LIBRETTO-432, a phase III study of adjuvant selpercatinib or placebo in stage IB-IIIA RET fusion-positive non-small-cell lung cancer
Journal
Future oncology (London, England)
Journal Volume
18
Journal Issue
28
Pages
3133
Date Issued
2022-09
Author(s)
Tsuboi, Masahiro
Goldman, Jonathan W
Wu, Yi-Long
Johnson, Melissa L
Paz-Ares, Luis
Besse, Benjamin
Su, Weiji
Chao, Bo H
Drilon, Alexander
Abstract
Selpercatinib, a first-in-class, highly selective and potent central nervous system-active RET kinase inhibitor demonstrated clinically meaningful activity with manageable toxicity in pretreated and treatment-naive advanced/metastatic RET fusion-positive non-small-cell lung cancer (NSCLC). LIBRETTO-432 is a global, randomized, double-blind, phase III trial evaluating selpercatinib versus placebo in stage IB-IIIA, RET fusion-positive NSCLC, previously treated with definitive surgery or radiation; participants must have undergone available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, per investigator's discretion. The primary end point is investigator-assessed event-free survival (EFS) in the primary analysis population (stage II-IIIA RET fusion-positive NSCLC). Key secondary end points include EFS in the overall population, overall survival, and time to distant disease recurrence in the central nervous system.
Subjects
RET fusion-positive; RET kinase inhibitor; RET rearrangement; adjuvant therapy; early stage; non-small-cell lung cancer; phase III trial; selpercatinib; stage IB; stage II; stage IIIA; targeted therapy
SDGs
Publisher
FUTURE MEDICINE LTD
Type
review