- A formulation of asparaginase in erythrocytes shows signs of efficacy in advanced pancreatic cancer, with tolerable toxicity.
Why this matters
- Asparaginase is used to treat acute lymphoblastic leukemia, but its use in solid tumors has been limited by toxicity. Encapsulation of the enzyme in erythrocytes could reduce toxicity.
- Phase 2b open-label study in which patients were randomly assigned 2:1 to erythrocyte-encapsulated asparaginase (eryaspase) plus gemcitabine or mFOLFOX6 (oxaliplatin 85 mg/m2 intravenously [IV] on day 1, leucovorin 400 mg/m2, 5-FU 400 mg/m2 by IV bolus, and continuous IV infusion of 5-FU 2400 mg/m2 over the course of 46 hours, every 2 weeks) or gemcitabine or mFOLFOX6 alone (n=141).
- Funding: ERYtech Pharma.
- Among patients with low asparagine synthetase expression, median OS trended toward longer in the eryaspase group (6.2 vs 4.9 months; HR, 0.63; P=.056).
- Overall, the eryaspase group had a higher median OS (6.0 vs 4.4 months; HR, 0.60; P=.008) and PFS (2.0 vs 1.6 months; HR, 0.56; P=.005).
- The most common grade 3/4 adverse events in the eryaspase group were increase in gamma-glutamyltransferase (17.2%), neutropenia (12.9%), and worsening of physical health (12.9%).
- No formal control of multiplicity.