A phase II study of the L19IL2 immunocytokine in combination with dacarbazine in advanced metastatic melanoma patients: Cancer Immunology, Immunotherapy

B. Weide, T. Eigentler, C. Catania, P.A. Ascierto, S. Cascinu, J.C. Becker, A. Hauschild, A. Romanini, R. Danielli, R. Dummer, U. Trefzer, G. Elia, D. Neri, C. Garbe

Research output: Contribution to journalArticlepeer-review


Engineered cytokine products represent promising agents for the treatment of immunogenic tumors, such as malignant melanoma, in addition to immune checkpoint inhibitors. Here we describe the results of a controlled, randomized phase II clinical trial, aimed at assessing the therapeutic potential of L19IL2, a fully human fusion protein consisting of the L19 antibody specific to the alternatively spliced extra-domain B of fibronectin, fused to human interleukin-2 in advanced metastatic melanoma. In one arm, patients received dacarbazine (DTIC; 1000 mg/m2 of body surface on day 1 of 21-day cycles) as single agent, while in two other arms L19IL2 (22.5 million international units of IL2 equivalents) was added, based on two different schedules of administration. In total, 69 patients with stage IV melanoma were enrolled (24 in the dacarbazine arm, 23 and 22 in the other combination arms, respectively) and 67 received treatment. Analyses of efficacy results show a statistically significant benefit in terms of overall response rate and median progression-free survival for patients receiving L19IL2 in combination with DTIC, compared to DTIC as single agent. In light of these results, further clinical investigations with L19IL2 (alone or in combination with other agents) are warranted. © 2019, Springer-Verlag GmbH Germany, part of Springer Nature.
Original languageEnglish
Pages (from-to)1547-1559
Number of pages13
JournalCancer Immunol. Immunother.
Issue number9
Publication statusPublished - 2019


  • Dacarbazine
  • Immunocytokine
  • L19IL2
  • Phase II study
  • Stage IV melanoma
  • alanine aminotransferase
  • aspartate aminotransferase
  • dacarbazine
  • darleukin
  • gamma glutamyltransferase
  • l 19il 2
  • antineoplastic agent
  • fusion protein
  • L19-IL2 immunocytokine
  • acute heart infarction
  • add on therapy
  • adult
  • advanced cancer
  • aged
  • alanine aminotransferase blood level
  • anorexia
  • arthralgia
  • Article
  • aspartate aminotransferase blood level
  • cancer combination chemotherapy
  • cancer immunotherapy
  • cancer patient
  • cancer prognosis
  • cancer staging
  • cancer survival
  • cerebrovascular accident
  • chill
  • comparative effectiveness
  • controlled study
  • diarrhea
  • drug efficacy
  • drug fatality
  • drug safety
  • drug tolerability
  • drug withdrawal
  • efficacy parameters
  • fatigue
  • female
  • fever
  • gamma glutamyl transferase blood level
  • human
  • induction chemotherapy
  • maintenance chemotherapy
  • major clinical study
  • male
  • median survival time
  • metastatic melanoma
  • monotherapy
  • multicenter study
  • multiple cycle treatment
  • nausea
  • neutropenia
  • open study
  • overall survival
  • peripheral edema
  • phase 2 clinical trial
  • priority journal
  • progression free survival
  • prospective study
  • randomized controlled trial
  • rash
  • response evaluation criteria in solid tumors
  • side effect
  • survival rate
  • thrombocytopenia
  • treatment response
  • vomiting
  • clinical trial
  • melanoma
  • middle aged
  • mortality
  • skin tumor
  • survival analysis
  • very elderly
  • young adult
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols
  • Female
  • Humans
  • Male
  • Melanoma
  • Middle Aged
  • Neoplasm Staging
  • Recombinant Fusion Proteins
  • Skin Neoplasms
  • Survival Analysis
  • Young Adult


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