dc.contributor.author | Lindén, O | |
dc.contributor.author | Bates, AT | |
dc.contributor.author | Cunningham, D | |
dc.contributor.author | Hindorf, C | |
dc.contributor.author | Larsson, E | |
dc.contributor.author | Cleton, A | |
dc.contributor.author | Pinkert, J | |
dc.contributor.author | Huang, F | |
dc.contributor.author | Bladt, F | |
dc.contributor.author | Hennekes, H | |
dc.contributor.author | Oedegaardstuen, L-I | |
dc.contributor.author | Sturm, I | |
dc.contributor.author | McNamara, C | |
dc.date.accessioned | 2021-07-09T14:24:21Z | |
dc.date.available | 2021-07-09T14:24:21Z | |
dc.date.issued | 2021-04-21 | |
dc.identifier.citation | Cancer biotherapy & radiopharmaceuticals, 2021 | |
dc.identifier.issn | 1084-9785 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4679 | |
dc.identifier.eissn | 1557-8852 | |
dc.identifier.doi | 10.1089/cbr.2020.4653 | |
dc.description.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. | |
dc.format | Print-Electronic | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc/4.0 | |
dc.title | Thorium-227-Labeled Anti-CD22 Antibody (BAY 1862864) in Relapsed/Refractory CD22-Positive Non-Hodgkin Lymphoma: A First-in-Human, Phase I Study. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2021-04-21 | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1089/cbr.2020.4653 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by-nc/4.0 | |
rioxxterms.licenseref.startdate | 2021-04-21 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Cancer biotherapy & radiopharmaceuticals | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham) | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham) | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published | |
pubs.embargo.terms | Not known | |
icr.researchteam | Medicine (RMH Smith Cunningham) | |
icr.researchteam | Medicine (RMH Smith Cunningham) | en_US |
dc.contributor.icrauthor | Cunningham, David | |