Gotistobart nearly doubles survival in squamous NSCLC

BioNTech and OncoC4 presented the first median overall-survival data from non-pivotal stage 1 of the Phase 3 PRESERVE-003 trial at WCLC on September 14: gotistobart (BNT316/ONC-392) posted 18.5 months median OS versus 10.0 months for docetaxel (HR 0.56; nominal p=0.0295). The July 17, 2026 cut-off covered 87 previously treated squamous NSCLC patients (45 gotistobart, 42 docetaxel) after a median 25.4 months of follow-up; grade 3 or higher treatment-related adverse events were 44.4 percent versus 48.8 percent. Pivotal stage 2 is ongoing at more than 160 sites.