LIBRETTO-531: a phase III study of selpercatinib in multikinase inhibitor-naïve RET-mutant medullary thyroid cancer

Other authors

Institut Català de la Salut

[Wirth LJ] Department of Medicine, Massachusetts General Hospital, Boston, MA, USA. [Brose MS] Sidney Kimmel Cancer Center of Jefferson University Health, Philadelphia, PA, USA. [Elisei R] Endocrine Unit, Department of Clinical & Experimental Medicine, University of Pisa, Pisa, Italy. [Capdevila J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. IOB Quirón-Teknon, Barcelona, Spain. [Hoff AO] Department of Endocrinology, Endocrine Oncology Unit, Instituto de Cancer do Estado de Sao Paulo, Sao Paulo, Brazil. [Hu MI] Department of Endocrine Neoplasia & Hormonal Disorders, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Vall d'Hebron Barcelona Hospital Campus

Publication date

2022-10-26T12:31:11Z

2022-10-26T12:31:11Z

2022-09



Abstract

Medullary thyroid cancer; Selpercatinib; Targeted therapy


Cáncer medular de tiroides; Selpercatinib; Terapia dirigida


Càncer medul·lar de tiroide; Selpercatinib; Teràpia dirigida


Selpercatinib is a first-in-class, highly selective and potent, central nervous system-active RET kinase inhibitor. In the phase I/II trial, selpercatinib demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pre-treated and treatment-naive patients with RET-mutant medullary thyroid cancer (MTC). LIBRETTO-531 (NCT04211337) is a multicenter, open-label, randomized, controlled, phase III trial comparing selpercatinib to cabozantinib or vandetanib in patients with advanced/metastatic RET-mutant MTC. The primary objective is to compare progression-free survival (per RECIST 1.1) by blinded independent central review of patients with progressive, advanced, multikinase inhibitor-naive, RET-mutant MTC treated with selpercatinib versus cabozantinib or vandetanib. Key secondary objectives are to compare other efficacy outcomes (per RECIST 1.1) and tolerability of selpercatinib versus cabozantinib or vandetanib.

Document Type

Article


Published version

Language

English

Publisher

Future Medicine

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Attribution-NonCommercial-NoDerivatives 4.0 International

http://creativecommons.org/licenses/by-nc-nd/4.0/

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