Role of immunotherapy in ca vulva. Give detailed overview from latest medical journal and evidence. Make flowcharts and tables.
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vulvar cancer immunotherapy PD-1 PD-L1
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immunotherapy vulvar carcinoma 2024 2025 clinical trials checkpoint inhibitors pembrolizumab
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immunotherapy vulvar cancer clinical trials pembrolizumab nivolumab outcomes biomarkers
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vulvar squamous cell carcinoma immunotherapy checkpoint inhibitor
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Here is a summary of what this overview covers:
What This Overview Covers
This is a comprehensive, evidence-based synthesis drawn from 7 key publications (2022-2025), including the most up-to-date systematic review + meta-analysis (Maiorano et al., Cancers 2025, N=181 patients across 6 trials) and multiple Phase II trials reported as recently as August 2025.
Key Takeaways:
Efficacy: ICIs show modest but real activity in VSCC - pooled ORR 21% (monotherapy 11%, combination 46%). The best results come from combination approaches, particularly pembro + CRT (ORR 75% in locally advanced disease) and pembro + vorinostat (mOS 17.5 months - best survival data in the field).
Biomarkers: This is the critical gap. PD-L1 is required for FDA-approved second-line pembrolizumab use, but meta-analysis shows PD-L1 does NOT reliably predict response. MSI-H/dMMR and TMB-High remain the most actionable biomarkers. HPV status appears to influence TME immunogenicity favorably but is not yet a selection criterion.
Safety: Manageable but not trivial - 23% grade ≥3 AEs, 3% treatment-related death in pooled data.
Regulatory status: FDA-approved for pembrolizumab (biomarker-driven), NCCN-listed for nivolumab; EMA has NOT yet approved ICIs for VSCC.
Most urgent need: Biomarker-stratified, randomized controlled trials - which do not yet exist for VSCC-specific ICI use.
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