Key points are not available for this paper at this time.
Envafolimab has been used as the first subcutaneously injected PD-L1 inhibitor for the treatment of solid tumors. Therefore, this study aims to investigate the efficacy and safety of envafolimab in combination with recombinant human endostatin (Rh-endostatin) as a first-line treatment modality and chemotherapy in patients with driver-negative advanced NSCLC. This was a single-arm, single-center, prospective, phase II clinical study. Between April 2022 and August 2023, consecutive eligible patients with histologically or cytologically confirmed with untreated stage IV NSCLC (excluding driver mutations) were enrolled. Patients received 4-6 cycles of envafolimab and Rh-endostatin combined with platinum-based dual-agent chemotherapy, followed by maintenance therapy with envafolimab and Rh-endostatin until disease progression or intolerable toxicity. The primary endpoints were the objective response rate (ORR) and disease control rate (DCR), and secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and tolerability. As of December 1, 2023, the median follow-up was 11.8 months (95% CI, 9.4-12.6). 29 patients with advanced NSCLC were enrolled at Shandong Cancer Hospital, 14/29 were squamous cell carcinoma, and 15/29 were non-squamous non-small cell lung cancer. The ORR was 72.4% (95% CI, 54.3% - 85.3%), and the DCR was 93.1% (95% CI, 78.0%- 98.1%), showing statistically significant differences compared with data from previous results. Median PFS and OS were not reached yet. Safety was manageable with no ≥ grade 3 treatment-related adverse events (TRAEs) or immune-related adverse events (irAEs). Envafolimab in combination with Rh-endostatin and chemotherapy as a first-line treatment for lung cancer exhibits favorable therapeutic efficacy with a manageable safety profile, which might represent a promising treatment regimen and warrant further investigation.
Yuan et al. (Fri,) studied this question.