in second-line metastatic pancreatic cancer. If successful, this will lead to a treatment paradigm shift in this disease."
About TRYbeCA-1
TRYbeCA-1 is a randomized controlled Phase 3 clinical trial evaluating ERYTECH’s lead product candidate, eryaspase, in second-line metastatic pancreatic cancer. Target enrollment was 482 patients. Five-hundred and ten patient were enrolled in the trial in close to 90 clinical sites in the United States and 11 countries in Europe and 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 of TRYbeCA1 is overall survival (OS). The trial was designed to detect an OS hazard ratio (HR) of 0.725 with close to 90% power at a single-sided alpha level of 2.5%. An interim superiority analysis, to be performed by an independent data monitoring committee (IDMC), is foreseen on two-thirds of total OS events. Demonstration of improved OS with a single-sided p-value below 0.006 will be considered compelling evidence of survival benefit at this interim analysis and can form the basis for the IDMC to recommend early conclusion of the trial for superiority.
About Pancreatic Cancer
Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year, there are approximately 185,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate below 10%. It is currently the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2030. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life. Approximately 50% of patients are eligible for second-line treatment.