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

doi:10.1159/000516470

A Phase 2 Study of Camrelizumab for Advanced Hepatocellular Carcinoma: Two-Year Outcomes and Continued Treatment beyond First RECIST-Defined Progression

Liver Cancer. 2021 Jun 30;10(5):500-509. doi: 10.1159/000516470. eCollection 2021 Sep.

Authors

Zhenggang Ren¹, Shukui Qin², Zhiqiang Meng³, Zhendong Chen⁴, Xiaoli Chai⁵, Jianping Xiong⁶, Yuxian Bai⁷, Lin Yang⁸, Hong Zhu⁹, Weijia Fang¹⁰, Xiaoyan Lin¹¹, Xiaoming Chen¹², Enxiao Li¹³, Linna Wang¹⁴, Ping Yan¹⁴, Jianjun Zou¹⁴

Affiliations

¹ Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China.
² Department of Medical Oncology Center, Bayi Affiliated Hospital, Nanjing University of Chinese Medicine, Nanjing, China.
³ Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, China.
⁴ Department of Medical Oncology, Second Hospital of Anhui Medical University, Hefei, China.
⁵ Department of Intervention, Hunan Cancer Hospital, Changsha, China.
⁶ Department of Medical Oncology, First Affiliated Hospital of Nanchang University, Nanchang, China.
⁷ Department of Medical Oncology, Third Affiliated Hospital of Harbin Medical University, Harbin, China.
⁸ Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
⁹ Department of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China.
¹⁰ Department of Medical Oncology, First Affiliated Hospital of Zhejiang University (School of Medicine), Hangzhou, China.
¹¹ Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, China.
¹² Department of Interventional Radiology, Cancer Center, Guangdong Provincial People's Hospital, Guangzhou, China.
¹³ Department of Medical Oncology, First Affiliated Hospital of Xi'an Jiaotong University (School of Medicine), Xi'an, China.
¹⁴ Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.

Abstract

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.

Keywords: Camrelizumab; Hepatocellular carcinoma; Long-term follow-up.