Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial - PubMed
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- #immunotherapy
- #clinical trial
- #lung cancer
- PRESERVE-003 is a phase 3 trial evaluating gotistobart, a pH-sensitive anti-CTLA-4 antibody, vs. docetaxel in metastatic squamous non-small cell lung cancer (sqNSCLC) patients who progressed on prior PD-1/PD-L1 inhibitor and platinum chemotherapy.
- Stage 1 results showed median overall survival was not reached with gotistobart vs. 10.0 months with docetaxel (hazard ratio 0.46, nominal P = 0.0102), suggesting clinically meaningful benefit.
- Safety was manageable, with grade ≥3 treatment-related adverse events in 42% of gotistobart patients and 49% of docetaxel patients.