Paediatric Strategy Forum

ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration

8th Paediatric Strategy Forum on Multi-targeted kinase inhibitors in Bone Sarcomas

30 November & 1 December 2021
4pm to 8.30pm CET (10am-2.30pm EST / 7am-11.30am PST) each day
Virtual

Background and objectives

The Eighth Multi-Stakeholder Paediatric Strategy Forum, organised by ACCELERATE in collaboration with the European Medicines Agency (EMA) and with the participation of the U.S. Food and Drug Administration (FDA) will focus on Multi-targeted kinase inhibitors in Bone Sarcomas.

Background: Paediatric Strategy Forums have been created to evaluate the current state of the science, facilitate dialogue and provide an opportunity for constructive discussions between relevant stakeholders (patient advocates, clinicians, academics, biotechnology/pharmaceutical companies and regulators) on specific topics in an open forum to assure development of medicines in the best interests of children and adolescents with cancer. The goal of these meetings is to share information, to facilitate the development of innovative medicines and ultimately their introduction into the standard-of-care of children with malignancies.
The summary of the first six Paediatric Strategy Forums held in January and November 2017, September 2018, April 2019, January 2020 and January 2021 on ALK inhibition, mature B-cell malignancies, checkpoint inhibitors in combination, acute myeloid leukaemia, epigenetic modifiers, and ALK inhibition respectively can be found here.

Multi-targeted kinase inhibitors in bone sarcomas: Curative treatment for bone sarcomas represents an unmet need. Multi-targeted kinase inhibitors (mTKI) have demonstrated biological activity against a wide range of sarcomas in vitro, in vivo and in clinical trials in sarcoma patients. There are many mTKIs under investigation and in clinical practice and there at least 7 clinical trials exploring the activity of mTKIs in osteosarcoma.

The Paediatric Strategy Forum will use osteosarcoma as a “proof of concept” for other sarcomas and explore key issues. The Forum will address: – i) are there mTKIs of sufficient relevance (based on biology, pre- and clinical evidence) in bone sarcomas that warrant further development? ii) are there any mTKIs not of relevance in bone sarcomas?; iii) What should the approach be to identifying relevant biomarkers?

In addition i) when moving mTKIs into combination trials in bone sarcomas, how should drug selection, dosing and schedule be approached in order to minimize toxicity? ii) during what stage of therapy should mTKIs be employed? and iii) what patient populations with bone sarcomas should be evaluated in combination with chemotherapy and other novel agents including immunotherapy? will be addressed.The existing trials of mTKIs in bone sarcomas and the relevant biology of mTKIs will be reviewed, and the needs for mTKI inhibitors in osteogenic sarcoma and Ewing sarcoma will be discussed. NTRK and RET inhibitors will not be addressed.

Forum Goals: to summarise the current status of the development of mTKIs in bone sarcomas and to define the best scientific strategy for their future development.

Forum Output: publication of a summary and manuscript from all participants addressing the challenges and documenting the conclusions of the meeting. Potentially further specific meetings relating to areas which require more in-depth discussion will be arranged.

Participation: possible only by invitation or by submitting an Expression of Interest (see below) before the 13 September 2021.
Invited participants will be informed in due time.

Submit your Expression of Interest: The call for expressions of interest is open now – click on the relevant box below.

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ACCELERATE is generously supported by The Andrew McDonough B+ Foundation



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