Thorium-227-Labeled Anti-CD22 Antibody (BAY 1862864) in Relapsed/Refractory CD22-Positive Non-Hodgkin Lymphoma: A First-in-Human, Phase I Study.
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ICR Authors
Authors
Lindén, O
Bates, AT
Cunningham, D
Hindorf, C
Larsson, E
Cleton, A
Pinkert, J
Huang, F
Bladt, F
Hennekes, H
Oedegaardstuen, L-I
Sturm, I
McNamara, C
Bates, AT
Cunningham, D
Hindorf, C
Larsson, E
Cleton, A
Pinkert, J
Huang, F
Bladt, F
Hennekes, H
Oedegaardstuen, L-I
Sturm, I
McNamara, C
Document Type
Journal Article
Date
2021-04-21
Date Accepted
2021-04-21
Date Available
2021-07-09T14:24:21Z
Abstract
Background: BAY 1862864 is an α-particle emitting thorium-227-labeled CD22-targeting antibody. This first-in-human dose-escalation phase I study evaluated BAY 1862864 in patients with CD22-positive relapsed/refractory B cell non-Hodgkin lymphoma (R/R-NHL). Materials and Methods: BAY 1862864 intravenous injections were administered at the starting thorium-227 radioactivity dose of 1.5 MBq (2 or 10 mg antibody), and the radioactivity dose escalated in ∼1.5 MBq increments (10 mg antibody) until the maximum tolerated dose (MTD) was reported. The primary objective was to determine the safety, tolerability, and MTD. Results: Twenty-one patients received BAY 1862864. Two dose-limiting toxicities (grade 3 febrile neutropenia and grade 4 thrombocytopenia) were reported in one patient in the 4.6 MBq (10 mg antibody) cohort. The MTD was not reached. Ten (48%) patients reported grade ≥3 treatment-emergent adverse events, with the most common being neutropenia, thrombocytopenia, and leukopenia, each occurring in 3 (14%) patients. Pharmacokinetics demonstrated the dose proportionality and stability of BAY 1862864 in the blood. The objective response rate (ORR) was 25% (5/21 patients) according to the LUGANO 2014 criteria, including 1 complete and 4 partial responses. The ORR was 11% (1/9) and 30% (3/10) in patients with relapsed high- and low-grade lymphomas, respectively. Conclusions: BAY 1862864 was safe and tolerated in patients with R/R-NHL. The Clinical Trial Registration numbers: NCT02581878 and EudraCT 2014-004140-36.
Citation
Cancer biotherapy & radiopharmaceuticals, 2021
Source Title
Publisher
ISSN
1084-9785
eISSN
1557-8852
Collections
Research Team
Medicine (RMH Smith Cunningham)
Medicine (RMH Smith Cunningham)
Medicine (RMH Smith Cunningham)