Call for Abstracts
The structured abstracts should be written according to the rules of the Chicago congress: Up to ten authors can be listed. Please give only the first letters of prenames with a dot.
The institutions shall be listed in the order of the authors without links to the authors. Please give city and country of the institutions.
Please indicate the preferred type of presentation (oral or poster).
The text of the structured abstract (Background, Methods, Results, Conclusions) shall not exceed 2500 letters including blanks.
- It is acceptable to include a table as part of the abstract.
Please format the abstract as shown in the example below, please use Arial 10.
- All accepted abstracts will be published in the digital "Book of Abstracts" which can be downloaded after the congress here. Abstracts will not be edited by the Congress Secretariat prior to publication.
Phase I/II study of the tumor-targeting human L19-IL2 monoclonal antibody-cytokine fusion protein in combination with DTIC in metastatic melanoma patients. C. Garbe, A. Romanini, G. Spitaleri, L. Giovannoni, L. Zardi, D. Neri, A. Shaw, H. D. Menssen, F. deBraud, T. K. Eigentler; University of Tuebingen, Tuebingen, Germany; Santa Chiara University Hospital, Pisa, Italy; European Institute of Oncology, Milan, Italy; Philogen SPA, Siena, Italy; Istituto Giannina Gaslini, Genoa, Italy; Swiss Federal Institute of Technology, Zurich, Switzerland; Bayer HealthCare Pharmaceuticals, Montville, NJ
Background: L19-IL2 is a tumor targeted immunocytokine constituted by a single chain Fragment variable (scFv) format directed against the ED-B domain of fibronectin and the human cytokine interleukin-2 (IL2). The recommended dose (RD) for monotherapy of advanced solid cancer patients was established to be 22.5 Mio IU IL2 equivalent on day 1, 3, and 5 of a 21-day cycle. Here we report clinical results of the dose escalation part of a phase I/II study assessing L19-IL2 in combination with DTIC chemotherapy in metastatic melanoma patients.
Methods: L19-IL2 was administered as an i.v. infusion at doses of 10 (n=3), 15 (n=3) and 22.5 MioIU IL2 equivalent dose (n=4) on days 1, 3 and 5 every 21 days in combination with DTIC 1000 mg/m2 on Day 1 for up to 6 treatment cycles. Serum samples for PK evaluation and induction of human antifusion antibodies to L19 (HAFA) were collected. Flow cytometry (T and NK/B cell panels) was performed. Data on safety and activity were evaluated using CTC v3.0 and RECIST criteria, respectively.
Results: All 10 patients had progressive metastatic melanoma and the majority had already received prior systemic therapy. Median age at start of treatment was 62 years (52-74). There were no treatment related deaths and the treatment was well tolerated, details of CTC evaluation will be presented. The dose of 22.5 Mio IU day 1, 3, and 5 in combination with 1000 mg DTIC/m2 on day 1, repeated on day 22 was defined as the RD for up to 6 treatment cycles. 10 patients were evaluable for response. We observed 1 partial remission at the 15 Mio IL2 dose level after 4 treatment cycles. Immunophenotyping analysis showed transient stimulation of NK cells, T4 cells, and CTLs. Pharmacokinetic data will be presented.
Conclusions: L19-IL2 at a dose of 22.5 Mio IU IL2 equivalent on days 1, 3, and 5 of a 3-weekly schedule can be safely combined with standard DTIC in metastatic melanoma patients. Toxicity was manageable and reversible. Preliminary evaluation suggests clinical activity of the L19IL2/DTIC regimen in metastatic melanoma patients.