BioNTech SE and OncoC4, Inc. have announced new data from the initial, non-registrational dose-finding phase of the global, randomized Phase 3 PRESERVE-003 clinical trial (NCT05671510) for Gotistobart (BNT316/ONC-392). Gotistobart, a selective Treg-modulator targeting CTLA-4, is being evaluated in patients with metastatic squamous non-small cell lung cancer (sqNSCLC) whose disease progressed following prior anti-PD-$(L)$1 therapy and platinum-based chemotherapy. The candidate demonstrated a clinically relevant overall survival benefit compared to standard chemotherapy and exhibited a manageable safety profile. In the first part of the study, Gotistobart reduced the risk of death by more than half versus standard chemotherapy. Median overall survival for patients receiving Gotistobart was not reached after nearly 15 months of follow-up, whereas the chemotherapy group had a median overall survival of 10 months. These data were presented at the IASLC ASCO 2025 North America Conference on Lung Cancer.