(SEOUL, Republic of Korea —Tuesday, September 15 th , 9:45 a.m. Korea Standard Time) — 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,” said 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.
About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org for more information.
About the WCLC:
The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc.iaslc.org/.