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Attend this session at the
2019 ASCO Annual Meeting!

Session: Lung Cancer—Non-Small Cell Metastatic

Type: Poster Session

Time: Sunday June 2, 8:00 AM to 11:00 AM

Location: Hall A

Efficacy of PD-1 monoclonal antibody SHR-1210 plus apatinib in patients with advanced nonsquamous NSCLC with wild‐type EGFR and ALK.

Metastatic Non-Small Cell Lung Cancer

Lung Cancer—Non-Small Cell Metastatic

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #435)

J Clin Oncol 37, 2019 (suppl; abstr 9112)

Author(s): Caicun Zhou, Guanghui Gao, Yi Na Wang, Jun Zhao, Gongyan Chen, Zhihua Liu, Kangsheng Gu, Meijuan Huang, Jianxing He, Jianhua Chen, Zhiyong Ma, Ji Feng Feng, Jianhua Shi, Quanren Wang, Ying Yang, Xinmin Yu, Ying Cheng, Yu Yao, Shengxiang Ren; Pulmonary Hospital of Tongji University, Shanghai, China; Shanghai Pulmonary Hospital, Shanghai, China; Thoracic Oncology Department, The First Affiliated Hospital Zhejiang University, Hangzhou, China; Beijing Cancer Hospital, Beijing, China; Harbin Medical University Cancer Hospital, Harbin, China; Jiangxi Cancer Hospital, Nanchang, China; Department of Oncology, The First Affiliated Hospital of Anhui Medical University, He Fei, China; Department of Thoracic Cancer, Cancer Center, West China Hospital, Sichuan Univeristy, Chengdu, China; The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China; Hunan Cancer Hospital, Changsha, China; The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China; Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research and Nanjing Medical University Affiliated Cancer Hospital, Jiangsu, China; Shandong Linyi Tumor Hospital, Linyi, China; Jiangsu HengRui Medicine Co., Ltd., Shanghai, China; BGI Genomics, Tianjin, China; Zhejiang Cancer Hospital, Hangzhou, China; Department of Oncology, Jilin Province Cancer Hospital, Changchun, China; Department of medical Oncology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi‘’an, China; Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China

Abstract Disclosures


Background: Our preclinical study suggested combination of PD-1 monoclonal antibody SHR-1210 and VEGFR 2 inhibitor apatinib significantly improved antitumor effects. This was an open-label, multi-center, phase 1/2 study of intravenous SHR-1210 plus oral apatinib in patients with advanced NSCLC. Here, we reported preliminary efficacy and safety outcomes of SHR-1210 plus apatinib in patients with wild‐type EGFR and ALK. Methods: In dose-escalation phase, advanced non-squamous NSCLC patients (pts) previously treated with at least 2nd line chemotherapy were enrolled to explore 2 dose levels of apatinib (250, 375mg/d) + SHR-1210 (200mg, q2w). 250mg/d of apatinib was selected to be combined with SHR-1210 in phase II trial. Pts previously treated with 1st line platinum-based chemotherapy were enrolled. Primary endpoint was ORR per RECIST 1.1. Archived or fresh tumor tissues and blood samples were taken before the treatment, PD-L1 expression and tumor mutation burden (TMB) were tested and correlated with efficacy. TMB was detected by Oseq-pan cancer panel (including 636 genes and 1.95Mb), and then calculated by in-house algorithm developed by BGI Genomics Co., Ltd. Results: 96 pts with advanced non-squamous NSCLC harboring wild‐type EGFR and ALK were recruited. 23 had ≥2 prior lines of systemic treatment, and 73 had 1 prior line of treatment. Median age was 57, male 79.8%, adenocarcinoma 93.9%, ex-smokers 56.7%. ORR and DCR in 91evaluable pts were 29.7% and 81.3%, respectively. Blood TMB (bTMB) test was available in 80/91 evaluable patients and the cut-point was 1.54 muts/Mb as determined by receiver operating characteristic curve. ORR in pts with high bTMB was 50% (19/38). At data cutoff of 20 Jan 2019, 20/27 responders were still on treatment (table). Across all 96pts, 54(56.2%) grade ≥3 TRAEs. AEs of grade ≥3 occurring in 2 or more pts included hypertension, hand-foot syndrome, gamma-glutamyl transferase increase, proteinuria, abnormal hepatic function and alkaline phosphatase increase. Conclusions: SHR-1210 plus apatinib demonstrated promising anti-tumor activity with acceptable safety in patients with non-squamous NSCLC, especially in those with high bTMB. Prospective study is needed to validate the clinical outcome and bTMB as a predictor of efficacy. Clinical trial information: NCT03083041

ORRDCRmDOR (mos)mPFS (mos)
≥2 prior lines33.3%85.7%5.9
3/7 ongoing
1 prior lines28.6%80.0%NR
17/20 ongoing
14/19 ongoing
5/7 ongoing

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