A phase II study of intratumoral application of L19IL2/L19TNF in melanoma patients in clinical stage III or stage IV M1a with presence of injectable cutaneous and/or subcutaneous lesions.

TPS9103^ Background: Preclinical studies in three different murine models of subcutaneous tumors have shown that a single intratumoral injection of a combination of two immunocytokines, L19-IL2 and L19-TNF is more effective than each immunocytokine in monotherapy and is curative in 100% of animals. Furthermore, in the clinical setting intralesional delivery of L19-IL2 elicited objective responses in >50% of Stage III melanoma patients, with a possible benefit in terms of distant metastases-free survival rates for these patients and evidence of systemic immune responses in most evaluable patients. L19-IL2 and L19-TNF are recombinant fusion proteins, consisting of the single-chain monoclonal antibody (L19) directed against extradomain B of fibronectin, a well-characterized marker of angiogenesis, fused to IL2 or TNF cytokines, respectively. Methods: A Phase II, uncontrolled, multicenter, prospective study is ongoing at two centers in Italy (EudraCT Number: 2012-001991-13). Twenty patients with unresectable ...