Gotistobart vs Docetaxel in Metastatic Squamous NSCLC After PD-(L)1 Progression: Updated Overall Survival From Stage 1 of PRESERVE-003

Yi-Long Wu, MD, PhD, of the Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, presents updated overall survival (OS) results from nonpivotal Stage 1 of the phase 3 PRESERVE-003 trial in metastatic squamous non–small cell lung cancer (NSCLC) that progressed after chemotherapy and PD-1 or PD-L1 inhibitor therapy. Dr Wu explains that docetaxel offers limited benefit in this setting and that gotistobart is an anti–CTLA-4 antibody designed to spare CTLA-4 from breakdown and to clear regulatory T cells inside the tumor with little immune activation elsewhere. After a median follow-up of 25.4 months, median OS was 18.5 months with gotistobart vs 10 months with docetaxel (hazard ratio, 0.56), which Dr Wu describes as a clinically meaningful benefit. Grade 3 or higher treatment-related adverse events occurred in 44.4% vs 48.8% of patients, with no new safety signals and no treatment-related deaths. Dr Wu adds that pharmacology modeling supports the loading-dose regimen.