Until Dec. 31st 2021, the median follow-up was 5.6 months. ORR was 57.6% in sintilimab arms vs. 42.9% in pembrolizumab arms, and the confirmed ORR was 45.5% (15/33) vs. 28.6% (10/35), separately. The disease control rate was 87.9% vs. 91.4% in sintilimab and pembrolizumab arms, respectively. The primary endpoint was reached, with 15 confirmed PRs achieved in sintilimab arms. Survival data was still immature. Treatment-related adverse events were comparable between sintilimab and pembrolizumab arms. This head-to-head study of PD-1 inhibitors suggested comparable tumor response and similar safety profile between sintilimab and pembrolizumab.

This is a prospective, multi-center, phase II study (NCT04106180). Eligible patients (pts) were advanced EGFR/ALK negative NSCLC pts who had failed first-line standard chemotherapy….Partial response occurred in 7 and stable disease in 5 pts, the confirmed ORR was 35%. Median PFS was 6.9 (95% CI, 2.76-NA) months with 12 events and 1-year OS rate was 75.0% (95% CI, 58.2%-96.6%)....Triple combination of Sintilimab, SBRT and GM-CSF is safe and shows promising efficacy as a novel second-line treatment for advanced EGFR/ALK negative NSCLC.