EORTC Phase II trabectedin study opens for meningioma patients

EORTC and PharmaMar announced today the opening of a Phase II trial (EORTC 1320 trial) with YONDELIS (trabectedin) in patients with recurrent high grade meningioma to assess its efficacy and safety compared to standard of care.

"EORTC trial 1320 is coordinated by the EORTC Brain Tumor Group and plans to accrue 86 patients with recurrent grade II or III meningioma at 47 sites located in ten countries, including Austria, Belgium, France, Germany, Italy, Norway, Spain, Switzerland, The Netherlands, and the UK," added Dr Vassilis Golfinopoulos, EORTC Medical Director. "We are pleased that this EORTC sponsored trial is supported by an Educational Grant from PharmaMar."

The principal investigator of the study, Matthias Preusser, MD Medical University, pointed out "preclinical data has already pointed to trabectedin and its role in targeting the tumor microenvironment as a potential way to tackle malignant meningioma tumors". The study coordinator added that "the results of this trial will help us assess whether this drug should be further investigated as a therapeutic option for patients with this disease, who are now in need of alternative treatments."

This is a multicenter, interventional, randomized, open label and comparative phase II trial that will assess whether trabectedin shows antitumor activity in patients with recurrent high grade (grade II or III) meningioma. The primary endpoint of the study is progression-free survival. Secondary objectives will include progression-free survival at 6 months, best overall response, safety and quality of life of the patients.

"We are glad that patient enrollment is happening quickly, and we hope the study will continue at this pace", mentioned Emilie Le Rhun, MD, University Hospital of Lille, who enrolled the first two patients. "People living with this disease are eager to have more therapeutic options."