RE:RE:RE:RE:ONCY January 2024 slide deck - over 120 panc pts studiedShould read: " ...120 pancreatic patients in ONCY's adaptive pancreatic studies (REO-17 and Goblet)..."
Merck's (MSD) Keynote-001. multicohort, open-label, phase 1 study of pembrolizumab, was an adaptive study that led to accelerated approvals in 2 indications.
In March 2023 - The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs) – rather than single-arm studies -- the “preferred approach” to support accelerated approval.
https://www.raps.org/News-and-Articles/News-Articles/2023/3/FDA-encourages-RCTs-in-accelerated-approval-guidan
ONCY's Goblet and REO-17 were adaptive RCT studes