Efficacy and safety of anti-PD-1/PD-L1 antibodies plus chemotherapy as first-line treatment for non-small cell lung cancer in China: a systematic review and meta-analysis

Introduction The available approved anti-cancer drugs for Chinese patients are relatively limited because of China's low participation rate in international clinical trials. Therefore, a focus on approved anti-PD-1/PD-L1 drugs in China is needed. This study aims to assess the heterogeneity of anti-PD-1/PD-L1 antibodies manufactured in China (domestic PD-1/PD-L1) and overseas (imported PD-1/PD-L1) when combined with chemotherapy as the first-line treatment of NSCLC. Methods A systematic search was performed using PubMed, EMBASE, and Cochrane Library of publications up to July 13, 2023. Meta-analysis was applied to compare the efficacy and safety profile between anti-PD-1/PD-L1 antibodies plus chemotherapy (PD-1/PD-L1+Chemo) and chemotherapy alone using STATA software. Pooled hazard ratios (HRs) for PFS and OS, odds ratios (ORs) for ORR and incidence rate of grade≥3 trAEs with 95% confidence intervals (CIs) were calculated in the domestic group and imported group by a random-effects model and the heterogeneity between the two estimates was assessed. Results Fourteen eligible clinical studies with a total of 3951 patients were involved in this analysis, including eight studies of domestic PD-1/PD-L1+Chemo and six studies of imported PD-1/PD-L1+Chemo. The study showed that there was no significant difference between domestic and imported PD-1/PD-L1+Chemo in OS (P=0.80), PFS (P=0.53), and incidence rate of grade≥3 trAEs (P=0.10). However, the ORR of imported PD-1/PD-L1+Chemo was significantly higher than domestic PD-1/PD-L1+Chemo (P=0.03). Conclusions Domestic anti-PD-1/PD-L1 antibodies plus chemotherapy showed comparable efficacy and safety to those combined with imported anti-PD-1/PD-L1 antibodies based on current evidence.