Titre
Safety and anti-tumor activity of lisavanbulin administered as 48-hour infusion in patients with ovarian cancer or recurrent glioblastoma: a phase 2a study.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Joerger, M.
Auteure/Auteur
Hundsberger, T.
Auteure/Auteur
Haefliger, S.
Auteure/Auteur
von Moos, R.
Auteure/Auteur
Hottinger, A.F.
Auteure/Auteur
Kaindl, T.
Auteure/Auteur
Engelhardt, M.
Auteure/Auteur
Marszewska, M.
Auteure/Auteur
Lane, H.
Auteure/Auteur
Roth, P.
Auteure/Auteur
Stathis, A.
Auteure/Auteur
Liens vers les personnes
Liens vers les unités
ISSN
1573-0646
Statut éditorial
Publié
Date de publication
2023-04
Volume
41
Numéro
2
Première page
267
Dernière page/numéro d’article
275
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Multicenter Study ; Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Résumé
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.
PID Serval
serval:BIB_8938B103AA5D
PMID
Open Access
Oui
Date de création
2023-03-03T14:04:21.296Z
Date de création dans IRIS
2025-05-20T22:03:07Z
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Nom
10637_2023_Article_1336.pdf
Version du manuscrit
published
Licence
https://creativecommons.org/licenses/by/4.0
Taille
1.06 MB
Format
Adobe PDF
PID Serval
serval:BIB_8938B103AA5D.P001
URN
urn:nbn:ch:serval-BIB_8938B103AA5D7
Somme de contrôle
(MD5):e1660a5f0a1ef98b9c96b0762610621c