Gotistobart (BNT316/ONC-392)
Overview
A next-generation, pH-sensitive anti-CTLA-4 antibody designed to deplete regulatory T cells within tumors while sparing normal tissue, co-developed with OncoC4 since a March 2023 strategic collaboration ($200M upfront to OncoC4, costs and profits split on PD-(L)1 combination studies, BioNTech holding exclusive worldwide commercialization rights). It is BioNTech's fourth late-stage oncology asset alongside BNT327, trastuzumab pamirtecan, and elfetabart drozuntecan.
Pivotal, two-stage Phase 3 PRESERVE-003 trial (691 patients total) versus docetaxel in metastatic squamous NSCLC after progression on a PD-(L)1 inhibitor. Non-pivotal stage 1 at WCLC 2026 (September 14, 2026) reported the first median overall survival: 18.5 months for gotistobart versus 10.0 months for docetaxel (HR 0.56; nominal p=0.0295) in 87 patients after 25.4 months median follow-up, after ELCC 2026 had shown a 54% reduction in risk of death with median OS not yet reached. Pivotal stage 2 is ongoing at more than 160 sites globally. The FDA granted Orphan Drug Designation in squamous NSCLC in January 2026, on top of a 2022 Fast Track designation.