Erdinç Nayır, Associate Professor of Internal Medicine and Medical Oncology at VM Medicalpark Mersin Hospital, shared a post on X:
“GBM AGILE Phase II/III trial: Regorafenib did not meet expectations.
In this large adaptive platform trial including newly diagnosed (MGMT-unmethylated) and recurrent glioblastoma:
- No overall survival (OS) benefit
NDU: HR 1.05
RD: HR 1.07
- Higher toxicity observed
- Trial stopped early due to futility
Findings from the earlier REGOMA trial were not confirmed.
Conclusion: Regorafenib is not superior to standard therapies in glioblastoma and has been removed from NCCN guidelines.”
Title: Evaluation of Regorafenib in Newly Diagnosed and Recurrent Glioblastoma: GBM AGILE Phase II/III Bayesian Randomized Platform Trial
Authors: Patrick Y. Wen, Donald A. Berry, Meredith B. Buxton, Howard Colman, John de Groot, Michael Lim, Ingo Mellinghoff, James R. Perry, Michael Weller, Nicholas A. Blondin, Omar H. Butt, Denise M. Damek, Macarena I. de la Fuente, Jan Drappatz, Erin Dunbar, Pierre Giglio, Emma Viktoria Hyddmark, Fabio Iwamoto, Kurt A. Jaeckle, Lyndon Kim, Heather M. Kling, Eudocia Q. Lee, Megan Mantica, Tom Mikkelsen, Burt Nabors, Herbert B. Newton, Jeffrey J. Olson, David Schiff, Tobias Walbert, Shiao-Pei Weathers, Timothy Cloughesy, Andrew B. Lassman
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