Starting the Fight in the Tumor: Expert Recommendations for the Development of Human Intratumoral Immunotherapy (HIT-IT)
(1) Marabelle A (2) Andtbacka R (3) Harrington K (4) Melero I (5) Leidner R (6) de Baere T (7) Robert C (8) Ascierto PA (9) Baurain JF (10) Imperiale M (11) Rahimian S (12) Tersago D (13) Klumper E (14) Hendriks M (15) Kumar R (16) Stern M (17) Ohrling K (18) Massacesi C (19) Tchakov I (20) Tse A (21) Douillard JY (22) Tabernero J (23) Haanen J (24) Brody J
(1) Marabelle A (2) Andtbacka R (3) Harrington K (4) Melero I (5) Leidner R (6) de Baere T (7) Robert C (8) Ascierto PA (9) Baurain JF (10) Imperiale M (11) Rahimian S (12) Tersago D (13) Klumper E (14) Hendriks M (15) Kumar R (16) Stern M (17) Ohrling K (18) Massacesi C (19) Tchakov I (20) Tse A (21) Douillard JY (22) Tabernero J (23) Haanen J (24) Brody J
A European Society for Medical Oncology (ESMO)-sponsored expert meeting was held in Paris on 08 March 2018 which comprised 11 experts from academia, 11 experts from the pharmaceutical industry and two clinicians who were representatives of ESMO. The focus of the meeting was exclusively on the intratumoral injection/delivery of immunostimulatory agents with the aim of harmonizing the standard terms and methodologies used in the reporting of human intratumoral immunotherapy (HIT-IT) clinical trials to ensure quality assurance and avoid a blurring of the data reported from different studies. The goal was to provide a reference document, endorsed by the panel members, that could provide guidance to clinical investigators, pharmaceutical companies, ethics committees, independent review boards, patient advocates and the regulatory authorities, and promote an increase in the number and quality of HIT-IT clinical trials in the future. Particular emphasis was placed not only on the development of precise definitions to facilitate a better understanding between investigators, but also on the importance of systematic serial biopsies as a driver for translational research and the need for the recording and reporting of data, to facilitate a better understanding of the key processes involved.
Author Info:
(1) Gustave Roussy, Universite Paris-Saclay, Departement d'Innovation Therapeutique et d'Essais Precoces, Villejuif, France. (2) Surgical Oncology Department of Surgery, Huntsman C
ancer Institute, University of Utah, Salt Lake City, USA. (3) The Royal Marsden/The Institute of Cancer Research, National Institute for Health Research Biomedical Centre, London, UK. (4) Clinica Universidad de Navarra and CIBERONC. Pamplona Spain. (5) Providence Cancer Center, Earle A. Chiles Research Institute, Portland, Oregon, USA. (6) Gustave Roussy, Universite Paris-Saclay, Department of Image Guided Therapy, Villejuif, France. (7) Department of Dermatology, Institute Gustave-Roussy, Paris, France. (8) Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy. (9) King Albert II Cancer Institute, Cliniques Universitaires St Luc, Universite Catholique de Louvain, Brussels Belgium. (10) Nektar Therapeutics, San Francisco, USA. (11) Idera Pharmaceuticals, Exton, Pennsylvania, USA. (12) Clinical Development,Bioncotech Therapeutics, Madrid, Spain. (13) Lytix Biopharma AS, Oslo, Norway. (14) Aduro Biotech, Eindhoven, The Netherlands. (15) MedImmune, LLC, Gaithersburg, Maryland, USA. (16) Roche, Zurich, Switzerland. (17) Amgen Europe GmbH, Zug, Switzerland. (18) Global Product Development Oncology,Pfizer, New York, USA. (19) Eisai Ltd, Hatfield, UK. (20) Oncology Early Development, Merck & Co., Inc., Kenilworth, New Jersey, USA. (21) Chief Medical Officer, ESMO, Viganello-Lugano, Switzerland. (22) Medical Oncology Department, Vall d' Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. (23) Division of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands. (24) Department of Medicine, Division of Hematology and Oncology, Icahn School of Medicine at Mount Sinai Hospital, New York, USA.
