Multinational phase 2 trial of simlukafusp alfa plus atezolizumab for recurrent and/or metastatic cervical squamous cell carcinoma

Simlukafusp alfa (FAP-IL2v) is an immune cytokine engineered to selectively promote immune responses in the tumor microenvironment. A multinational phase 2 trial evaluates FAP-IL2v plus atezolizumab for recurrent or metastatic (R/M) solid tumors. Results of the R/M cervical squamous cel carcinoma (SCC) cohort have been published. Objective response (primary endpoint) were seen 27% of patients (95% CI 16.0-41.0) including 32% (15.4-54.0) of PD-L1 positive patients and 21% (9.2-35.6) of PD-L1 negative patients. Median duration of response was 13.3 months (95% CI 7.6-NE) and median progression-free survival was 3.7 months (3.3-9.0). Adverse events leading to withdrawal of either agent occurred in 13% of patients. The authors conclude that the combination of AP-IL2v and atezolizumab is clinically active and has manageable safety in patients with R/M cervical SCC.