Phase 3 Stage 1 randomized controlled trial of gotistobart vs. docetaxel in patients with metastatic squamous cell lung cancer who have progressed on PD-(L)1 inhibitors

In this OncLive Rapid Readout, Mark Socinski, MD, reviews Stage 1 findings from the phase 3 PRESERVE-003 trial evaluating gotistobart, an investigational pH-sensitive anti-CTLA-4 monoclonal antibody, vs docetaxel in patients with metastatic squamous non-small cell lung cancer whose disease progressed after PD-(L)1 inhibitor and platinum-based chemotherapy. The analysis showed clinically meaningful antitumor activity with gotistobart, including a confirmed overall response rate of 20.0% vs 4.8% with docetaxel and a median duration of response of 11.0 months vs 3.8 months. At a median follow-up of 14.5 months, median overall survival was not reached with gotistobart compared with 10 months for docetaxel, corresponding to a 54% reduction in the risk of death. Socinski also discusses progression-free survival trends, safety outcomes, and the potential role of gotistobart as a chemotherapy-free option for treatment-resistant squamous NSCLC as pivotal Stage 2 enrollment nears completion globally.