A Phase 2 Study of Camrelizumab for Advanced Hepatocellular Carcinoma: Two-Year Outcomes and Continued Treatment beyond First RECIST-Defined Progression
Zhenggang Ren,
Shukui Qin,
Zhiqiang Meng,
Zhendong Chen,
Xiaoli Chai,
Jianping Xiong,
Yuxian Bai,
Lin Yang,
Hong Zhu,
Weijia Fang,
Xiaoyan Lin,
Xiaoming Chen,
Enxiao Li,
Linna Wang,
Ping Yan,
Jianjun Zou
Affiliations
Zhenggang Ren
Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China
Shukui Qin
Department of Medical Oncology Center, Bayi Affiliated Hospital, Nanjing University of Chinese Medicine, Nanjing, China
Zhiqiang Meng
Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, China
Zhendong Chen
Department of Medical Oncology, Second Hospital of Anhui Medical University, Hefei, China
Xiaoli Chai
Department of Intervention, Hunan Cancer Hospital, Changsha, China
Jianping Xiong
Department of Medical Oncology, First Affiliated Hospital of Nanchang University, Nanchang, China
Yuxian Bai
Department of Medical Oncology, Third Affiliated Hospital of Harbin Medical University, Harbin, China
Lin Yang
Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Hong Zhu
Department of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China
Weijia Fang
Department of Medical Oncology, First Affiliated Hospital of Zhejiang University (School of Medicine), Hangzhou, China
Xiaoyan Lin
Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, China
Xiaoming Chen
Department of Interventional Radiology, Cancer Center, Guangdong Provincial People’s Hospital, Guangzhou, China
Enxiao Li
Department of Medical Oncology, First Affiliated Hospital of Xi’an Jiaotong University (School of Medicine), Xi’an, China
Linna Wang
Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China
Ping Yan
Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China
Jianjun Zou
Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China
Introduction: In a multicenter, open-label, parallel-group, randomized, phase 2 study for pretreated advanced hepatocellular carcinoma (HCC), camrelizumab showed potent antitumor activity and acceptable safety profile. The aim of this report was to provide long-term data and evaluate potential benefit of treatment with camrelizumab beyond progression. Methods: From November 15, 2016, to November 16, 2017, 217 patients received camrelizumab 3 mg/kg intravenously every 2 or 3 weeks. Treatment beyond first Response Evaluation Criteria in Solid Tumors (RECIST)-defined progression (TBP) with camrelizumab was allowed. Results: At data cutoff of December 16, 2019 (>2 years after the last patient enrollment; median duration of follow-up, 13.2 months [IQR 5.7–25.8]), 14 (43.8%) of the 32 responses per blinded independent central review were ongoing. The median duration of response was not reached (range 2.5–30.5 + months). The ongoing response rates at 12, 18, and 24 months were 68.3% (95% confidence interval [CI] 47.7–82.2), 59.8% (95% CI 38.8–75.6), and 53.1% (95% CI 31.0–71.0), respectively. The median overall survival (OS) was 14.2 months (95% CI 11.5–16.3). The 18- and 24-month OS rates were 41.3% (95% CI 34.6–47.9) and 33.7% (95% CI 27.3–40.2), respectively. Of the 172 patients who experienced RECIST-defined progression per investigator, 102 received TBP, while 70 did not (non-TBP). The median OS was 16.9 months (95% CI 13.3–22.6) in the TBP group versus 9.4 months (95% CI 5.8–14.8) in the non-TBP group, and the 18- and 24-month OS rates were 47.5% (95% CI 37.3–56.9) versus 33.1% (95% CI 22.3–44.3) and 38.8% (95% CI 29.2–48.4) versus 23.2% (95% CI 13.8–34.1), respectively. No new safety signals of camrelizumab were observed. Conclusions: With prolonged follow-up, camrelizumab continues to demonstrate the durable response and long survival in pretreated advanced HCC patients with manageable toxicities, especially in those who continued the treatment beyond first RECIST-defined progression.
