17 April 2018 EMA/242738/2018

Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients 5-6 September 2018

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Background and objectives The third multi-stakeholder Paediatric Strategy Forum, jointly organised by EMA and ACCELERATE will focus on checkpoint inhibitors used in combination therapy, in children and adolescents. Paediatric Strategy Forums have been created to facilitate dialogue and provide an opportunity for constructive interactions between relevant stakeholders (patients/patient representatives, clinicians, academics, pharmaceutical companies and regulators) on topics requiring open discussion on development of medicines in the best interests of children and adolescents with cancer. The goal of this meeting is to share information, in a pre-competitive setting, to facilitate the developments of innovative medicines and ultimately their introduction into the standard-of-care of children with malignancies. The first two Paediatric Strategy Forums were held at EMA in January and November 2017 on ALK inhibition and mature B-cell malignancies, respectively. Both can be found in the Paediatric medicines: Workshops page in the European Medicines Agency website. Immune checkpoint inhibitors have shown impressive success in some adult malignancies, in particular, monoclonal antibodies that block the interaction between programmed death ligand 1 (PDL1) on the surface of tumor or antigen-presenting cells, and programmed death 1 (PD-1) on the surface of lymphocytes. Many of these products have now been licensed as first or second line treatments for adult malignancies. Furthermore, the combination of antibodies targeting PD-1 with those targeting the immune checkpoint molecule CTLA-4 has shown particularly high response rates especially in adult patients with metastatic melanoma. Early phase trials in children of single agent checkpoint inhibitors are currently being presented. High response rates are being observed in some cancers common to children and adults, for example in Hodgkin lymphoma. However, these results appear not to be reflected in typical paediatric malignancies. Some combination studies are in progress and others are planned. It therefore seems opportune to review the early results of these early phase trials in children and consider opportunities for paediatric studies in which check-point inhibitors are used in combination including also possible other approaches. This Forum will review the immunological environment of paediatric malignancies, results from the use of checkpoint inhibitors in early phase clinical studies in paediatrics, strategies combining checkpoint inhibitors with other products and alternative immunotherapy strategies. The output will be a published summary from all participants addressing the challenges and documenting the conclusions.

Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients EMA/242738/2018

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List of speakers and moderators To be announced

Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients EMA/242738/2018

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Draft programme Introduction Immunological environment of paediatric malignancy Development of checkpoint inhibitors in adults with lessons relevant to paediatrics Checkpoint inhibitors in early phase clinical studies Checkpoint inhibitors - Biallelic mismatch repair, MSI status and tumour burden as potential predictive biomarkers Strategies combining checkpoint inhibitors with other products Alternative immunotherapy strategies Strategic discussion Conclusions

Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients EMA/242738/2018

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Paediatric strategy forum for medicinal product development of

Apr 17, 2018 - Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients. EMA/242738/2018. Page 3/4. List of speakers and moderators. To be announced ...

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