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At the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, Maese1 presented new data on behalf of the Children’s Oncology Group on the AALL1931 study (NCT04145531), which investigated a recombinant Erwinia chrysanthemi asparaginase, JZP458, in patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL). Similar to other asparaginases used in the treatment of ALL and LBL, JZP458 induces apoptosis in cancer cells.2 A unique benefit of JZP458 is that it can be used in patients who are hypersensitive to E.coli products.1 JZP458 was approved by the FDA in 2021 at a dose of 25 mg/m2 for the treatment of ALL and LBL in patients ≥1 month old.1,3
A total of 167 patients were dosed in part A of this trial; patient characteristics are shown below in Table 1.
Table 1. Patient characteristics*
B-ALL, B-cell acute lymphoblastic leukemia; B-LBL, B-cell lymphoblastic lymphoma; T-ALL, T-cell acute lymphoblastic leukemia; T-LBL, T-cell lymphoblastic lymphoma. |
|||
Characteristics |
Cohort 1a |
Cohort 1b |
Cohort 1c |
---|---|---|---|
Median age, years (range) |
11 |
8 |
12 |
<6, n (%) |
9 (27) |
24 (29) |
11 (22) |
6 to <12, n (%) |
9 (27) |
34 (41) |
14 (27) |
12 to <18, n (%) |
7 (21) |
20 (24) |
18 (35) |
≥18, n (%) |
8 (24) |
5 (6) |
8 (16) |
Male, n (%) |
17 (52) |
55 (66) |
31 (61) |
Primary disease, n (%) |
|
|
|
B-ALL |
27 (82) |
60 (72) |
37 (73) |
T-ALL |
4 (12) |
13 (16) |
9 (18) |
B-LBL |
0 |
0 |
1 (2) |
T-LBL |
2 (6) |
10 (12) |
4 (8) |
Median time (range) since last asparaginase dose received, days |
9 |
10 |
10 |
Eligibility criteria met, n (%) |
|
|
|
Grade ≥3 allergic reaction to an E.coli-derived asparaginase |
27 (82) |
75 (90) |
44 (86) |
Silent inactivation |
3 (9) |
3 (4) |
1 (2) |
Allergic reaction with inactivation |
3 (9) |
5 (6) |
6 (12) |
Figure 1. Patients achieving an NSAA level of ≥0.1 IU/mL in the last 72 hours*
NSAA, nadir serum asparaginase activity.
*Adapted from Maese.1
The findings from part A of the AALL1931 trial demonstrate the efficacy of intramuscular JZP458 at 25/25/50 mg/m2 in patients with ALL or LBL. The safety profile shows the treatment is well tolerated, with a similar safety profile to other asparaginases. Data from part B of this study, expected later this year, will provide more clarification on the potential of using JZP458 intravenously, and the best route of administration of the drug.
References
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