Investigational immunotherapy nearly doubles survival in squamous NSCLC

Clinical takeaway: For patients with metastatic squamous NSCLC whose disease progresses after PD-(L)1 inhibitor therapy, the investigational anti-CTLA-4 antibody gotistobart demonstrated substantially longer overall survival than docetaxel, supporting its potential as a future treatment option in this difficult-to-treat setting.

Treatment options remain limited for patients with metastatic squamous NSCLC after progression on immunotherapy. Docetaxel has long been a standard second-line therapy, but outcomes are generally poor, creating a need for more effective approaches.

Results from the phase 3 PRESERVE-003 trial were presented at the IASLC 2026 World Conference on Lung Cancer and had not undergone peer review at the time of reporting.

Updated findings from Stage 1 of PRESERVE-003 showed a median overall survival of 18.5 months with gotistobart versus 10.0 months with docetaxel. The investigational therapy reduced the risk of death by 43% compared with chemotherapy.

Gotistobart is a novel anti-CTLA-4 monoclonal antibody designed to selectively deplete regulatory T cells within the tumor microenvironment. Investigators reported that patients with higher drug exposure experienced better survival outcomes, providing additional support for the selected dosing strategy. Pharmacokinetic analyses also showed substantially greater steady-state exposure with gotistobart than has been reported with ipilimumab.

The updated analysis confirmed a safety profile consistent with earlier reports, with no new safety signals identified. The findings support continued evaluation of gotistobart in the ongoing pivotal portion of the PRESERVE-003 phase 3 program.

“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 presenting author Rama Balaraman, MD.

Source: Balaraman R, et al. (2026 Sep 15). 2026 World Conference on Lung Cancer. Investigational Immunotherapy Nearly Doubles Overall Survival Compared with Docetaxel in Advanced Squamous NSCLC