Document Type
Article
Publication Date
9-1-2022
Abstract
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.
Recommended Citation
Wirth, Lori J; Brose, Marcia S; Elisei, Rossella; Capdevila, Jaume; Hoff, Ana O; Hu, Mimi I; Tahara, Makoto; Robinson, Bruce; Gao, Ming; Xia, Meng; Maeda, Patricia; and Sherman, Eric, "LIBRETTO-531: A Phase III Study of Selpercatinib in Multikinase Inhibitor-Naïve" (2022). Department of Medicine Faculty Papers. Paper 388.
https://jdc.jefferson.edu/medfp/388
Creative Commons License
This work is licensed under a Creative Commons Attribution-No Derivative Works 4.0 License.
PubMed ID
35969032
Language
English
Comments
This article is the author’s final published version in Future oncology (London, England), Volume 18, Issue 28, September 2022, Pages 3143 - 3150.
The published version is available at https://doi.org/10.2217/fon-2022-0657. Copyright © Wirth et al.