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. 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.
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.
Authors: Lesley Seymour; Jan Bogaerts; Andrea Perrone; Robert Ford; Lawrence H Schwartz; Sumithra Mandrekar; Nancy U Lin; Saskia Litière; Janet Dancey; Alice Chen; F Stephen Hodi; Patrick Therasse; Otto S Hoekstra; Lalitha K Shankar; Jedd D Wolchok; Marcus Ballinger; Caroline Caramella; Elisabeth G E de Vries Journal: Lancet Oncol Date: 2017-03-02 Impact factor: 41.316
Authors: Richard S Finn; Shukui Qin; Masafumi Ikeda; Peter R Galle; Michel Ducreux; Tae-You Kim; Masatoshi Kudo; Valeriy Breder; Philippe Merle; Ahmed O Kaseb; Daneng Li; Wendy Verret; Derek-Zhen Xu; Sairy Hernandez; Juan Liu; Chen Huang; Sohail Mulla; Yulei Wang; Ho Yeong Lim; Andrew X Zhu; Ann-Lii Cheng Journal: N Engl J Med Date: 2020-05-14 Impact factor: 91.245
Authors: Andrew X Zhu; Richard S Finn; Julien Edeline; Stephane Cattan; Sadahisa Ogasawara; Daniel Palmer; Chris Verslype; Vittorina Zagonel; Laetitia Fartoux; Arndt Vogel; Debashis Sarker; Gontran Verset; Stephen L Chan; Jennifer Knox; Bruno Daniele; Andrea L Webber; Scot W Ebbinghaus; Junshui Ma; Abby B Siegel; Ann-Lii Cheng; Masatoshi Kudo Journal: Lancet Oncol Date: 2018-06-03 Impact factor: 41.316
Authors: Robert L Ferris; George Blumenschein; Jerome Fayette; Joel Guigay; A Dimitrios Colevas; Lisa Licitra; Kevin Harrington; Stefan Kasper; Everett E Vokes; Caroline Even; Francis Worden; Nabil F Saba; Lara C Iglesias Docampo; Robert Haddad; Tamara Rordorf; Naomi Kiyota; Makoto Tahara; Manish Monga; Mark Lynch; William J Geese; Justin Kopit; James W Shaw; Maura L Gillison Journal: N Engl J Med Date: 2016-10-08 Impact factor: 91.245