LBA58 - Results of the randomized, placebo (PL)-controlled phase II study evaluating the efficacy and safety of regorafenib (REGO) in patients (pts) with relapsed advanced or metastatic chordoma, on behalf of the French Sarcoma Group (FSG) and Unicancer
Florence Duffaud, et al.
This randomized non comparative study failed to show any signal of benefit for REGO in pts with advanced/metastatic incurable chordoma, with toxicities in REGO arm leading to early treatment discontinuation in this small group of patients.
LBA59 - LMS-04 study: A randomised, multicenter, phase III study comparing doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin in non-progressive patients as first-line therapy, in patients with metastatic or unresectable leiomyosarcoma - A French Sarcoma Group study
Patricia Pautier, et al.
Dox+Trab combination in 1st-line therapy increases significantly the PFS of met LMS compared to Dox alone, though at the cost of additional expected and manageable toxicity. Benefit in ORR and OS is also observed.
1520O - REGISTRI: Regorafenib in first-line of KIT/PDGFR wild type advanced GIST: Capatalize the A Spanish (GEIS), Italian (ISG) and French Sarcoma Group (FSG) phase II trial
Javier Martin Broto, et al.
The study results approach the prespecified activity threshold. The low recruitment rate could have affected this attainment. Other analysis of secondary endpoints are ongoing. The high percentage of overlooked mutant GIST by Sanger raises the need of NGS in presumed KPWT GIST.
1521O - A phase II biomarker-driven study evaluating the clinical efficacy of an MDM2 inhibitor, milademetan, in patients with intimal sarcoma, an ultra-rare cancer with highly life-threatening unmet medical needs (NCCH1806/MK004)
Yuki Kojima, et al.
Milademetan showed acceptable safety profile with some clinical activity in patients with intimal sarcoma with MDM2 amplification. These results suggest that MDM2 inhibitor may be a potential promising therapeutic option for this life- threatening unmet medical needs.