Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer

Yunpeng Yang; Bin Wu; Linian Huang; Meiqi Shi; Yunpeng Liu; Yanqiu Zhao; Lijun Wang; Shun Lu; Gongyan Chen; Baolan Li; Conghua Xie; Jian Fang; Nong Yang; Yiping Zhang; Jiuwei Cui; Yong Song; Cuiying Zhang; Xiaodong Mei; Bangwei Cao; Lan Yang; Ying Cheng; Kejing Ying; Tao Sun; Biyong Ren; Qitao Yu; Zijun Liao; Zhidong Pei; Mengzhao Wang; Jianying Zhou; Shiying Yu; Guosheng Feng; Huiping Wan; Huaqing Wang; Shegan Gao; Jinliang Wang; Guangyu An; Yi Geng; Yanxia Ji; Ying Yuan; Shenglin Ma; Zhongyao Jia; Mu Hu; Hui Zhou; Jie Yu; Xing Sun; Li Zhang

doi:10.21037/tlcr.2019.12.23

Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer

Transl Lung Cancer Res. 2019 Dec;8(6):989-999. doi: 10.21037/tlcr.2019.12.23.

Authors

Yunpeng Yang¹, Bin Wu², Linian Huang³, Meiqi Shi⁴, Yunpeng Liu⁵, Yanqiu Zhao⁶, Lijun Wang⁷, Shun Lu⁸, Gongyan Chen⁹, Baolan Li¹⁰, Conghua Xie¹¹, Jian Fang¹², Nong Yang¹³, Yiping Zhang¹⁴, Jiuwei Cui¹⁵, Yong Song¹⁶, Cuiying Zhang¹⁷, Xiaodong Mei¹⁸, Bangwei Cao¹⁹, Lan Yang²⁰, Ying Cheng²¹, Kejing Ying²², Tao Sun²³, Biyong Ren²⁴, Qitao Yu²⁵, Zijun Liao²⁶, Zhidong Pei²⁷, Mengzhao Wang²⁸, Jianying Zhou²⁹, Shiying Yu³⁰, Guosheng Feng³¹, Huiping Wan³², Huaqing Wang³³, Shegan Gao³⁴, Jinliang Wang³⁵, Guangyu An³⁶, Yi Geng³⁷, Yanxia Ji³⁸, Ying Yuan³⁹, Shenglin Ma⁴⁰, Zhongyao Jia⁴¹, Mu Hu⁴², Hui Zhou⁴³, Jie Yu⁴³, Xing Sun⁴³, Li Zhang¹

Affiliations

¹ Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou 510000, China.
² Department of Respiratory Medicine, Affiliated Hospital of Guangdong Medical University, Zhanjiang 524002, China.
³ Department of Respiratory Medicine, The First Affiliated Hospital of Bengbu Medical College, Bangbu 233000, China.
⁴ Department of Oncology, Jiangsu Cancer Hospital, Nanjing 210009, China.
⁵ Department of Oncology, The First Hospital of China Medical University, Shenyang 110001, China.
⁶ Department of Respiratory Medicine, Henan Cancer Hospital, Zhengzhou 450003, China.
⁷ Department of Tumor radiotherapy, The Second Affiliated Hospital of Xingtai Medical College, Xingtai 054000, China.
⁸ Department of Oncology, Shanghai Chest Hospital, Shanghai 200030, China.
⁹ Department of Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China.
¹⁰ General Department, Beijing Chest Hospital, Capital Medical University, Beijing 101149, China.
¹¹ Department of Oncology, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.
¹² Department of Oncology, Peking University Cancer Hospital, Beijing 100142, China.
¹³ Department of Pulmonary Gastroenterology, Hunan Cancer Hospital, Changsha 410006, China.
¹⁴ Department of Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China.
¹⁵ Department of Oncology, The First Hospital of Jilin University, Changchun 130000, China.
¹⁶ Department of Respiratory Medicine, General Hospital of Eastern Theater Command, Nanjing 210002, China.
¹⁷ Department of Oncology, Inner Mongolia People's Hospital, Hohhot 010017, China.
¹⁸ Department of Respiratory Medicine, An Hui Provincial Hospital, Hefei 230000, China.
¹⁹ Department of Oncology, Peking Friendship Hospital, Capital Medical University, Beijing 100050, China.
²⁰ Department of Respiratory Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
²¹ Department of Oncology, Jilin Cancer Hospital, Changchun 130000, China.
²² Department of Respiratory Medicine, Sir Run Shaw Hospital of Zhejiang University School of Medicine, Hangzhou 310016, China.
²³ Department of Internal Medicine, Liaoning Cancer Hospital & Institute, Shenyang 110046, China.
²⁴ Department of Respiratory Medicine, Chongqing three Gorges Central Hospital, Chongqing 404000, China.
²⁵ Department of Oncology, The Cancer Hospital of Guangxi Zhuang Autonomous Region, Nanning 530000, China.
²⁶ Department of Internal Medicine, Shaanxi Provincial Tumor Hospital, Xi'an 710061, China.
²⁷ Department of Oncology, Luoyang Central Hospital Affiliated To Zhengzhou University, Luoyang 471009, China.
²⁸ Department of Respiratory Medicine, Peking Union Medical College Hospital, Beijing 100005, China.
²⁹ Department of Respiratory Medicine, The First Affiliated Hospital Zhejiang University, Hangzhou 310003, China.
³⁰ Department of Oncology, Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, China.
³¹ Department of Chemotherapy, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning 530000, China.
³² Department of Oncology, Jiangxi People's Hospital, Nanchang 330000, China.
³³ Department of Oncology, Tianjin People's Hospital, Tianjin 300121, China.
³⁴ Department of Oncology, First Affiliated Hospital of Henan University of Science and Technology, Luoyang 471000, China.
³⁵ Department of Oncology, General Hospital of PLA, Beijing 100853, China.
³⁶ Department of Oncology, Beijing Chao-Yang Hospital, Beijing 100020, China.
³⁷ Department of Oncology, Baoji Central Hospital, Baoji 721008, China.
³⁸ Department of Oncology, Handan Central Hospital, Handan 056001, China.
³⁹ Department of Oncology, The Second Affiliated Hospital Zhejiang University, Hangzhou 310009, China.
⁴⁰ Department of Oncology, Hangzhou First People's Hospital, Hangzhou 310002, China.
⁴¹ Department of Oncology, Linyi People's Hospital, Linyi 276003, China.
⁴² Department of Chest Surgery, Xuanwu Hospital Capital Medical University, Beijing 100053, China.
⁴³ Innovent Biologics, Inc., Suzhou 215123, China.

Abstract

Background: Bevacizumab is a monoclonal antibody (mAb) against vascular endothelial growth factor (VEGF) and used for treatments of various cancers. Due to the high costs of bevacizumab treatments, a biosimilar provides an affordable alternative therapy for cancer patients.

Methods: In this randomized, double-blind, multicenter, phase 3 study, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) patients with wild-type epidermal growth factor receptor were enrolled and randomized (1:1) into IBI305 or bevacizumab groups. Patients received 6 cycles of paclitaxel/carboplatin plus IBI305 or bevacizumab 15 mg/kg intravenously followed by IBI305 or bevacizumab 7.5 mg/kg maintenance until disease progression, unacceptable toxicity or death. The primary endpoint was confirmed objective response rate (ORR) by an independent radiological review committee (IRRC) and secondary endpoints included disease control rate (DCR), progression-free survival (PFS), duration of response (DOR), overall survival (OS) and safety.

Results: A total of 450 NSCLC patients were enrolled (224 in IBI305 group and 226 in bevacizumab group). ORRs were 44.3% for IBI305 and 46.4% for bevacizumab, and the ORR ratio was 0.95 (90% CI: 0.803 to 1.135), within the predefined equivalence margin of 0.75 to 1.33. No significant difference in PFS (7.64 vs. 7.77 m, P=0.9987) was observed between the 2 groups. Serious adverse events (AEs) occurred in 33.5% (75/224) of patients in the IBI305 group and 37.6% (85/226) in the bevacizumab group. AEs ≥ grade 3 were similar in the IBI305 and bevacizumab groups [84.4% (189/224) vs. 89.8% (203/226), P=0.085].

Conclusions: IBI305 is similar to bevacizumab in terms of efficacy and safety.

Trial registration: Clinicaltrials.org Identifier: NCT02954172. Registered on 3 November 2016. Https://clinicaltrials.gov/.

Keywords: Bevacizumab; IBI305; biosimilar; non-small cell lung cancer (NSCLC); vascular endothelial growth factor (VEGF).

Associated data

ClinicalTrials.gov/NCT02954172