BioNTech SE and OncoC4 Inc. reported that gotistobart extended median overall survival to 18.5 months from 10 months with docetaxel in stage 1 of the global PRESERVE-003 Phase 3 trial in metastatic squamous non-small cell lung cancer. The analysis included 87 randomized patients in second-line or later treatment at a July 17 cutoff, with median follow-up of 25.4 months. Gotistobart produced a hazard ratio of 0.56 and a nominal p-value of 0.0295. Severe treatment-related adverse events occurred in 44.4% of gotistobart recipients, while reported docetaxel rates differed between analyses. The pivotal stage 2 segment continues enrolling at more than 160 sites worldwide, with a first interim analysis anticipated toward year-end.