A phase 2, open-label, multicenter study to evaluate the efficacy, safety, and tolerability of KN046 in combination with chemotherapy in subjects with advanced non-small cell lung cancer.

作者：Yunpeng Yang, Wenfeng Fang, Yan Huang, Xingya Li, Siyuan Huang, Jingxun Wu, Yibin Li, Baoping Chang, Sheng Hu, Shujun Yang, June Xu, Hardy Van, Lihua Zhi, Yue Xia, Fei Yang, Yi Xia, Paul Kong, Wei Dong, Ting Xu, Li Zhang · 发表于：Journal of Clinical Oncology · 年份：2021 · DOI：10.1200/jco.2021.39.15_suppl.9060 · 被引用次数：9 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Research Studies、Peptidase Inhibition and Analysis

9060 Background: Dual blockade of PD-1 and CTLA-4 has shown improved overall survival (OS) in combination with a short course of chemotherapy. KN046 is a novel bispecific antibody that blocks both PD-L1 interaction with PD-1/CD80 and CTLA-4 interaction with CD80/CD86. We hypothesized that KN046 could be combined with a full course of chemotherapy and build more durable clinical benefit. Methods: This study enrolled systemic treatment naive, stage IV NSCLC patients (pts). Eligible pts received KN046 plus platinum doublet chemotherapy until progressive disease, unacceptable toxicity, withdrawal of informed consent or death. Efficacy evaluation was performed by investigators per RECIST 1.1. Safety and tolerability were assessed per NCI-CTCAE v5.0. Results: As of the Jan. 19, 2021, 87 pts [Cohort 1 (n = 51), Cohort 2 (n = 36)] have been enrolled with 83 pts having tumor PD-L1 expression data (PD-L1 ≥1%: 55.4%; PD-L1 < 1%: 44.6%). 33.3% pts remained on the study treatment and 66.7% pts discontinued treatment due to disease progression (27.6%), TEAE (13.8%), death (9.2%) and other reasons (16%). The median treatment duration of KN046 was 21 weeks (range: 1.6̃68.7 weeks). Treatment related TEAE (TRAE) occurred in 92% pts. 25.3% pts experienced Grade≥3 TRAE [diarrhoea (5.7%), alanine aminotransferase increased (4.6%), infusion related reaction (3.4%), rash (3.4%), aspartate aminotransferase increased, dermatitis allergic and immune-mediated pneumonitis (2.3%, respectively), anaphy...