DelMar Pharmaceuticals provides update on VAL-083 studies
DelMar Pharmaceuticals presented clinical updates from the company's ongoing first- and second-line trials in patients with MGMT-unmethylated glioblastoma multiforme at a key opinion leader forum focused on brain tumors and the role of VAL-083 to address the unmet medical need in GBM during the 2019 American Society of Clinical Oncology annual meeting in Chicago, IL. At the KOL forum, the company provided an update on the ongoing Phase 1/2 clinical study investigating the front line treatment of VAL-083 with radiation therapy in newly diagnosed MGMT-unmethylated GBM. This trial is being conducted at the Sun Yat-sen University Cancer Center in Guangzhou, China in collaboration with Guangxi Wuzhou Pharmaceutical Company. The trial is designed to enroll up to 30 patients to determine if first-line therapy with VAL-083 treatment, in lieu of first-line temozolomide, improves progression free survival. As of May 17, eighteen patients have been enrolled in the trial. Of these patients, fifteen have received their post-cycle 3 MRI and investigator assessment, and ten have received their post-cycle 7 MRI and investigator assessment. Two patients have not been on the study long enough to reach their first assessment, and one patient died before their first assessment. Assessments are based on the trial investigator's clinical and radiologic assessment, according to the Response Assessment in NeuroOncology (RANO) criteria. For the fifteen patients who have received at least one assessment, eight patients were assessed with a best response of "Complete Response" (8/15, 53.3% CR) and seven patients were assessed with a best response of "Stable Disease" (7/15, 46.7% SD). Fourteen of the eighteen patients were still alive at the data cut-off date. The company also provided an update on the ongoing second-line Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated, Bevacizumab-naive recurrent GBM. This study is being conducted in collaboration with The University of Texas MD Anderson Cancer Center. This biomarker-driven trial has been amended to enroll up to 83 patients (35 with a starting dose of 40 mg/m2; 48 with a starting dose of 30 mg/m2) to determine the potential of VAL-083 treatment to improve overall survival compared to historical reference control of 7.2 months with lomustine. As of May 5, 51 patients have been enrolled, 35 patients at a starting dose of 40 mg/m, and 16 patients at a starting dose of 30 mg/m. For the 47 patients who have been on study long enough to be assessed at the post-cycle 2 MRI: 9/35 (25.7%) patients initially receiving 40 mg/m exhibited "Stable Disease" per investigator assessment at the end of cycle 2; 4/12 (33.3%) patients initially receiving 30 mg/m2 exhibited "Stable Disease" per investigator assessment at the end of cycle 2. Consistent with prior studies, myelosuppression is the most common adverse event in both ongoing clinical trials.