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

Joerger, Markus; Hundsberger, Thomas; Haefliger, Simon; von Moos, Roger; Hottinger, Andreas F; Kaindl, Thomas; Engelhardt, Marc; Marszewska, Michalina; Lane, Heidi; Roth, Patrick; Stathis, Anastasios (2023). Safety and anti-tumor activity of lisavanbulin administered as 48-hour infusion in patients with ovarian cancer or recurrent glioblastoma: a phase 2a study. Investigational new drugs, 41(2), pp. 267-275. Springer 10.1007/s10637-023-01336-9

[img]
Preview
Text
s10637-023-01336-9.pdf - Published Version
Available under License Creative Commons: Attribution (CC-BY).

Download (1MB) | Preview

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/m2. 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology

UniBE Contributor:

Häfliger, Simon

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1573-0646

Publisher:

Springer

Language:

English

Submitter:

Pubmed Import

Date Deposited:

16 Feb 2023 09:34

Last Modified:

28 Apr 2023 00:14

Publisher DOI:

10.1007/s10637-023-01336-9

PubMed ID:

36792805

Uncontrolled Keywords:

Avanbulin BAL101553 Glioblastoma Lisavanbulin Microtubule-targeting agent

BORIS DOI:

10.48350/178871

URI:

https://boris.unibe.ch/id/eprint/178871

Actions (login required)

Edit item Edit item
Provide Feedback