On April 20, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing red blood cell-based cancer therapeutics, reported an update on the pivotal Phase 3 clinical trial for advanced metastatic pancreatic cancer (TRYbeCA-1), which is evaluating the efficacy and safety of ERYTECH’s lead product candidate eryaspase in combination with chemotherapy as second-line therapy (Press release, ERYtech Pharma, APR 20, 2020, View Source [SID1234556450]).
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!
"We are pleased that the TRYbeCA-1 trial has continued to progress well despite the challenges caused by the COVID-19 global pandemic," said Gil Beyen, CEO of ERYTECH. "The third independent safety review has once again confirmed the favorable safety profile of our lead product candidate eryaspase, and the trial has now surpassed 75% of the planned target enrollment. While prioritizing the safety of patients, health care providers and our employees, we have successfully deployed measures to safeguard the integrity of the trial by ensuring patients’ continued access to treatment and appropriate follow-up. The enrollment of new patients is also continuing, but at a slower pace than over the past few weeks. We currently anticipate a limited delay in completing patient enrollment of 3 to 4 months from previous plans. In addition, and unrelated to COVID-19, the average time to events appears longer than originally expected. We now expect the interim superiority analysis around the end of this year and final results in the second half of 2021."
The independent data monitoring committee (IDMC) has reviewed the safety data for the first 320 patients enrolled and treated in the TRYbeCA-1 trial. In line with the two earlier safety reviews, no safety issues were identified and the IDMC recommended to continue the trial as planned.
To date, more than 75% of the approximately 500 patients to be enrolled in the trial have been randomized. Various measures have been put in place to facilitate compliance with the study schedule and to preserve study data integrity.
Through March 2020, new patient enrollment continued as planned notwithstanding the increasing difficulties experienced by the hospitals to organize the proper treatment and follow-up. Over the past two weeks, ERYTECH has observed a reduction in enrollment rate due to the COVID-19 pandemic and now believes new patient enrollment will be below plan in the coming months. The Company currently expects a delay of 3 to 4 months in completion of patient enrollment, bringing the time of complete enrollment to the fourth quarter of this year.
With more than 75% of the patients enrolled in the trial, the Company believes that the planned interim superiority analysis, to be conducted by an IDMC when two-thirds of the total death events have been reached, will not be significantly affected by the expected delay in enrollment. However, based on recent tracking of the total death events in the trial, the average time to event appears longer than originally anticipated. As a result, the Company now expects to report the interim analysis around year-end 2020 and the final analysis in the second half of 2021.
About TRYbeCA-1
TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is designed to enroll approximately 500 patients at approximately 100 clinical sites in Europe and the United States. Eligible patients are 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 TRYbeCA-1 is overall survival. An interim superiority analysis will be conducted when approximately two-thirds of the events have occurred.