Safety and anti-tumor activity of lisavanbulin administered as 48-hour infusion in patients with ovarian cancer or recurrent glioblastoma: a phase 2a study.

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Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_8938B103AA5D
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Safety and anti-tumor activity of lisavanbulin administered as 48-hour infusion in patients with ovarian cancer or recurrent glioblastoma: a phase 2a study.
Journal
Investigational new drugs
Author(s)
Joerger M., Hundsberger T., Haefliger S., von Moos R., Hottinger A.F., Kaindl T., Engelhardt M., Marszewska M., Lane H., Roth P., Stathis A.
ISSN
1573-0646 (Electronic)
ISSN-L
0167-6997
Publication state
Published
Issued date
04/2023
Peer-reviewed
Oui
Volume
41
Number
2
Pages
267-275
Language
english
Notes
Publication types: Multicenter Study ; Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862), a microtubule-destabilizing agent. The goal of this study (NCT02895360) was to characterize the safety, tolerability and antitumor activity of lisavanbulin administered as a 48-hour intravenous (IV) infusion at the recommended Phase 2 dose (RP2D) of 70 mg/m <sup>2</sup> . Results from the Phase 1 dose-escalation portion of the study identifying the RP2D have been previously reported. Here, we present the findings from the Phase 2a portion of this study. Methods. This multi-center, open-label study included patients with ovarian, fallopian-tube, or primary peritoneal cancer that was either platinum-resistant or refractory (11 patients), or with first recurrence of glioblastoma (12 patients). Lisavanbulin was administered as a 48-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle. Results. Lisavanbulin was well tolerated in both patient cohorts. Thirteen patients (56.5%) developed 49 adverse events assessed as related to study treatment. The majority were mild or moderate; four were grade 3/4. Sixteen SAEs were reported in nine patients (39.1%), with none considered related to study treatment. No AEs led to permanent treatment discontinuation. Three patients in the ovarian cancer cohort had stable disease with lesion size reductions after two cycles of treatment; in the glioblastoma cohort, one patient showed partial response with a > 90% glioblastoma area reduction as best response, and one patient had stable disease after eight cycles of treatment. Conclusion. This study demonstrated a favorable safety and tolerability profile of 48-hour continuous IV infusion of lisavanbulin in patients with solid extracranial tumors or glioblastoma. Clinicaltrials.gov registration: NCT02895360.
Keywords
Humans, Female, Glioblastoma, Neoplasm Recurrence, Local/drug therapy, Ovarian Neoplasms/drug therapy, Ovarian Neoplasms/pathology, Avanbulin, BAL101553, Lisavanbulin, Microtubule-targeting agent
Pubmed
Web of science
Open Access
Yes
Create date
03/03/2023 16:04
Last modification date
18/11/2023 8:08
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