Meeting
2023 ASCO Annual Meeting
TORCHLIGHT: A randomized, double-blind, phase III trial of toripalimab versus placebo, in combination with nab-paclitaxel(nab-P) for patients with metastatic or recurrent triple-negative breast cancer (TNBC).
Authors
Zefei Jiang
Department of oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China
Zefei Jiang , Quchang Ouyang , Tao Sun , Qingyuan Zhang , Yuee Teng , Jiuwei Cui , Haibo Wang , Yongmei Yin , Xiaojia Wang , Xin Zhou , Yongsheng Wang , Gang Sun , Jingfen Wang , Lili Zhang , Jin Yang , Jun Qian , Tienan Yi , Min Yan , Xinlan Liu
Organizations
Department of oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China, Department of Breast Medicine, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China, Department of Breast Medicine, Cancer Hospital of China Medical University, Cancer Hospital of Dalian University of Technology, Liaoning Cancer Hospital and Institute, Shenyang, China, China, Harbin Medical University Cancer Hospital, Harbin, China, Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China, China, Department of Medical Oncology, the First Bethune Hospital of Jilin University, Changchun, China, Breast Center, The Affiliated Hospital of Qingdao University Medical College, Qingdao, China, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China, Department of Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences/Zhejiang Cancer Hospital, Institute of Cancer and Basic Medicine, Chinese Academy of Sciences, Hangzhou, China, Chongqing Cancer Hospital, Chongqing, China, Shandong Cancer Hospital, Shandong University, Jinan, China, The Affiliated Cancer Hospital of Xinjiang Medical University, Xinjiang Cancer Center, Key Laboratory of Oncology of Xinjiang Uyghur Autonomous Region, Urumqi, China, Department II of breast, Linyi Cancer Hospital, Linyi, China, Jiangsu Cancer Hospital, Nanjing, China, The first affiliated hospital of Xi'an Jiaotong University, Xi'an, China, The first affiliated hospital of bengbu medical college, Bengbu, China, Xiangyang Central Hospital, Xiangyang, China, Henan Cancer Hospital, Zhengzhou, China, Departments of Oncology, General Hospital of Ningxia Medical University, Yinchuan, China
Research Funding
Pharmaceutical/Biotech Company
Shanghai Junshi Biosciences Co., Ltd.
Background: Checkpoint blockade combined with taxanes based chemotherapy had generated mixed results as first line treatment for metastatic TNBC. Toripalimab, a humanized IgG4K monoclonal antibody specific for PD-1, provided significant clinical efficacy with a favorable safety profile in various solid tumors. The purpose of this study is to compare the efficacy and safety of toripalimab versus placebo, in combination with nab-P for metastatic or recurrent TNBC (NCT04085276). Methods: Patients with initially diagnosed metastatic or recurrent inoperable TNBC were randomized 2:1 to receive toripalimab (240mg, D1, q3w) or placebo along with nab-P on days1, 8 in 3-week cycles. Stratifications included PD-L1 expression, paclitaxel therapy history and line of prior therapy at enrollment. Primary endpoint was progression-free survival (PFS) assessed by a blinded independent central review (BICR) per RECIST v1.1, first in the PD-L1-positive population and then in the ITT population. Secondary endpoints included overall survival (OS) and safety. Results: 531 patients were randomized to toripalimab (n = 353) or placebo (n = 178); 200 and 100 patients, respectively had PD-L1 positive TNBC. At interim analysis, with the median follow-up of 14 months, a statistically significant improvement in PFS by BICR was demonstrated for the toripalimab arm in the PD-L1 positive subgroup (mPFS 8.4 vs 5.6 months; HR = 0.653, 95% CI 0.470-0.906, P = 0.0102). The PFS in the ITT population showed a similar trend (mPFS 8.4 vs 6.9 months, HR = 0.773, 95%CI 0.602-0.994). Descriptive analysis of OS showed a trend towards improved OS in the PD-L1 positive (mOS 32.8 vs 19.5 months; HR = 0.615, 95%CI 0.414-0.914) and the ITT population (mOS 33.1 vs 23.5 months; HR = 0.691, 95% CI 0.513-0.932). No new safety signals were identified. Grade≥3 adverse events (AEs) (56.4% vs 54.3%) and fatal AEs (0.6% vs 3.4%) were similar between arms, while AEs leading to discontinuation of toripalimab/placebo (8.5% vs. 3.4%) and immune-related (irAEs) (40.8% vs. 24.0%) were more frequent in the toripalimab arm. Conclusions: The addition of toripalimab to nab-P provided a significant improvement in PFS for PD-L1 positive metastatic or recurrent TNBC patients receiving first-line treatment with an acceptable safety profile. Patients will be followed for the final PFS and OS analysis. Clinical trial information: NCT04085276.
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Abstract Details
Session Type
Rapid Oral Abstract Session
Session Title
Breast Cancer
Track
Breast Cancer
Sub Track
Triple-Negative
Clinical Trial Registration Number
NCT04085276
Citation
J Clin Oncol 41, 2023 (suppl 17; abstr LBA1013)
DOI
10.1200/JCO.2023.41.17_suppl.LBA1013
Abstract #
LBA1013
Abstract Disclosures
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