Phase III study of selpercatinib vs chemotherapy plus /- pembrolizumab in untreated RET positive non-small-cell lung cancer

被引:34
作者
Solomon, Benjamin J. [1 ]
Zhou, Cai Cun [2 ]
Drilon, Alexander [3 ]
Park, Keunchil [4 ]
Wolf, Jurgen [5 ]
Elamin, Yasir [6 ]
Davis, Hannah M. [7 ]
Soldatenkova, Victoria [7 ]
Sashegyi, Andreas [7 ]
Lin, Aimee Bence [7 ]
Lin, Boris K. [7 ]
Loong, Herbert H. [8 ]
Novello, Silvia [9 ]
Arriola, Edurne [10 ]
Perol, Maurice [11 ]
Goto, Koichi [12 ]
Santini, Fernando C. [13 ]
机构
[1] Peter MacCallum Canc Ctr, Melbourne, Vic, Australia
[2] Shanghai Pulm Hosp, Shanghai, Peoples R China
[3] Mem Sloan Kettering Canc Ctr, New York, NY 10065 USA
[4] Sungkyunkwan Univ, Samsung Med Ctr, Sch Med, Seoul, South Korea
[5] Univ Hosp Cologne, Ctr Integrated Oncol, Cologne, Germany
[6] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
[7] Eli Lilly & Co, Indianapolis, IN 46225 USA
[8] Chinese Univ Hong Kong, Hong Kong, Peoples R China
[9] Univ Turin, Dept Oncol, AOU San Luigi Orbassano, Turin, Italy
[10] Hosp del Mar, Barcelona, Spain
[11] Leon Berard Canc Ctr Lyon, Lyon, France
[12] Natl Canc Ctr Hosp East, Chiba, Japan
[13] Hosp Sirio Libanes, Ctr Oncol, Sao Paulo, Brazil
关键词
non-small-cell lung cancer; Phase III trial; RET fusion-positive; RET kinase inhibitor; RET rearrangement; selpercatinib; targeted therapy; ALK; REARRANGEMENTS; EFFICACY; FUSIONS; IPILIMUMAB; MUTATIONS; BLOCKADE; NSCLC; EGFR; BRAF;
D O I
10.2217/fon-2020-0935
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Selpercatinib, a novel, highly selective and potent, inhibitor of RET, demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive RET fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial. LIBRETTO-431 (NCT04194944) is a randomized, global, multicenter, open-label, Phase III trial, evaluating selpercatinib versus carboplatin or cisplatin and pemetrexed chemotherapy with or without pembrolizumab in treatment-naive patients with locally advanced/metastatic RET fusion-positive nonsquamous non-small-cell lung cancer. The primary end point is progression-free survival by independent review. Key secondary end points include overall survival, response rate, duration of response and progression-free survival.
引用
收藏
页码:763 / 773
页数:11
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