Versamune HPV plus pembrolizumab demonstrated a 39.3-month median overall survival in HPV16-positive metastatic HNSCC patients with CPS ≥1, representing a substantial improvement over the 17.9-month historical benchmark with pembrolizumab alone. This combination therapy shows promise as a well-tolerated treatment option that may significantly extend survival in this rapidly growing cancer population.
Study Design & Population
- Single-arm phase 2 trial (VERSATILE-002) with 53 patients enrolled
- Patient population: HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma with CPS ≥1
- Treatment regimen: Subcutaneous Versamune HPV plus IV pembrolizumab for first 4 cycles, fifth Versamune dose at cycle 12
- Follow-up: Median 18.4 months (range 0.2-42.7 months)
Key Findings
- Primary endpoint: Median OS of 39.3 months (95% CI, 23.9-NE) in CPS ≥1 population
- Response rates: Overall response rate of 35.8% in CPS ≥1 patients, 47.6% in CPS ≥20 subgroup
- Disease control: 77.4% disease control rate with median duration of response 21.8 months
- Progression-free survival: 30.0 months (95% CI, 23.9-NE)
- Safety profile: No treatment discontinuations due to adverse events, 16.1% grade 3 TRAEs
Clinical Implications
- Treatment paradigm: Results support combination as potentially superior first-line option versus pembrolizumab monotherapy
- Patient selection: Benefit observed across CPS subgroups, suggesting broad applicability in HPV16-positive population
- Tolerability advantage: Excellent safety profile may allow treatment completion in more patients
Limitations
- Single-arm design limits direct comparison with standard care
- Historical control comparison rather than randomized concurrent control
- Limited follow-up for long-term safety assessment in some patients
