Merck reports Phase 2 results of coformulation for lung cancer

Merck announced full results from the non-registrational Phase 2 KeyVibe-002 trial evaluating vibostolimab/pembrolizumab, an investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab – Keytruda -, Merck’s anti-PD-1 therapy, with or without docetaxel for the treatment of patients with metastatic non-small cell lung cancer – NSCLC – with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy. Data showed that vibostolimab/pembrolizumab plus docetaxel extended median progression-free survival – PFS – by 2.4 months vs. docetaxel alone, though the results did not reach statistical significance. Vibostolimab/pembrolizumab alone did not show an improvement in median PFS compared to docetaxel alone. Vibostolimab/pembrolizumab plus docetaxel improved Overall Survival vs. docetaxel alone, though these results did not reach statistical significance. Vibostolimab/pembrolizumab alone did not show an improvement in OS vs. docetaxel alone. The Overall Response Rate for patients receiving vibostolimab/pembrolizumab plus docetaxel was 29.9%, 6.0% for vibostolimab/pembrolizumab alone and 15.3% for docetaxel. The safety profile of vibostolimab/pembrolizumab was consistent with that observed for vibostolimab and pembrolizumab in previously reported studies, with no new safety signals observed. In the vibostolimab/pembrolizumab only arm of the study, there was a lower incidence of treatment-related adverse events – TRAEs – of any grade vs. the docetaxel only arm and 96.5% of patients in the vibostolimab/pembrolizumab plus docetaxel arm had TRAEs.