Neoadjuvant L19IL2/L19TNF- Pivotal Study

Summary

Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients.

Timeline

Start

2016-07-01

Primary completion

2024-10

Completion

2028-12

Outcome

Met primary endpoint

paper the neoadjuvant group (n = 122) had a significantly longer RFS than the upfront surgery group (n = 124) PMID 40633690 ↗

paper hazard ratio (HR) 0.59, 95% confidence interval (CI 0.41-0.86), P = 0.005, log-rank test PMID 40633690 ↗

Publications

• Kahler KC, Hassel JC, Ziemer M, Rutkowski P, Meier F, Flatz L, Gaudy-Marqueste C, Zimmer L, Santinami M, Russano F, von Wasielewski I, Eigentler TK, Maio M, Zalaudek I, Haferkamp S, Quaglino P, Welzel J, Rocken C, Enk A, Simon JC, Switaj T, Garzarolli M, Amaral T, Malissen N, Livingstone E, Elia G, Covelli A, Lorizzo K, Neri D, Mulatto S, Parca A, Pizzichi B, Ascierto PA, Garbe C, Robert C, Schadendorf D, Hauschild A. Neoadjuvant intralesional targeted immunocytokines (daromun) in stage III melanoma. Ann Oncol. 2025 Oct;36(10):1166-1177. doi: 10.1016/j.annonc.2025.06.014. Epub 2025 Jul 7.
• Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darleukin	Protein / enzyme biologic	1.3e+07 iu	Other
Subject	Onfekafusp alfa	Protein / enzyme biologic	400 ug	Other

Indications