Delving Into Imaging Endpoint Strategies for Early & Later-stage Glioblastoma Clinical Trials
Time: 2:15 pm
day: Conference Day One
Details:
- For early phase clinical trials involving a limited number of patients and/or complex tumor types, a tiered approach to recognizing, quantifying, and interpreting radiographic changes is recommended, including the use of digital “flipbooks” and a modified Levin criterion, in order to increase confidence in potential therapeutic changes
- To increase the likelihood of success in later phase trials, we recommend evaluating the proportion of patients exhibiting a meaningful change in growth rate trajectory and progression-free survival (PFS), including calculation of pre-treatment growth rates and use of a “hyperacute” baseline within days of starting experimental therapy
- Historic data suggests objective response rate (ORR) >25%, in combination with a sufficient duration of response (DOR), leads to a meaningful increase in overall survival and a high likelihood of success in late-stage survival studies
