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Sarcoma Alliance for Research Through Collaboration
Contact: Charlene Calcagno
SARC Investigator-Initiated Osteosarcoma Study Shows Positive Results of Regorafenib
JUNE 28, 2018 – ANN ARBOR, MICH.

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.

About the PIs
The osteosarcoma group Principal Investigators are Christopher W. Ryan, MD, Medical Oncologist, Oregon Health and Science University; and Lara Davis, MD, Assistant Professor, Departments of Medicine and Pediatrics,  Oregon Health and Science University. The SARC024 overall Principal Investigator is Robert Maki, MD, PhD, Professor of Medicine, Northwell Cancer Institute / Zucker School of Medicine at Hofstra-Northwell, and Professor, Cold Spring Harbor Laboratory.

About SARC
SARC (Sarcoma Alliance for Research Through Collaboration) is a US-based, non-profit sarcoma research cooperative solely dedicated to fostering progress in the prevention and treatment of sarcoma to improve patient outcomes and ultimately find a cure. SARC serves the sarcoma research community in the United States as well as in Europe. 

About Regorafenib
Regorafenib (Stivagara®) is an oral multi-kinase inhibitor developed by Bayer which targets angiogenic, stromal, and oncogenic receptor tyrosine kinase. Regorafenib shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition. Since 2009 it has been studied as a potential treatment option in multiple tumor types.

What is Sarcoma?
Sarcomas are cancers of the bony skeleton (the skull, vertebrae, ribs, and extremities), and also the muscle and other tissues attached to, supporting, or joining those bones. Sarcomas can occur in people of all ages. Although there are many different types of sarcomas, it is still a very rare disease. Therefore, few physicians have experience in dealing with sarcomas, so it is not uncommon for it to be difficult to arrive at a diagnosis of sarcoma. This fact is simply a reflection of the rarity of this cancer. SARC and our collaborators are working to advance the science and knowledge of sarcomas.
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© SARC 2018 [FF062718]