Neoadjuvant Intralesional Daromun (L19IL2/L19TNF) in Resectable Locally Advanced Melanoma: An Update on the Efficacy and Safety Results of the PIVOTAL Phase III Trial.
J Clin OncolAug 11, 2026 (epub)
Clinical ResearchOncology (Medical)
Axel Hauschild, Jessica Cecile Hassel, Mirjana Ziemer et al.
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In 30 seconds
The PIVOTAL Phase III trial evaluated the efficacy and safety of neoadjuvant intralesional daromun (L19IL2/L19TNF) in 256 patients with fully resectable stage III melanoma. The study found a significant improvement in recurrence-free survival (RFS) with a hazard ratio of 0.59 (P = .005) for daromun followed by surgery compared to up-front surgery, at a median follow-up of 36.8 months.
Key findings
- Daromun treatment resulted in a statistically significant improvement in RFS with a hazard ratio of 0.59.
- The trial included 256 patients, with 87% having recurrent disease.
- No new safety signals were identified during the updated analysis.
Why it matters
The findings suggest that neoadjuvant daromun may enhance outcomes for patients with resectable stage III melanoma, potentially influencing treatment strategies to improve recurrence rates.