Immunotherapy as a modality has grown significantly in recent years, primarily due to the number of therapies being approved via the FDA’s accelerated approval program. These approvals are often facilitated through the use of endpoints that can serve as surrogates for “gold standard” clinical trial metrics such as overall survival. Surrogate endpoints for IO clinical trials have been of significant interest recently for various reasons. The discovery of effective novel surrogate endpoints is critical to increase the quality, quantity, and speed at which novel therapies can gain accelerated approval through clinical trials.
As such, on April 5, 2024, SITC held a summit on this topic in order to advance the field of immunotherapy. The goal of this closed-door workshop was to engage experts across the field of immunotherapy to discuss the science behind surrogate endpoints and identify potential endpoints worth pursuing.
The summit organizers created five working groups that focused on specific areas of interest pertaining to surrogate endpoints:
- Working Group 1: IO Endpoints
- Working Group 2: Deep Response Rate
- Working Group 3: Pathologic Evaluation
- Working Group 4: Role of ctDNA
- Working Group 5: Role of Imaging
The organizers selected experts in the field to co-lead each working group. These co-leads selected 7-9 relevant individuals to participate in the working groups. Each working group participated in an individualized survey and met twice prior to the summit to refine the major challenges, solutions, and stakeholders related to their focus area. These findings were distilled into a presentation that was shared at the larger summit. The summit included presentations from all five working groups along with open discussion with the full group.