In this webinar we reviewed key issues related to endpoints in immuno-oncology, with a brief overview of the four different sets of criteria for response assessment in immunotherapy. Then we reviewed the novel approaches both for the design and analysis of clinical trials, including the assessment of the net benefit through the use of generalized pairwise comparison (GPC).
KEY LEARNING OBJECTIVES:
In this webinar, featured speakers:
- Reviewed key issues in the recent literature related to endpoints in immuno-oncology, with a brief overview of the four different sets of criteria that have been proposed for response assessment in immunotherapy.
- Used examples from the recent literature to illustrate the limitations of current statistical methods in the assessment of progression-free survival and overall survival,
- Reviewed the novel approaches that have been proposed both for the design and analysis of clinical trials, including the assessment of the net benefit through the use of generalized pairwise comparison (GPC)
Questions and answers during the webinar: QA – Webinar Benefit from Immunotherapy
ABSTRACT:
The management of cancer patients in clinical practice is undergoing a revolution due to the introduction of effective immunotherapy. Several different strategies currently rely on harnessing the immune system to fight tumors, leading to unprecedented therapeutic success. However, immunotherapy has also created the need to revisit the assessment of treatment benefit, possibly because its mechanism of action leads to effects on short- and long-term outcomes in a manner that differs from those of other modalities. For example, clinical trials of immune checkpoint inhibitors have disclosed novel issues related to the assessment of objective responses and have reinstated overall survival as a reliable primary endpoint, often to the detriment of progression-free survival (PFS). Moreover, pseudoprogression has become an issue in some tumor types, and the duration of responses has emerged as a relevant endpoint. In parallel, the limitations of current statistical methods of survival analysis that are based on the proportional-hazards assumption have become more apparent, and novel methods have been proposed.
SPEAKERS:
