Abstract and Introduction
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).
Introduction
Although lung cancer has been re-ranked as the second most commonly diagnosed cancer, it has remained the leading cause of cancer death globally, with an estimated 2.2 million new cases and 1.8 million deaths in 2020.[1] As the major histological subtype, non-small cell lung cancer (NSCLC) accounts for 85% of all lung cancer cases. According to the latest cancer statistics in 2021, the mortality of patients with NSCLC has fallen sharply during the last decade, along with the steady decline in the incidence.[2] The same trend was observed in the United States. The decreased mortality has been partially ascribed to treatment advances, particularly the successful application of targeted therapies.[3]
In China, lung cancer currently ranks first in cancer burden and mortality.[4] According to professor Chen from the National Cancer Center, China has been undergoing a cancer-related transition with an increasing burden of lung cancer and other cancers. Both the incidence and mortality of lung cancer showed an increasing trend between 2015 and 2020, with an estimated 0.79 and 0.82 million new cases and 0.63 and 0.72 million deaths, respectively.[5] Novel treatment strategies are urgently needed to address the increasing tumor burden.
As a promising approach for targeting cancer, immunotherapy has revolutionized the treatment scenario for various cancers and become the fourth pillar for clinical cancer care. Although NSCLC was thought to have poor immunogenicity, it has consistently shown a high response to immune checkpoint inhibitors (ICIs), such as anti-programmed cell death 1 (PD-1) or its ligand (PD-L1) antibodies.[6] Numerous anti-PD-1/PD-L1 inhibitors (e.g., pembrolizumab, nivolumab, atezolizumab, camrelizumab) are currently approved or their approval is underway for treatment of NSCLC in China.[7] Camrelizumab is a Chinese developed humanized anti-PD-1 monoclonal antibody. It was firstly approved by the National Medical Products Administration (NMPA) for the treatment of relapsed or refractory classical Hodgkin lymphoma in 2019.[8] Since then, 7 new indications have been approved in China for the treatment of various solid tumors, including NSCLC. The approvals of camrelizumab for treatment of NSCLC were based primarily on the clinically meaningful improvement in progression-free survival (PFS) in 2 randomized multicenter phase III trials, the CameL and CameL-sq trials.[9,10] Regrettably, traditional trials are generally conducted in a stringent research setting and a significant proportion of patients presenting in daily life are usually excluded or under-represented. Limited data are available on the effectiveness and safety of camrelizumab in NSCLC patients treated in daily clinical practice, especially those with older age, poor performance, or metastatic diseases (brain, liver, and adrenal gland).
To bridge the data gap, the present study was prospectively designed to investigate the real-world effectiveness and safety of camrelizumab using a larger number of advanced NSCLC patients than in previous cohorts. The findings of our study may provide direct evidence of effectiveness and safety of camrelizumab in specific subsets of patients and thus aid in clinical decision-making and patient care. We present the following article in accordance with the STROBE reporting checklist (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-23-121/rc).[11]
Transl Lung Cancer Res. 2023;12(4):786-796. © 2023 AME Publishing Company
