FDA Grants Fast Track Designation to Second-Line Eryaspase for Pancreatic Cancer

The FDA's Fast Track designation for second-line eryaspase as treatment of patients with metastatic pancreatic cancer underscores the need for new treatment options in this patient population.

The FDA has granted a Fast Track designation to eryaspase (Graspa) for the treatment of patients with metastatic pancreatic cancer in the second-line setting, underscoring the need for new treatment options for this patient population.1

The study is based on findings from the pivotal phase III TRYbeCA-1 clinical trial, which evaluated the agent in the United States and 11 countries in Europe. Eryaspase has been confirmed safe in patients with advanced metastatic pancreatic cancer, according to an update from Erytech, developer of the drug. No new safety signals were observed in analysis of the first 320 patients enrolled to the study.2

“This is yet another significant milestone and meaningful validation of our technology as we continue our TRYbeCA-1 Phase 3 trial evaluating eryaspase in second-line metastatic pancreatic cancer,” said Gil Beyen, chief executive officer of ERYTECH, in a statement.1 “We believe that the FDA’s Fast Track designation for eryaspase underscores its potential to address this high unmet medical need.”

In a prior phase IIb clinical trial, eryaspase led to significant improvements in both overall survival (OS; HR, 0.60) and progression-free survival (PFS; HR, 0.59).

The trial remains ongoing and has enrolled more than 75% of the planned target enrollment of 500 patients. Interim superiority data are expected to be analyzed around the end of 2020 after two-thirds of the events have occurred. Final analysis data are expected in the second half of 2021.

Patient enrollment will continue but is expected to be lower than planned in the coming months due to the coronavirus disease 2019 (COVID-19) pandemic. A 3- to 4-month delay has been projected for the completion of patient enrollment. Despite the challenges caused by COVID-19, enrollment continued as planned through March 2020.2

Patients are randomized 1:1 to receive either eryaspase in combination with the investigator’s choice of standard chemotherapy or chemotherapy alone. Chemotherapy regimens may include gemcitabine/nab-paclitaxel or an irinotecan. The study drug will be administered until disease progression, unacceptable toxicity, or withdrawal of patient consent.

The primary end point is OS, and secondary end points include PFS, objective response rate, duration of response, disease control rate, incidence of treatment-emergent adverse events, and quality of life.

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 to be included in the study. They must also have radiological evidence of progression following their most recent treatment and measurable lesions per RECIST 1.1 criteria.

Patients are ineligible for the study 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%.

References

  1. ERYTECH Granted US FDA Fast Track Designation for Eryaspase in Second-Line Pancreatic Cancer [news release]. Lyon, France: ERYTECH; April 28, 2020. https://yhoo.it/2WbMxYV. Accessed April 29, 2020.
  2. 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 29, 2020.