Immunotherapy has shifted the treatment paradigm for many malignancies, but not all cancer types have enjoyed a clinically meaningful response from checkpoint blockade. Therefore combination therapies that allow enhancement of the antitumor immune response are needed. Poly(ADP-ribose) polymerase (PARP) inhibitors may stimulate antigen presentation via increased T cell cytotoxic activity. In preclinical models, the combination of PARP inhibition with anti-PD-L1 therapy compared with each agent alone has been shown to significantly increase the therapeutic efficacy. PARP inhibitors when combined with anti-CTLA-4 therapy in
N/A
Has not received any funding
The author has declared no conflicts of interest.
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.
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.
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.
Not applicable
At the end of the MDICT meeting, agreed recommendations were summarized and then presented for feedback to the audience attending TAT2018.
Queens University
Has not received any funding
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.