ERYTECH Provides Update on the TRYbeCA-1 Phase 3 Clinical Trial of Eryaspase in Second Line Pancreatic Cancer

• More than 75% of the planned ~500 patients enrolled in the trial
• Trial to continue as planned after third safety review by independent data monitoring committee
  
• Interim superiority analysis expected around year-end; final analysis in second half of 2021

LYON, France, April 20, 2020 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing red blood cell-based cancer therapeutics, today provided 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.

“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.