Top

Published in:

01-01-2019 | Focussed Research Review

The Italian Network for Tumor Bio-Immunotherapy (NIBIT) Foundation: ongoing and prospective activities in immuno-oncology

Authors: Anna Maria Di Giacomo, Alessia Covre, Gianluca Giacobini, Ramy Ibrahim, Jaclyn Lyman, Pier Giorgio Natali, Michele Maio

Published in: Cancer Immunology, Immunotherapy | Issue 1/2019

Abstract

The ongoing revolution in cancer immunotherapy stems from the knowledge that distinct immune-checkpoints regulate the physiological crosstalk between and among immune cells by delivering inhibitory or activating signals. These notions, and the availability of mAb directed to diverse immune-checkpoint molecules, have led to a significant clinical improvement in cancer treatment. In this scenario, further achievements are undoubtedly to be expected from the contribution of novel, proof-of-principle clinical trials designed to explore the therapeutic efficacy of new immunotherapy-based combinations and treatment sequences. Along these lines, the clinical translation of pre-clinical evidence generated by non-profit research entities is likely to provide a significant contribution to gaining new insights that will further boost the field of cancer immunotherapy. To pursue this goal, and to provide comprehensive educational programs in immune-oncology (I-O), several national and global networks have been revitalized or newly established in recent years. This rapidly evolving scenario led the Board of Directors of the Italian Network of Tumor Bio-Immunotherapy (NIBIT) to establish the NIBIT Foundation. This Focused Research Review summarizes the main ongoing and prospective I-O activities of the NIBIT Foundation.

Maio M, Fonsatti E (2014) The Italian Network for Tumor Biotherapy (NIBIT): past, present and future goals. Rev Health Care 5(1):3–6. https://doi.org/10.7175/rhc.v5i1.896 CrossRef

Maio M, Lofiego MF, Fazio C, Cannito S, Chiarucci C, Giacobini G, Valente M, Tunici P, Covre A, Russo V (2018) Fifteenth Meeting of the Network Italiano per la Bioterapia dei Tumori (NIBIT) on Cancer Bio-Immunotherapy, Siena, Italy, October 5–7, 2017. Cancer Immunol Immunother. https://doi.org/10.1007/s00262-018-2222-0 CrossRefPubMed

Korn EL, Liu PY, Lee SJ, Chapman JA, Niedzwiecki D, Suman VJ, Moon J, Sondak VK, Atkins MB, Eisenhauer EA, Parulekar W, Markovic SN, Saxman S, Kirkwood JM (2008) Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol 1 26(4):527–534. https://doi.org/10.1200/JCO.2007.12.7837 CrossRefPubMed

Margolin K, Ernstoff MS, Hamid O, Lawrence D, McDermott D, Puzanov I, Wolchok JD, Clark JI, Sznol M, Logan TF, Richards J, Michener T, Balogh A, Heller KN, Hodi FS (2012) Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol 13:459–465. https://doi.org/10.1016/S1470-2045(12)70090-6 CrossRefPubMed

Di Giacomo AM, Ascierto PA, Pilla L, Santinami M, Ferrucci PF, Giannarelli D, Marasco A, Rivoltini L, Simeone E, Nicoletti SV, Fonsatti E, Annesi D, Queirolo P, Testori A, Ridolfi R, Parmiani G, Maio M (2012) Ipilimumab and fotemustine in patients with advanced melanoma (NIBIT-M1): an open-label, single-arm phase 2 trial. Lancet Oncol 13:879–886. https://doi.org/10.1016/S1470-2045(12)70324-8 CrossRefPubMed

Maio M, Grob JJ, Aamdal S, Bondarenko I, Robert C, Thomas L, Garbe C, Chiarion-Sileni V, Testori A, Chen TT, Tschaika M, Wolchok JD (2015) Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial. J Clin Oncol. 33(10):1191–1196. https://doi.org/10.1200/JCO.2014.56.6018 CrossRefPubMedPubMedCentral

Di Giacomo AM, Ascierto PA, Queirolo P, Pilla L, Ridolfi R, Santinami M, Testori A, Simeone E, Guidoboni M, Maurichi A, Orgiano L, Spadola G, Del Vecchio M, Danielli R, Calabrò L, Annesi D, Giannarelli D, Maccalli C, Fonsatti E, Parmiani G, Maio M (2015) Three-year follow-up of advanced melanoma patients who received ipilimumab plus fotemustine in the Italian Network for Tumor Biotherapy (NIBIT)-M1 phase II study. Ann Oncol 26(4):798–803. https://doi.org/10.1093/annonc/mdu577 CrossRefPubMed

Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD (2015) Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 2 373(1):23–34. https://doi.org/10.1056/NEJMoa1504030 CrossRefPubMedPubMedCentral

Di Giacomo AM (2015) A randomized, phase III study of fotemustine versus the combination of fotemustine and ipilimumab or the combination of ipilimumab and nivolumab in patients with metastatic melanoma with brain metastasis: the NIBIT-M2 trial. J Clin Oncol. https://doi.org/10.1200/jco.2015.33.15_suppl.tps9090 CrossRef

10.

Long GV, Atkinson V, Lo S, Sandhu S, Guminski AD, Brown MP, Wilmott JS, Edwards J, Gonzalez M, Scolyer RA, Menzies AM, McArthur GA (2018) Combination nivolumab and ipilimumab or nivolumab alone in melanoma brain metastases: a multi centre randomised phase 2 study. Lancet Oncol 19(5):672–681. https://doi.org/10.1016/S1470-2045(18)30139-6 CrossRefPubMed

11.

Tawbi HAH, Forsyth PAJ, Algazi AP, Hamid O, Hodi FS, Moschos SJ, Khushalani N, Gonzalez R, Lao C, Postow M, Atkins MB, Ernstoff M, Puzanov I, Kudchadkar R, Thomas R, Tarhini A, Jiang J, Avila A, Demelo S, Margolin K (2017) Efficacy and safety of nivolumab (NIVO) plus ipilimumab (IPI) in patients with melanoma (MEL) metastatic to the brain: Results of the phase II study CheckMate 204. J Clin Oncol. https://doi.org/10.1200/JCO.2017.35.15_suppl.9507 CrossRef

12.

Chatterjee A, Rodger EJ, Eccles MR (2017) Epigenetic drivers of tumourigenesis and cancer metastasis. Semin Cancer Biolpii. https://doi.org/10.1016/j.semcancer.2017.08.004 CrossRef

13.

Maio M, Covre A, Fratta E, Di Giacomo AM, Taverna P, Natali PG, Coral S, Sigalotti L (2015) Molecular pathways: at the crossroads of cancer epigenetics and immunotherapy. Clin Cancer Res 21(18):4040–4047. https://doi.org/10.1158/1078-0432.CCR-14-2914 CrossRefPubMed

14.

Sigalotti L, Fratta E, Coral S, Maio M (2014) Epigenetic drugs as immunomodulators for combination therapies in solid tumors. Pharmacol Ther 142(3):339–350. https://doi.org/10.1016/j.pharmthera.2013.12.015 CrossRefPubMed

15.

Covre A, Coral S, Di Giacomo AM, Taverna P, Azab M, Maio M (2015) Epigenetics meets immune checkpoints. Semin Oncol 42(3):506–513. https://doi.org/10.1053/j.seminoncol.2015.02.003 CrossRefPubMed

16.

Di Giacomo AM, Covre A, Taverna P, Coral S, Amato G, Keer HN, Lowder J, Giannarelli D, Azab M, Maio M (2016) A phase Ib study combining the second-generation DNA hypomethylating agent (DHA) guadecitabine (SGI-110) and ipilimumab in patients with metastatic melanoma: The NIBIT-M4 study. J Clin Oncol. https://doi.org/10.1200/JCO.2016.34.15_suppl.TPS9595 CrossRef

17.

Di Giacomo AM, Covre A, Finotello F, Rieder D, Sigalotti L, Fazio C, Cutaia O, Bock C, Petitprez F, Lacroix L, Lowder J, Fridman WH, Sautès-Fridman C, Trajanoski Z, Maio M (2018) Epigenetic tumor remodelling to improve the efficacy of immune checkpoint blockade: the NIBIT-M4 clinical trial. Cancer Res 78(13 Supplement):CT059. https://doi.org/10.1158/1538-7445.AM2018-CT059 CrossRef

18.

Issa JJ, Roboz G, Rizzieri D, Jabbour E, Stock W, O’Connell C, Yee K, Tibes R, Griffiths EA, Walsh K, Daver N, Chung W, Naim S, Taverna P, Oganesian A, Hao Y, Lowder JN, Azab M, Kantarjian H (2015) Safety and tolerability of guadecitabine (SGI-110) in patients with myelodysplastic syndrome and acute myeloid leukaemia: a multicentre, randomised, dose-escalation phase 1 study. Lancet Oncol 16(9):1099–1110. https://doi.org/10.1016/S1470-2045(15)00038-8 CrossRefPubMedPubMedCentral

19.

Calabrò L, Morra A, Fonsatti E, Cutaia O, Amato G, Giannarelli D, Di Giacomo AM, Danielli R, Altomonte M, Mutti L, Maio M (2013) Tremelimumab for patients with chemotherapy-resistant advanced malignant mesothelioma: an open-label, single-arm, phase 2 trial. Lancet Oncol 14(11):1104–1111. https://doi.org/10.1016/S1470-2045(13)70381-4 CrossRefPubMed

20.

Calabrò L, Morra A, Fonsatti E, Cutaia O, Fazio C, Annesi D, Lenoci M, Amato G, Danielli R, Altomonte M, Giannarelli D, Di Giacomo AM, Maio M (2015) Efficacy and safety of an intensified schedule of tremelimumab for chemotherapy-resistant malignant mesothelioma: an open-label, single-arm, phase 2 study. Lancet Respir Med 3(4):301–309. https://doi.org/10.1016/S2213-2600(15)00092-2 CrossRefPubMed

21.

Alley EW, Lopez J, Santoro A, Morosky A, Saraf S, Piperdi B, van Brummelen E (2018) Clinical safety and activity of pembrolizumab in patients with malignant pleural mesothelioma (KEYNOTE-028): preliminary results from a non-randomised, open-label, phase 1b trial. Lancet Oncol 18(5):623–630. https://doi.org/10.1016/S1470-2045(17)30169-9 CrossRef

22.

Quispel-Janssen J, van der Noort V, de Vries JF, Zimmerman M, Lalezari F, Thunnissen E, Monkhorst K, Schouten R, Schunselaar L, Disselhorst M, Klomp H, Hartemink K, Burgers S, Buikhuisen W, Baas P (2018) PD-1 blockade with nivolumab in patients with recurrent Malignant Pleural Mesothelioma. J Thorac Oncol. https://doi.org/10.1016/j.jtho.2018.05.038 CrossRefPubMed

23.

Calabrò L, Morra A, Giannarelli D, Amato G, D’Incecco A, Covre A, Lewis A, Rebelatto MC, Danielli R, Altomonte M, Di Giacomo AM, Maio M (2018) Tremelimumab combined with durvalumab in patients with mesothelioma (NIBIT-MESO-1): an open-label, non-randomised, phase 2study. Lancet Respir Med 6(6):451–460. https://doi.org/10.1016/S2213-2600(18)30151-6 CrossRefPubMed

24.

Calabrò L, Morra A, Cornelissen R, Aerts J, Maio M (2018) Immune checkpoint blockade therapy of mesothelioma: a clinical and radiological challenge. Cancer Immunol Immunother. https://doi.org/10.1007/s00262-018-2191-3 CrossRefPubMed

25.

Russo V, Chiarucci C, Lofiego MF, Fazio C, Bertocci E, Cutaia O, Giacobini G, Lazzeri A, Lamboglia A, Altomonte M, Tunici P, Covre A, Maio M (2018) Fourteenth meeting of the network Italiano per la Bioterapia dei Tumori (NIBIT) on cancer bio-immunotherapy, Siena, Italy, October 13–15, 2016. Cancer Immunol Immunother 67(6):1023–1030. https://doi.org/10.1007/s00262-017-2078-8 CrossRefPubMed

Title: The Italian Network for Tumor Bio-Immunotherapy (NIBIT) Foundation: ongoing and prospective activities in immuno-oncology
Authors: Anna Maria Di Giacomo
Alessia Covre
Gianluca Giacobini
Ramy Ibrahim
Jaclyn Lyman
Pier Giorgio Natali
Michele Maio
Publication date: 01-01-2019
Publisher: Springer Berlin Heidelberg
Published in: Cancer Immunology, Immunotherapy / Issue 1/2019
Print ISSN: 0340-7004
Electronic ISSN: 1432-0851
DOI: https://doi.org/10.1007/s00262-018-2286-x

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

At a glance: The STEP trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 1/2019

Addressing current challenges and future directions in immuno-oncology: expert perspectives from the 2017 NIBIT Foundation Think Tank, Siena, Italy

Recurrent grade 4 panuveitis with serous retinal detachment related to nivolumab treatment in a patient with metastatic renal cell carcinoma

Soluble CTLA-4 as a favorable predictive biomarker in metastatic melanoma patients treated with ipilimumab: an Italian melanoma intergroup study

Phase I/II clinical trial of a Wilms’ tumor 1-targeted dendritic cell vaccination-based immunotherapy in patients with advanced cancer

Prediction of neoepitopes from murine sequencing data

Fighting breast cancer stem cells through the immune-targeting of the xCT cystine–glutamate antiporter

Keynote webinar | Spotlight on antibody–drug conjugates in cancer