{"entity":{"id":"daromun","kind":"drug","name":"Daromun","aka":["L19IL2 + L19TNF","Onfekafusp alfa and bifikafusp alfa","Darleukin + Fibromun"],"tldr":"Daromun is a pair of antibody-linked immune messengers injected straight into melanoma deposits before surgery. In a phase 3 trial it lowered the chance of the melanoma coming back after the operation compared with surgery alone.","summary":"Daromun is Philogen's combination of two immunocytokines, L19IL2 (onfekafusp alfa) and L19TNF (bifikafusp alfa). Both use the human antibody L19, which targets the extra-domain B of fibronectin found in new tumour blood vessels, to concentrate interleukin-2 and tumour necrosis factor in the tumour after direct injection into skin and lymph node deposits. Local delivery gives the immune stimulation of these cytokines without the toxicity of giving them systemically.\n\nIn the randomised phase 3 PIVOTAL trial in resectable stage III melanoma with injectable deposits, four weekly intralesional treatments before surgery improved relapse-free survival compared with surgery alone. Philogen has filed for European approval on this result. The stage III melanoma page names it beside talimogene laherparepvec as an intralesional option before excision.","status":"phase-3","asOf":"2026-09-17","links":[],"tags":["subtype-drugs-wave"],"related":["talimogene-laherparepvec"],"cancers":["stage-iii-melanoma"],"sections":[],"technologies":["immunocytokines"],"targets":[],"drugs":[],"companies":["philogen-s-p-a"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"modality":"Intralesional immunocytokine combination","mechanism":"Two antibody-cytokine fusion proteins that use the L19 antibody, which binds the EDB domain of fibronectin in tumour blood vessels, to hold interleukin-2 and tumour necrosis factor inside the injected melanoma deposit, where they recruit and activate T cells and destroy tumour vasculature.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/daromun/","neighbours":{"drug":[{"id":"talimogene-laherparepvec","kind":"drug","name":"Talimogene laherparepvec","route":"/drugs/talimogene-laherparepvec/"}],"cancer":[{"id":"stage-iii-melanoma","kind":"cancer","name":"Stage III melanoma (after surgery)","route":"/cancers/stage-iii-melanoma/"}],"technology":[{"id":"immunocytokines","kind":"technology","name":"Immunocytokines (antibody-cytokine fusions)","route":"/technologies/immunocytokines/"}],"company":[{"id":"philogen-s-p-a","kind":"company","name":"Philogen S.p.A.","route":"/companies/philogen-s-p-a/"}]}}