Abstract 695P
Background
Programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitors have become an important treatment in both monotherapy and combination therapy for advanced non-small cell lung cancer (NSCLC). Envafolimab, a humanized subcutaneous PD-L1 monoclonal antibody, has been approved for defective mismatch repair (dMMR)/microsatellite instability high (MSI-H) tumors. We conducted an open-label, non-randomised, phase II study to evaluate the efficacy and safety of envafolimab in patients with previously treated, locally advanced or metastatic NSCLC (ClinicalTrials.gov: NCT 05529355).
Methods
Patients received subcutaneous envafolimab 150mg every week, combined with chemotherapy or anti-vascular endothelial growth factor receptor treatment. The primary end point was objective response rate (ORR), and the second end points included disease control rate (DCR), progression-free survival (PFS), and safety.
Results
Of the 20 patients enrolled in this study, a 15% ORR and 70% DCR were observed. Median PFS was five months (95% CI 3.643-6.357). Median OS was 38 months (95% CI 26.936–49.064). In the multivariate Cox regression model, the presence of actionable genomic alterations were significant risk factors for poor PFS (P=0.037, HR=5.702). The most common adverse event was immune-related endocrinopathies (35%, 7/20). Of 18 patients received programmed death-1 (PD-1) inhibitors on first-line treatment, 1/3 (n=6) patients switched to envafolimab for adverse events of first-line immune therapy and no new safety signals were observed. No grade 4 adverse events or treatment-related death occurred.
Conclusions
Envafolimab is efficient, safe and convenient as second-line treatment for locally advanced or metastatic NSCLC, especially for those with unbearable PD-1 related toxicity.
Clinical trial identification
NCT 05529355.
Editorial acknowledgement
Legal entity responsible for the study
China International Medical Foundation.
Funding
China International Medical Foundation [No. Z2014-06-2201].
Disclosure
All authors have declared no conflicts of interest.