Combining immune therapy and targeted therapies Educational session

17IN - MDICT report (consensus report)

Presentation Number
17IN
Lecture Time
10:00 - 10:20
Speakers
  • Lesley Seymour (Kingston, CA)
Location
Room Scene AB, Paris Marriott Rive Gauche, Paris, France
Date
06.03.2018
Time
09:00 - 10:30
Authors
  • Lesley Seymour (Kingston, CA)
  • Giuseppe Giaccone (Washington DC, US)
  • Josep Tabernero (Barcelona, ES)

Abstract

Background

The ‘Methodology for the Development of Innovative Cancer Therapies’ (MDICT) task force was originally established in 2006 to provide practical guidance on the development of anticancer targeted agents. The task force published a number of recommendations. [1] [2] [3] [4] Although originally focused on targeted agents, for 2018, it was decided to convene the task force to examine issues in the development of immune based therapies. [1] Booth CM, Calvert AH, Giaccone G, Lobbezoo MW, Seymour LK, Eisenhauer EA. Endpoints and other considerations in phase I studies of targeted anticancer therapy: Recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies (MDICT). EJC 2008;44(1):19–24. [2] Booth CM, Calvert AH, Giaccone G, Lobbezoo MW, Eisenhauer EA, Seymour LK. Design and conduct of phase II studies of targeted anticancer therapy: Recommendations from the task force on methodology for the development of innovative cancer therapies (MDICT). EJC 2008;44:125–9. [3] Goodwin R, Giaccone G, Calvert H, Lobbezoo M, Eisenhauer EA. Targeted agents: How to select the winners in preclinical and early clinical studies? Eur J Cancer 2012;48:2170–8. [4] Seymour LK, Calvert AH, Lobbezoo MW, Eisenhauer EA, Giaccone G. Design and conduct of early clinical studies of two or more targeted anticancer therapies: Recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies.

Methods

Participants included experts from academic centres as well as from industry and regulatory authorities. The mandate of the meeting was to review current knowledge and discuss and make recommendations regarding the design and conduct of early clinical studies of combinations of immune based anticancer agents.

Results

Response patterns and current criteria were reviewed. Critical issues were identified regarding capacity, trial design, optimal endpoints, data sharing and the publication of results. A structured discussion was conducted to allow recommendations on data needed to justify a proposed combination, optimal endpoints and design.

Conclusions

At the end of the MDICT meeting, agreed recommendations were summarized and then presented for feedback to the audience attending TAT2018.

Conclusions

At the end of the MDICT meeting, agreed recommendations were summarized and then presented for feedback to the audience attending TAT2018.

Clinical trial identification

Not applicable

Legal entity responsible for the study

Queens University

Funding

Has not received any funding

Disclosure

J. Tabernero: Has served on advisory boards for Bayer, Boehringer Ingelheim, Genentech/Roche, Lilly, MSD, Merck Serono, Novartis, Roche, Sanofi, Symphogen and Taiho. All other authors have declared no conflicts of interest.

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