Patients with metastatic squamous non-small cell lung cancer (NSCLC) whose disease progressed following PD-(L)1 inhibitor therapy experienced a median overall survival of 18.5 months with the investigational anti-CTLA-4 antibody gotistobart compared with 10.0 months for patients receiving docetaxel, according to updated findings from Stage 1 of the Phase 3 PRESERVE-003 trial.
These results were presented today at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) in Seoul, Republic of Korea.
The updated analysis demonstrated a 43% reduction in the risk of death (HR=0.572) and confirmed a safety profile consistent with previous reports, with no new safety signals observed. Investigators also found that higher exposure to gotistobart was associated with improved overall survival, supporting the selected dosing regimen.
Gotistobart is an investigational anti-CTLA-4 monoclonal antibody designed to selectively deplete regulatory T cells within the tumor microenvironment. In pharmacokinetic analyses, the drug achieved substantially higher steady-state exposure than ipilimumab, while exposure-response analyses demonstrated a significant association between higher exposure and improved survival.
The updated survival findings reinforce the potential of gotistobart to provide a meaningful new treatment option for patients with metastatic squamous NSCLC whose disease has progressed following PD-(L)1 therapy."
Rama Balaraman, M.D., Ocala Oncology Center, Ocala, Fla., presenting author of the study
The results support continued evaluation of gotistobart in the pivotal portion of the ongoing PRESERVE-003 Phase 3 clinical trial.
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