Multinational phase 3 trial of gotistobart versus docetaxel for metastatic squamous non-small cell lung cancer

Gotistobart is a novel pH-sensitive anti-CTLA-4 antibody. The multinational phase 3 PRESERVE-003 trial evaluated gotistobart in patients with metastatic squamous non-small cell lung cancer (sqNSCLC) without actionable genomic alterations who progressed on PD-(L)1 inhibitor and platinum-based chemotherapy – a population with a poor prognosis. Patients were randomized 1:1 to gotistobart (n=45) or docetaxel (n=42) every three weeks. Primary outcome was overall survival. After a median follow-up of 14.5 months, median overall survival was not reached with gotistobart versus 10.0 months with docetaxel (HR 0.46; p=0.0102), whereas there was no statistical significant difference for progression-free survival. Safety was manageable, with grade ≥ 3 treatment-related adverse events in 42% of the gotistobart group and 49% of the docetaxel group. The authors conclude that these results suggest that gotistobart monotherapy can provied clinically meaningful benefit for patients with metastatich sqNSCLC resistant to PD-(L)1 inhibitor and chemotherapy.