First Patient Dosed in Biomarker-Guided Phase 3 Study of DB102 (Enzastaurin) in Patients with Newly-Diagnosed Glioblastoma (GBM)
SAN DIEGO, Jan. 8, 2021 /PRNewswire/ -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative therapies, today announced dosing of the first patient in its biomarker guided Phase 3 clinical study evaluating the DB102 (enzastaurin) in combination with temozolomide and radiation as first line therapy to treat newly-diagnosed glioblastoma multiforme (GBM). This randomized, double-blind, placebo-controlled global study is to enroll more than 300 patients and the primary outcome measure is overall survival in patients with Denovo Genomic Marker 1 (DGM1). This GBM study has received Phase 3 permission from regulatory agencies from US, Canada, and China, and also gained FDA's Fast Track designation last year.
"This GBM study is the second global Phase 3 trial of DB102 for patients with cancer following our first global Phase 3 trial of DB102 for patients with diffuse large B-cell lymphoma (DLBCL). In both trials, we use DGM1 to identify the patients who will receive the most benefits from DB102 therapy in combination regimens," said Zane Yang, M.D., Denovo's Chief Medical Officer. "GBM remains to be one of the deadliest cancers and the first line drug treatment still relies on temozolomide as the backbone -- many promising anticancer drugs, including anti-PD-1 drugs, have failed to improve upon temozolomide's efficacy. I am hopeful that our innovative approach can bring new hope to patients with this difficult-to-treat condition that continues to have a significant unmet need."
For more information on the DB102 ENGAGE clinical study, visit https://clinicaltrials.gov/ct2/show/NCT03776071
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SOURCE Denovo Biopharma LLC