Pembrolizumab (PD-1) + nab-paclitaxel (albumin-bound taxane) + platinum hits 64% ORR and 12.7-mo PFS in 1L R/M HNSCC

Pembrolizumab is an anti–PD-1 antibody combined here with nab-paclitaxel (a solvent-free, albumin-bound paclitaxel) plus cisplatin or carboplatin as first-line therapy in a single-arm Phase 2 trial in treatment-naïve recurrent/metastatic HNSCC (NCT04857164; n=148; enrollment Apr 2021–Feb 2025; median follow-up 23.0 months). ORR was 64.2% (DCR 93.2%), with median PFS 12.7 months and median OS 21.8 months—numerically longer than the KEYNOTE-048 pembrolizumab + platinum/5-FU benchmark (median PFS ~5.0 months; median OS ~13.0 months overall; OS ~13.6 months in PD-L1 CPS≥1 and ~14.7 months in CPS≥20), and also longer than historical EXTREME cetuximab + platinum/5-FU (mOS ~10.1 months; mPFS ~5.6 months). Immune-related AEs highlighted hypothyroidism in 27% (mostly grade 1–2; 1 grade 3); the abstract does not report overall grade ≥3 toxicity rates, chemo-related AEs, or discontinuations, limiting cross-regimen tolerability comparisons; a 7-variable random-forest model showed time-dependent AUCs up to 0.753–0.919 (test) for PFS and 0.784–0.908 (test) for OS, with “high-risk” scores associated with nutritional depletion/inflammation phenotypes.