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Camrelizumab combined with capecitabine and oxaliplatin followed by camrelizumab and apatinib as first-line therapy for advance
Esophageal or Gastric Cancer
Gastrointestinal (Noncolorectal) Cancer
2019 ASCO Annual Meeting
Author(s): Lin Shen, Zhi Peng, Yan-Qiao Zhang, Jia Wei, Feng Wang, Jieer Ying, Yanhong Deng, Kangsheng Gu, Ying Cheng, Xianglin Yuan, Juxiang Xiao, Linna Wang, Jianjun Zou; Beijing Cancer Hospital, Beijing, China; Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China; Department of Gastrointestinal Medical Oncology, Harbin Tumor Hospital, Harbin, China; The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, China; Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China; Department of Medical Oncology, The Sixth affiliated hospital of Sun Yat-Sen University, Guangzhou, China; Department of Oncology, The First Affiliated Hospital of Anhui Medical University, He Fei, China; Department of Oncology, Jilin Province Cancer Hospital, Changchun, China; Department of Cancer, Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China; Department of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, China; Jiangsu Hengrui Medicine Co. Ltd, Shanghai, China
Background: Capecitabine plus oxaliplatin (CAPOX) is one of the standard first-line treatments for advanced or metastatic gastric cancer. Camrelizumab (SHR-1210, an anti–PD-1 antibody) shows promising anti-tumor activity in patients (pts) with advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer. Camrelizumab combined with CAPOX for untreated G/GEJ cancer was assessed as a part of an ongoing multicenter, open-label phase 2 trial (cohort 1), and encouraging preliminary results were reported. Here, we present the updated safety and efficacy data. Methods: In this cohort, systemic treatment naïve pts with HER2– advanced or metastatic G/GEJ adenocarcinoma were given camrelizumab 200 mg on Day 1, capecitabine 1000 mg/m2 bid on Days 1–14 and oxaliplatin 130 mg/m2 on Day 1 of each 21-day-cycle for 4 to 6 cycles followed by camrelizumab 200 mg every 3 weeks plus apatinib 375 mg qd until disease progression or intolerable toxicity. The primary endpoint was objective response rate. Results: At data cutoff (Jan 20, 2019), 43 of the 48 enrolled pts were evaluable. Partial response was observed in 28 pts (65%), and 19 (44%) were confirmed. Stable disease in 14 pts and progressive disease in 10 pts were reported. Median estimates for duration of response and progression-free survival were not reached. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 9 pts (21%), included neutropenia, diarrhea, rash and elevated ALT, whereas none of the TRAEs was fatal. Ten pts without progression after 4–6 cycles of camrelizumab and CAPOX combination therapy all received camrelizumab plus apatinib as sequential therapy, and no new safety signals were observed. Conclusions: The updated results confirmed that camrelizumab plus CAPOX followed by camrelizumab plus apatinib was well tolerated with noteworthy responses as first-line therapy in advanced or metastatic G/GEJ cancer pts. Expansion of this cohort in a phase 3 study are under way. Clinical trial information: NCT03472365