Workshop on site and histology - Independent indications in oncology

• Date:
  Thursday, 14 December 2017
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Biological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. This workshop aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment.

Documents

Agenda - Workshop on site and histology - Independent indications in oncology

Reference Number: EMA/CHMP/673240/2017

Registration form - Workshop on site and histology - Independent indications in oncology

Reference Number: EMA/743635/2017

Presentation - Session 1: Definition of a driver. Cellular/tissular mechanisms supporting that a driver becomes a target multiple drivers, mechanisms of resistance (Christian Rolfo)

Presentation - Session 1: Non-clinical models: tumour models - proof of concept (Edward Rosfjord)

Presentation - Session 1: Nonclinical Models: proof of concept (Jan Willem van der Laan)

Presentation - Session 2: Parameters guiding a site/histology - independent drug development (Jan Schellens)

Summary:

Workshop on site and histology - Independent indications in oncology

Presentation - Session 2: The BRAF story (Yibing Yan)

Presentation - Session 3: How could molecular profiling impact histology independent labels in the future? (Marlene Thomas)

Summary:

Workshop on site and histology - Independent indications in oncology

Presentation - Session 3: Designs for basket clinical trials and the exploratory/confirmatory paradigm (Richard Simon)

Presentation - Session 4: What defines the disease and populations? How to deal with large subgroups within an indication? Heterogeneity, lack of historical real-life data, rarest subtype (Jan Bogaerts)

Summary:

Workshop on site and histology - Independent indications in oncology

Presentation - Session 4: Statistical considerations for the development of diagnostic tests (Olivier Collignon)

Presentation - Session 4: Accuracy of diagnostic methods and impact on clinical management : the lymphopath network experience (Philippe Gaulard)

Presentation - Session 4: What have we learnt from the anti PD1- PDL1 story? (Jorge Camarero )

Presentation - Session 5: Design concept for a confirmatory basket trial (Robert Beckman)

Presentation - Session 5: Post-approval confirmatory/supplementary data: registries and observational trials (Vincent Ho)

Summary:

Workshop on site and histology - Independent indications in oncology

Presentation - Session 5: Approval of pembrolizumab (MSI-H/dMMR) and considerations for site-agnostic development of drugs in oncology (Steven Lemery)

Presentation - Session 5: Considerations in development of pembrolizumab in msi-h cancers (Christine Gause)

Presentation - Session 5: Histology independent indications - the HTA view (Anja Schiel)