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Camrelizumab Plus Carboplatin and Pemetrexed as First-line Treatment for Advanced Non-squamous NSCLC: Extended Follow-up of CameL Phase 3 Trial

Published:January 13, 2023DOI:https://doi.org/10.1016/j.jtho.2022.12.017
Camrelizumab Plus Carboplatin and Pemetrexed as First-line Treatment for Advanced Non-squamous NSCLC: Extended Follow-up of CameL Phase 3 Trial
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      Abstract

      Introduction

      In CameL phase 3 study (ClinicalTrials.gov, NCT03134872), addition of camrelizumab to first-line chemotherapy significantly improved the progression-free survival in patients with stage IIIB-IV non-squamous NSCLC. Here, we present outcomes after a minimum follow-up of 43.9 months since last patient randomization.

      Methods

      Eligible patients were randomized 1:1 to 4–6 cycles of camrelizumab plus carboplatin and pemetrexed or chemotherapy alone every 3 weeks, followed by maintenance camrelizumab plus pemetrexed or pemetrexed only (n=205 and 207, respectively). Total camrelizumab exposure was up to 2 years.

      Results

      As of January 31, 2022, camrelizumab plus chemotherapy exhibited substantially improved overall survival over chemotherapy alone (median, 27.1 versus 19.8 mo; hazard ratio, 0.72 [95% CI, 0.57–0.92]). In the chemotherapy alone group, 95 (45.9%) patients crossed over to camrelizumab monotherapy. After adjustment for crossover, the survival benefit with camrelizumab plus chemotherapy was more pronounced (adjusted hazard ratio, 0.55 [95% CI, 0.42–0.71]). In camrelizumab plus chemotherapy group, 33 patients completed 2 years of camrelizumab. Objective response rate was 97.0%, with ongoing responses in 17 of the 32 responses (53.1%); and 93.9% (31/33) of patients were alive at data cutoff. Safety profiles were consistent with the previous report, and no obvious evidence of cumulative toxicity was found with long exposure to camrelizumab.

      Conclusions

      Camrelizumab plus carboplatin and pemetrexed provides long-term survival benefit over chemotherapy, with manageable toxicity, as well as remarkable and durable response in patients receiving 2 years of camrelizumab, further supporting camrelizumab combination as first-line treatment for advanced non-squamous NSCLC.

      Keywords

      Article info

      Publication history

      Accepted: December 26, 2022
      Received in revised form: December 21, 2022
      Received: November 11, 2022

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      Declaration of interests

      Caicun Zhou has received payments or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Amoy Diagnostics, Boehringer Ingelheim, C-Stone, Hengrui, Innovent Biologics, Lilly China, LUYE Pharma, Merck Sharp & Dohme, Qilu, Roche, Sanofi, and TopAlliance Biosciences Inc.; and is on data safety monitoring boards or advisory boards for Hengrui, Innovent Biologics, Qilu, and TopAlliance Biosciences Inc. Yanfei Tai, Xinjing Ma, and Wei Shi are employees of Hengrui. The remaining authors declare no conflict of interest.

      Funding

      This study was funded by Jiangsu Hengrui Pharmaceuticals, which participated in study design, data collection, and data interpretation. This study was also supported, in part, by grants from the Shanghai Municipal Health Commission Collaborative Innovation Cluster Program (No. 2020CXJQ02) and the National Natural Science Foundation of China (No. 82141101). We are grateful to all patients and their families and all members of the collaborative group. Statistical analyses were provided by PAREXEL International (funded by Hengrui) and medical writing assistance was provided by Dr. Hui Dong for (Medical Writer at Hengrui).

      CRediT Statement

      Caicun Zhou: Conceptualization; Data curation; Formal analysis; Funding acquisition; Investigation; Project administration; Resources; Supervision; Validation; Writing - original draft; Writing - review & editing.

      Gongyan Chen, Yunchao Huang, Jianying Zhou, LiZhu Lin, Jifeng Feng, Zhehai Wang, Yongqian Shu, Jianhua Shi, Yi Hu, QiMing Wang, Ying Cheng, Fengying Wu, Jianhua Chen, Xiaoyan Lin, Yongsheng Wang, Jianan Huang, Jiuwei Cui, Lejie Cao, Yunpeng Liu, Yiping Zhang, Yueyin Pan, Jun Zhao, LiPing Wang, Jianhua Chang, Qun Chen, Xiubao Ren, Wei Zhang, Yun Fan, Zhiyong He, Jian Fang, Kangsheng Gu, XiaoRong Dong, Faguang Jin, Hongjun Gao, Guangyu An, Cuimin Ding, Xiaodong Jiang, Jianping Xiong, Xiangdong Zhou, Sheng Hu, Ping Lu, Anwen Liu, Shuliang Guo, Jianjin Huang, Chengchu Zhu, Jian Zhao, Beili Gao, Yinglan Chen, Chengping Hu, Jian Zhang, Hongmei Zhang, Hui Zhao: Data curation; Investigation; Project administration; Resources; Writing - review & editing.

      Yanfei Tai: Resources; Software; Supervision; Validation; Visualization; Writing - review & editing.

      Xinjing Ma: Resources; Software; Supervision; Validation; Writing - review & editing.

      Wei Shi: Project administration; Resources; Software; Supervision; Validation; Writing - review & editing.

      Identification

      DOI: https://doi.org/10.1016/j.jtho.2022.12.017

      Copyright

      © 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

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