June 28, 2018
SARC (Sarcoma Alliance for Research Through Collaboration) is pleased to report the positive results of their osteosarcoma trial of regorafenib. The goal of improving progression-free survival for patients receiving regorafenib on this study has been met.
Following the presentation at ASCO in June 2018 by Florence Duffaud, MD, on behalf of the French Sarcoma Group and Unicancer, SARC convened the study’s Data Monitoring Committee (DMC) to review the unblinded data from SARC024 osteosarcoma group. The DMC determined that given the unequivocal and statistically significant progression-free survival data, there is no need to enroll additional patients in this study (SARC024-NCT02048371). All patients receiving placebo in this osteosarcoma group will be offered regorafenib, and patients currently receiving regorafenib will continue as per the study protocol.
“There have been many trials in the past 10 to 20 years demonstrating no evidence of benefit for people with metastatic osteosarcoma. Now, in my opinion, these data, along with similar data from the French REGOBONE study, serve as sound justification to use regorafenib for patients with metastatic osteosarcoma,” said overall study Principal Investigator Dr. Robert Maki, MD, PhD.
“The encouraging results of this study are an example of how the environment of collaborative research can lead to important breakthroughs that improve outcomes for patients with sarcoma,” said Denise Reinke, President and CEO of SARC.
On behalf of SARC and Dr. Maki, along with the cohort PIs Dr. Lara Davis and Dr. Christopher W. Ryan and all the SARC024 investigators, we appreciate all the patients and their families who agreed to be a part of this important study.
A full manuscript report is being prepared. More details will be announced.
SARC024 is an investigator-initiated study sponsored by SARC with support and drug from Bayer Pharmaceuticals. SARC024 is a study evaluating oral regorafenib in patients with refractory liposarcoma, osteogenic sarcoma, and Ewing sarcomas. This news release is related specifically to the osteosarcoma group of this trial.