SigVie-002 (Be6A Lung-01)

June 22, 2026: Pfizer Inc. (NYSE: PFE) reported topline results from the Phase 3 SigVie-002 trial (previously Be6A Lung-01; NCT06012435) of sigvotatug vedotin, an investigational integrin beta-6 (IB6)–directed antibody-drug conjugate, versus docetaxel in adults with previously treated locally advanced/unresectable or metastatic non-squamous NSCLC (≥1 prior line). In the overall population (703 participants), the study did not show a statistically significant improvement in the primary endpoint of overall survival versus docetaxel. Safety was described as manageable and consistent with prior studies. In a subgroup with only one prior line of systemic therapy (about two-thirds of patients), Pfizer reported a stronger trend favoring sigvotatug vedotin for OS and progression-free survival; exploratory analyses showed no clear relationship between IB6 expression and response. Pfizer said detailed results will be submitted for presentation at a future medical congress.

Ongoing/next catalysts mentioned: a Phase 3 trial of sigvotatug vedotin + pembrolizumab in first-line NSCLC with PD-L1 TPS ≥50%, and early combination exploration including with PF-08634404 (PD-1 x VEGF bispecific) in early-stage lung cancers and other IB6-expressing tumors.