At ESMO 2025, N. Gopalakrishna Iyer presented the IHN01 trial in Proffered Paper Session 1 — Head & neck cancer, detailing a double-blind, placebo-controlled study across 26 centers in 12 countries
Background
Adjuvant cisplatin-based chemoradiotherapy (CRT) improves outcomes in high-risk head and neck squamous cell carcinoma (HNSCC), yet recurrences remain common and evidence for further intensification is limited. EGFR-targeting antibodies such as nimotuzumab may enhance radiosensitization while maintaining a favorable safety profile. IHN01 tested whether adding nimotuzumab to adjuvant CRT improves efficacy after curative-intent surgery for stage III/IV HNSCC.
Methods
IHN01 was a double-blind, randomized, placebo-controlled, phase III randomized multicenter trial across 26 centers in 12 countries. Only sites with high surgical standards and passing EqualEstro radiotherapy QA were included. Postoperative CRT comprised radiotherapy plus either cisplatin 100 mg/m² every 3 weeks ×3 or 30 mg/m² weekly ×7. Patients were randomized to weekly nimotuzumab 200 mg or placebo for 8 weeks. Co-primary endpoints: disease-free survival (DFS), overall survival (OS), and safety.
Results
- Between November 2009 and October 2018, 422 patients were enrolled; median follow-up was 61 months.
- DFS: Failure in 44% (nimotuzumab) vs 45% (placebo); HR 0.94 (95% CI 0.70–1.25), not significant.
- OS: Deaths in 30% vs 35%, respectively; HR 0.84 (95% CI 0.60–1.18), not significant.
- Safety: Grade ≥3 adverse events in 59% overall; 27% considered study-drug related. Safety profiles were similar between arms.
- Cisplatin schedule: Weekly cisplatin was associated with fewer grade ≥3 AEs than 3-weekly dosing, without DFS or OS differences between schedules.
Conclusions
Adding nimotuzumab to adjuvant cisplatin-CRT did not significantly improve DFS or OS in resected high-risk HNSCC, although tolerability was acceptable and broadly comparable to placebo. Weekly cisplatin appears less toxic than the 3-weekly regimen without compromising efficacy. IHN01 underscores that rigorous, investigator-initiated multicenter trials—leveraging independent QA—can efficiently test escalation strategies beyond cooperative groups and help refine standard adjuvant care.
You can read the full abstract here.