학술논문
Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial
Document Type
Original Paper
Author
Jiang, Zefei; Ouyang, Quchang; Sun, Tao; Zhang, Qingyuan; Teng, Yuee; Cui, Jiuwei; Wang, Haibo; Yin, Yongmei; Wang, Xiaojia; Zhou, Xin; Wang, Yongsheng; Sun, Gang; Wang, Jingfen; Zhang, Lili; Yang, Jin; Qian, Jun; Yan, Min; Liu, Xinlan; Yi, Tienan; Cheng, Ying; Li, Man; Zang, Aimin; Wang, Shusen; Wang, Chuan; Wu, Xinhong; Cheng, Jing; Li, Hui; Lin, Ying; Geng, Cuizhi; Gu, Kangsheng; Xie, Chunwei; Xiong, Huihua; Wu, Xiaohong; Yang, Junlan; Li, Qingshan; Chen, Yiding; Li, Fanfan; Zhang, Anqin; Zhang, Yongqiang; Wu, Yudong; Nie, Jianyun; Liu, Qiang; Wang, Kun; Mo, Xueli; Chen, Lilin; Pan, Yueyin; Fu, Peifen; Zhang, Helong; Pang, Danmei; Sheng, Yuan; Han, Yunwei; Wang, Hongxia; Cang, Shundong; Luo, Xianming; Yu, Wenbo; Deng, Rong; Yang, Chaoqiang; Keegan, Patricia
Source
Nature Medicine. 30(1):249-256
Subject
Language
English
ISSN
1078-8956
1546-170X
1546-170X
Abstract
The combination of immune-checkpoint blockade with chemotherapy for the first-line treatment of advanced triple-negative breast cancer (TNBC) has generated mixed results. TORCHLIGHT is a randomized, double-blinded phase 3 trial evaluating the efficacy and safety of first-line toripalimab and nab-paclitaxel (nab-P) (n = 353; experimental arm) versus placebo and nab-P (n = 178; control arm) for the treatment of women with metastatic or recurrent TNBC. The primary end point was progression-free survival (PFS) assessed by a blinded independent central review in the PD-L1-positive and intention-to-treat populations. The secondary end points included overall survival and safety. Overall, 200 and 100 patients, in the toripalimab and placebo arm respectively had PD-L1-positive TNBC. At the prespecified interim analysis, a statistically significant improvement in PFS assessed by a blinded independent central review was demonstrated in the experimental arm in the PD-L1-positive population (median PFS 8.4 versus 5.6 months; hazard ratio (HR) = 0.65, 95% confidence interval (CI) 0.470–0.906, P = 0.0102). The median overall survival was 32.8 versus 19.5 months (HR = 0.62, 95% CI 0.414–0.914, P = 0.0148). Similar incidences of treatment-emergent adverse events (AEs) (99.2% versus 98.9%), grade ≥3 treatment-emergent AEs (56.4% versus 54.3%) and fatal AEs (0.6% versus 3.4%) occurred in the experimental and control arms. The addition of toripalimab to nab-P provided a significant improvement in PFS for PD-L1-positive patients with metastatic or recurrent TNBC with an acceptable safety profile. ClinicalTrial.gov identifier NCT03777579.
In this prespecified analysis of the ongoing TORCHLIGHT phase 3 trial, first-line treatment with toripalimab and nab-paclitaxel in patients with advanced triple-negative breast cancer led to significantly longer progression-free survival in the PD-L1-positive population compared to nab-paclitaxel alone.
In this prespecified analysis of the ongoing TORCHLIGHT phase 3 trial, first-line treatment with toripalimab and nab-paclitaxel in patients with advanced triple-negative breast cancer led to significantly longer progression-free survival in the PD-L1-positive population compared to nab-paclitaxel alone.