SSGJ-707 (PF-08634404) PD-1×VEGF Bispecific Delivers 67.6% ORR and 12.4-mo mPFS in 1L PD-L1+ NSCLC

SSGJ-707 is a fully human IgG4 bispecific antibody that simultaneously binds PD-1 and VEGF, aiming to pair checkpoint blockade with anti-angiogenic activity in a single agent. In the Phase 2 NCT06361927 dose-finding study of treatment-naive advanced NSCLC without actionable genomic alterations and with PD-L1 TPS ≥1%, the FDA-aligned 10 mg/kg Q3W cohort (n=34; median follow-up 15.2 months) showed confirmed ORR 67.6% (95% CI, 49.5-82.6%), median DOR NR (95% CI, 10.9-NR), median PFS 12.4 months (95% CI, 8.2-NR), and median OS NR (95% CI, 14.8-NR); this sits above typical pembrolizumab monotherapy benchmarks in PD-L1–selected 1L disease (e.g., KEYNOTE-042 mOS 16.7 months in TPS ≥1% and KEYNOTE-024 mPFS 10.3 months in TPS ≥50%—noting cross-trial differences and the single-arm design). Across all treated patients (n=83), TRAEs occurred in 92.8% with grade ≥3 TRAEs in 42.2% (most common grade ≥3: pneumonia 8.4%, hypertension 7.2%, hemoptysis 6.0%); VEGF-related AEs occurred in 62.7% (grade ≥3 18.1%) and immune-mediated AEs in 37.3% (grade ≥3 8.4%), while in the 10 mg/kg group permanent discontinuation due to TRAEs was 2.9% with no grade 5 TRAEs; ctDNA clearance at C3D1 associated with longer PFS (NR vs 7.6 months if still detectable).