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CD123 is commonly overexpressed in patients with acute myeloid leukemia (AML).1 Pivekimab sunirine is a novel antibody-drug conjugate comprising a high affinity CD123 antibody.1
Here, we summarize the results from a phase I/II dose escalation and dose expansion trial (NCT03386513) investigating the safety and antileukemic activity of pivekimab sunirine in relapsed/refractory AML published by Daver et al.1 in The Lancet Oncology.
Figure 1. A TEAEs Grade ≥3 and B serious TEAEs occurring in ≥5% of patients treated with the RP2D of pivekimab sunirine *
RP2D, recommended phase II dose; TEAE, treatment-emergent adverse event.
*Adapted from Daver, et al.1
Table 1. Efficacy endpoints of patients enrolled in dosing Schedule A and those treated with the RP2D of pivekimab sunirine *
Efficacy endpoint, % (unless otherwise stated) |
Schedule A |
RP2D |
---|---|---|
ORR |
16 |
21 |
Complete remission |
3 |
3 |
Composite complete remission rate |
12 |
17 |
Median duration of ORR, months |
2.0 |
2.6 |
Median duration of composite complete remission, months |
2.2 |
2.3 |
Estimated median OS, months |
2.99 |
5.85 |
ORR, overall response rate; OS, overall survival; RP2D, recommended phase II dose. |
Key learnings |
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