Hyatt Regency Washington on Capitol Hill
(400 New Jersey Ave NW, Washington, DC 20001
Goals and Objectives:
To identify key issues in both nonclinical toxicology and clinical safety evaluations of cancer immunotherapeutic products.
- To seek novel endpoints other than the traditional endpoints which will capture unique characteristics related to cancer immunotherapeutic products.
- To discuss possible modifications of the traditional endpoints used in oncology clinical trials. For example, whether novel immune-related response criteria are more suitable to capture the spectrum of clinical patterns of anti-tumor response for cancer immunotherapeutic products than standard response criteria and the applicability of the criteria to PFS, and whether an intermediate clinical endpoint and clinical benefit endpoints are more suitable.
- To discuss statistical methods appropriate for analyzing and reporting the treatment effects in immuno-oncology trials.
- To discuss clinical situations unique in immuno-oncology trials, such as consideration of continued treatment with immunotherapeutic products based on potential for delayed anti-tumor responses despite initial evidence of disease progression.
- To discuss the design of immuno-oncology trials that consider new and modified endpoints, new statistical assumptions and methods, unique characteristics of cancer immunotherapeutic products, and applicability and generalization of these concepts across tumor types and immunotherapeutic product classes.
Who Should Attend:
This workshop will be open to the public. The primary audience will include stakeholders from academia, industry, advocacy organizations, and government regulatory agencies involved in development of novel cancer immunotherapeutic products.