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May 27, 2020 06:00pm
By Lisa Astor
"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."
Eryapase (Graspa) was confirmed safe in patients with advanced metastatic pancreatic cancer after no new safety signal were observed in the first 320 patients enrolled in the pivotal phase III TRYbeCA-1 trial (NCT03665441), according to a press release from Erytech, developer of the drug.
Over 75% of the planned 500 patients have enrolled in the trial. Although investigators expect delays due to the coronavirus disease 2019 (COVID-19) pandemic, enrollment will continue for the TRYbeCA-1 study.
“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, chief executive officer of ERYTECH, in a statement. “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.”
Patient enrollment continued as planned through March 2020 despite the increased challenges of COVID-19. The company observed a reduction in their enrollment rate over the last 2 weeks. New patient enrollment is expected to be lower than planned in the coming months with a projected 3- to 4-month delay for the completion of enrollment.
TRYbeCA-1 is a randomized controlled trial evaluating eryspace in the second-line setting. The trial randomized patients 1:1 to receive either the study drug in combination with standard chemotherapy of the investigator’s choice or chemotherapy alone. Chemotherapy may include either gemcitabine/nab-paclitaxel or an irinotecan-based regimen. Patients will continue treatment until disease progression, unacceptable toxicity, or withdrawal of consent.
The primary end point is overall survival. Secondary end points include progression-free survival, objective response rate, duration of response, disease control rate, the incidence of treatment emergent adverse events, and a quality of life assessment.
To be eligible for enrollment, patients must have either stage III or IV pancreatic adenocarcinoma and have received at least 1 prior line of systemic chemotherapy in the advanced setting. They must also have radiological evidence of progression following their most recent treatment and measurable lesions per RECIST 1.1 criteria. Patients are ineligible to enroll if they have resectable or borderline resectable disease, a histology other than pancreatic adenocarcinoma, at least 1 prior line of therapy in the advanced or metastatic setting, or have experienced a medically significant acute decline in their clinical status, such as a decline in their ECOG performance status or weight loss of ≥10%.
The trial is expected to continue enrollment as planned after a third safety review is conducted by an independent data monitoring committee. The company plans to announce interim superiority data by the end of 2020. The final analysis data are expected in the second half of 2021.
“The enrollment of new patients is also continuing, but at a slower pace than over the past few weeks,” Beyen stated. “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.”
ERYTECH Provides Update on the TRYbeCA-1 Phase 3 Clinical Trial of Eryaspase in Second Line Pancreatic Cancer [news release]. Lyon, France: ERYTECH; April 20, 2020. https://yhoo.it/3eI4iHY. Accessed April 22, 2020.