FDA Grants Fast Track Designation to Eryaspase in Asparaginase Hypersensitive ALL

The FDA granted fast track designation to eryaspase for the treatment of patients with acute lymphocytic leukemia (ALL) who develop hypersensitivity reactions to Escherichia coli (E. coli)–derived pegylated asparaginase, according to the company responsible for developing the agent, Erytech Pharma.¹

These results follow positive data from the phase 2 NOR-GRASPALL-2016 trial (NCT03267030) that were reported at the 2020 American Society of Hematology Annual Meeting (2020 ASH) that indicated sustained asparaginase enzyme activity 14 days after infusion of eryaspase in most patients with ALL who were also receiving chemotherapy.² 

“This is yet another significant milestone and meaningful inflection point in advancing our lead product candidate eryaspase, further supporting our recently announced intention to submit a [biologics license application] for eryaspase in hypersensitive ALL patients,” Gil Beyen, CEO of Erytech, said in a press release. “We believe that the FDA’s Fast Track designation for eryaspase underscores its potential to address this high unmet medical need.”

NOR-GRASPALL-2016 was a single-arm study examining pharmacokinetic/pharmacodynamic and safety data in patients with Philadelphia chromosome (Ph)–negative ALL who are hypersensitive to pegylated asparaginase. Eryaspase was administered as an intravenous infusion at 150 IU/kg for up to 7 doses, with up to 4 occurring every 2 weeks and up to an additional 3 occurring every 6 weeks.

Patients were eligible for study treatment if they were age 1 to 45 years at the time of ALL diagnosis, have non–high risk ALL, are receiving treatment in the frontline setting, and have documented hypersensitivity to pegylated asparaginase. Patients with Ph-positive ALL, inadequate organ function, or a history of grade 3 or higher transfusion reactions were not eligible for enrollment.

Results from the trial presented at 2020 ASH showed that 54 out of 55 patients with ALL who were treated with eryaspase maintained enzyme activity above 100 U/L at trough levels when therapy was administered every 2 weeks. The therapy was well tolerated, and most patients received the full intended course of treatment with a median of 5 per patients. Two allergic reactions leading to eryaspase withdrawal were noted.

“Maintaining adequate asparaginase treatment following hypersensitivity to [pegylated] asparaginase remains an important goal when treating patients with ALL. A global shortage of supply Erwinia-derived asparaginase, which is the current alternative treatment option to [pegylated] asparaginase, highlights the need for new alternative treatment options,” study investigator Line Stensig Lynggaard, MD, said in a press release. “Our study has demonstrated that eryaspase, given as a convenient schedule every 2 weeks, provides a sustained asparaginase enzyme activity level, few hypersensitivity reactions, and is generally well tolerated in combination with chemotherapy. We conclude that eryaspase is an attractive treatment alternative for ALL patients with hypersensitivity to [pegylated] asparaginase.”

Eryaspase is also being explored as a potential systemic therapy option for the treatment of patients with pancreatic cancer who are receiving treatment in the second-line setting, for which the ongoing phase 3 TRYbeCA-1 trial (NCT03665441) is being carried out. Orphan drug status was previously granted to eryaspase by the FDA and the European Medicines Agency for the treatment of pancreatic cancer and ALL. The agent also received fast track designation from the FDA for the treatment of second-line pancreatic cancer.

References

1. ERYTECH granted U.S. FDA fast track designation for eryaspase in hypersensitive ALL. News release. Erytech Pharma. July 29, 2021. Accessed July 30, 2021. https://bit.ly/3rGLqjk

2. ERYTECH announces positive results from eryaspase phase 2 trial in acute lymphoblastic leukemia presented at the American Society of Hematology Annual Meeting. News release. Erytech Pharma. December 7, 2020. Accessed July 30, 2021. https://bit.ly/3ldSlze