作者
HHF Loong, K Goto, BJ Solomon, K Park, M Pérol, E Arriola, S Novello, Y Cheng, A Ardizzoni, M Mak, FC Santini, YY Elamin, A Drilon, J Wolf, B Han, H Han, M Uh, T Puri, V Ilaria, C Zhou
发表日期
2023/10/1
期刊
Annals of Oncology
卷号
34
页码范围
S1303
出版商
Elsevier
简介
Background
Selpercatinib is a highly selective and potent, brain penetrant RET inhibitor, approved for treatment of advanced RET fusion-positive (RET+) NSCLC. Selpercatinib had not previously been evaluated in a randomized trial.
Methods
LIBRETTO-431 (NCT04194944) is a randomized, open-label, phase 3 trial comparing first-line selpercatinib vs chemotherapy (cisplatin/carboplatin+ pemetrexed)+/-pembrolizumab. The primary endpoint of blinded independent central review (BICR)-assessed PFS was tested first in patients stratified by investigator’s intent to treat with pembrolizumab, if assigned to the control arm,(ITT-pembro) and then in the ITT population. The pre-planned interim efficacy analysis by BICR occurred after 98 PFS events in the ITT-pembro population. Crossover to selpercatinib was allowed following BICR progression on the control arm.
Results
A total of 261 patients were enrolled from 23 …
学术搜索中的文章
HHF Loong, K Goto, BJ Solomon, K Park, M Pérol… - Annals of Oncology, 2023