- Adjuvant ipilimumab maintained benefits across survival outcomes at 7 years of follow-up of the European Organisation for Research and Treatment of Cancer (EORTC) 18071 phase 3 trial in patients who underwent complete resection for high-risk, stage 3 cutaneous melanoma.
Why this matters
- Ipilimumab received initial approval on the basis of significantly extended recurrence-free survival (RFS; P=.0013).
- Long-term follow-up of the EORTC 18071 phase 3 trial in 951 patients who underwent complete resection for stage 3 cutaneous melanoma (excluding lymph node metastasis ≤1 mm/in-transit metastasis).
- Randomization: 475 patients received ipilimumab, 476 patients received placebo.
- Funding: Bristol-Myers Squibb.
- Median follow-up, 6.9 years.
- 7-year RFS with ipilimumab was 39.2% vs 30.9% with placebo.
- Median RFS with ipilimumab was 2.7 years vs 1.5 with placebo (HR, 0.75; P=.0004).
- 7-year distant metastasis-free survival (DMFS) with ipilimumab was 44.5% vs 36.9% with placebo.
- Median DMFS with ipilimumab was 5.0 years vs 2.4 years with placebo (HR, 0.76; P=.0018).
- 7-year OS with ipilimumab was 60.0% vs 51.3% with placebo.
- Median OS was not reached with ipilimumab vs 7.8 years with placebo (HR, 0.73; P=.0021).
- No significant factors predictive of outcomes were identified.