Florian Lordick, Professor of Medicine at University of Leipzig, shared a post on LinkedIn:
“First results from the ADRISK trial (NCT03480672)
Research from the Leipzig University, presented at the oral plenary session: Pembrolizumab added to adjuvant radiochemotherapy in locally advanced HNSCC
Presented at ESMO2025 by Prof. Andreas Dietz (Leipzig, Germany).
Patients with locally advanced head and neck squamous cell carcinoma (HNSCC) often require adjuvant cisplatin-based radiochemotherapy (aRCH) after curative surgery due to intermediate or high-risk pathological features. The phase IIB ADRISK trial investigated whether adding the PD-1 inhibitor pembrolizumab to standard aRCH could improve outcomes.
Study design:
- Randomized 1:1 (n=211, 204 treated)
- Standard aRCH vs. aRCH + pembrolizumab (200 mg q3w for up to 12 months)
- Stratified by p16 status and tumor localization
- Primary endpoint: Event-free survival (EFS)
Key findings (median follow-up: 30 months):
- Numerical improvement in EFS with pembrolizumab (HR 0.81; 95% CI 0.52–1.46; p=0.423)
- No significant difference in OS (HR 0.85; 95% CI 0.46–1.57; p=0.591)
Subgroup trends:
- HPV-unrelated, CPS ≥10 tumors (≈39% of cohort) showed most pronounced benefit (HR 0.80; 95% CI 0.43–1.48)
- No new safety signals observed
Conclusion:
While ADRISK did not meet its primary endpoint due to fewer than expected events (notably in p16+ cases), the data suggest potential benefit for patients with HPV-unrelated, PD-L1–positive HNSCC — warranting further investigation of adjuvant immunotherapy in this setting.
Congratulations to Prof. Andreas Dietz and the entire ADRISK study group for advancing our understanding of adjuvant immunotherapy in head and neck cancer!”
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