Contributions
Type: Oral Presentation
Presentation during EHA20: From 13.06.2015 12:30 to 13.06.2015 12:45
Location: Room C1
Background
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any clinical signs of hypersensitivity (silent inactivation). ERY001 improves pharmacokinetics, tolerability and maintain circulating asparaginase (ASPA) activity due to the protective barrier of the erythrocyte membrane
Aims
The study aimed at evaluating the efficacy and safety of ERYASP
Methods
This open, randomized international Phase 3 study enrolled pts with relapsed ALL. The co-primary endpoints were the duration of ASPA activity > 100IU/L and the incidence of ASPA hypersensitivity during induction. Key secondary endpoints were complete remission (CR), minimal residual disease (MRD), event free survival (EFS) and overall survival (OS).The study was powered to detect 3-fold difference in the incidence of allergic reactions between treatments. Pts (n=80), aged 1-55 years were randomized to ERY001 (150 IU/kg, n=26 or L-ASP (10,000 IU/m², n= 28), or to ERY001-exp (prior allergy, n=26).
Results
In the non-allergic pts, ERY001 significantly reduced the incidence of ASPA hypersensitivity (0% vs 43%; p<0.001). ASPA activity >100 IU/l was 21 ±5 vs 9± 8 days in ERY001 and L-ASP, respectively (p<0.001). The CR rate: ERY001 (65%, 95% CI: [51.6:89.8]) vs L-ASP (39%, 95% CI: [23.3:63.1]; p=0.026). Allograft was successfully performed in 65% of ERY001 vs. 46% of L-ASP. The proportion of patients who achieved MRD<10-3 in F1-F2/VANDA was 35% and 25% in ERY001, and L-ASP arms, respectively. At 12 mo, EFS rate was 65% and 49% in ERY001 and L-ASP arm, respectively. Treatment with ERY001 was well tolerated
Summary
ERY001 provides an alternative option for patients with relapsed ALL, which is well tolerated and efficacious
Keyword(s): Acute lymphoblastic leukemia, Asparaginase, Clinical trial, Relapse
Session topic: Translational studies in ALL
Type: Oral Presentation
Presentation during EHA20: From 13.06.2015 12:30 to 13.06.2015 12:45
Location: Room C1
Background
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any clinical signs of hypersensitivity (silent inactivation). ERY001 improves pharmacokinetics, tolerability and maintain circulating asparaginase (ASPA) activity due to the protective barrier of the erythrocyte membrane
Aims
The study aimed at evaluating the efficacy and safety of ERYASP
Methods
This open, randomized international Phase 3 study enrolled pts with relapsed ALL. The co-primary endpoints were the duration of ASPA activity > 100IU/L and the incidence of ASPA hypersensitivity during induction. Key secondary endpoints were complete remission (CR), minimal residual disease (MRD), event free survival (EFS) and overall survival (OS).The study was powered to detect 3-fold difference in the incidence of allergic reactions between treatments. Pts (n=80), aged 1-55 years were randomized to ERY001 (150 IU/kg, n=26 or L-ASP (10,000 IU/m², n= 28), or to ERY001-exp (prior allergy, n=26).
Results
In the non-allergic pts, ERY001 significantly reduced the incidence of ASPA hypersensitivity (0% vs 43%; p<0.001). ASPA activity >100 IU/l was 21 ±5 vs 9± 8 days in ERY001 and L-ASP, respectively (p<0.001). The CR rate: ERY001 (65%, 95% CI: [51.6:89.8]) vs L-ASP (39%, 95% CI: [23.3:63.1]; p=0.026). Allograft was successfully performed in 65% of ERY001 vs. 46% of L-ASP. The proportion of patients who achieved MRD<10-3 in F1-F2/VANDA was 35% and 25% in ERY001, and L-ASP arms, respectively. At 12 mo, EFS rate was 65% and 49% in ERY001 and L-ASP arm, respectively. Treatment with ERY001 was well tolerated
Summary
ERY001 provides an alternative option for patients with relapsed ALL, which is well tolerated and efficacious
Keyword(s): Acute lymphoblastic leukemia, Asparaginase, Clinical trial, Relapse
Session topic: Translational studies in ALL