Real world experience with camrelizumab in patients with advanced non-small cell lung cancer: a prospective multicenter cohort study (NOAH-LC-101)

Rong Wang; Meiqi Shi; Mei Ji; Zhengxiang Han; Lingxiang Chen; Yong Liu; Kaihua Lu; Lianke Liu; Bi Chen; Xizhi Zhang; Liyun Miao; Yongqian Shu

doi:10.21037/tlcr-23-121

Real world experience with camrelizumab in patients with advanced non-small cell lung cancer: a prospective multicenter cohort study (NOAH-LC-101)

Transl Lung Cancer Res. 2023 Apr 28;12(4):786-796. doi: 10.21037/tlcr-23-121. Epub 2023 Apr 25.

Authors

Rong Wang¹, Meiqi Shi², Mei Ji³, Zhengxiang Han⁴, Lingxiang Chen², Yong Liu⁵, Kaihua Lu¹, Lianke Liu¹, Bi Chen⁶, Xizhi Zhang⁷, Liyun Miao⁸, Yongqian Shu¹

Affiliations

¹ Department of Oncology, Jiangsu Province Hospital, Nanjing, China.
² Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, China.
³ Department of Oncology, The First People's Hospital of Changzhou, Changzhou, China.
⁴ Department of Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
⁵ Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou, China.
⁶ Department of Respiratory Medicine, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
⁷ Department of Oncology, Northern Jiangsu People's Hospital, Yangzhou, China.
⁸ Department of Respiratory Medicine, Nanjing Drum Tower Hospital, Nanjing, China.

Abstract

Background: Camrelizumab has shown promising survival benefits in treatment-naïve advanced non-small cell lung cancer (NSCLC) patients when used in combination with chemotherapy. However, its effectiveness and safety outside the clinical trial setting are largely unknown. Therefore, we conducted NOAH-LC-101, a prospective multicenter cohort study, to investigate the real-world effectiveness and safety of camrelizumab on a large cohort of advanced NSCLC patients in daily clinical practice.

Methods: All consecutive patients aged ≥18 years with confirmed advanced NSCLC scheduled for camrelizumab treatment were screened for inclusion at 43 hospitals in China. The primary outcome was progression-free survival (PFS). The secondary outcomes included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.

Results: Between August 2019 and February 2021, 403 patients were included. The median age of participants was 65 years (range, 27-87 years). There were 57 (14.1%) participants with an Eastern Cooperative Oncology Group performance status (ECOG PS) of ≥2. Most participants received camrelizumab in the second or later lines (68.7%) and plus chemotherapy (64.8%). The median PFS was 12.6 [95% confidence interval (CI): 10.7-17.0] months and median OS was 22.3 months [95% CI: 19.3-not reached (NR)]. The ORR was 28.8% (95% CI: 24.4-33.5%) and DCR was 79.9% (95% CI: 75.7-83.7%). Adverse events of any grade occurred in 348 (86.4%) participants. No new safety signals were identified. Reactive cutaneous capillary endothelial proliferation was observed in 75 (18.6%) patients, all of which were grade 1-2.

Conclusions: This study demonstrates the effectiveness and safety of camrelizumab in a large sample of real-world NSCLC patients. The results are generally consistent with those previously reported in pivotal clinical trials. This study supports the clinical use of camrelizumab in a broader patient population (ChiCTR1900026089).

Keywords: Non-small cell lung cancer (NSCLC); anti-PD-1; camrelizumab; real world.