The first patient with newly diagnosed glioblastoma multiforme has been dosed with the first-in-class small molecule enzastaurin in combination with temozolomide and radiotherapy in the phase 3 ENGAGE clinical trial with an aim of determining the overall survival outcome of the drug in this patient population.
The first patient with newly diagnosed glioblastoma multiforme (GBM) has been dosed with the first-in-class small molecule enzastaurin (DB102) in combination with temozolomide (Temodar) and radiotherapy in the phase 3 ENGAGE clinical trial (NCT03776071) with an aim of determining the overall survival (OS) outcome of the drug in this patient population, announced Denova Biopharma, in a press release.1
The target enrollment for the randomized, double-blind, placebo-controlled global study is over 300 patients. Currently, recruitment for the study is ongoing. In addition to OS, the study is evaluating the association of biomarkers and clinical outcomes, response rates, progression-free survival, and the number of patients with adverse events, as secondary end points.
"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, MD, chief medical officer, Denova Biopharma, in a statement.
In July 2020, enzastaurin was granted Fast Track designation by the FDA for the treatment of newly diagnosed GBM. With this designation in tow, the developer aims to address the limited survival benefit observed with other agents, like temozolomide backbone therapy, given to patients newly diagnosed GBM.2
"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”, stated Yang, in the press release.1
In ENGAGE, patients with histologically confirmed disease who had no prior treatment for brain tumors are eligible to enroll. Any biopsy or tumor resection in patients must have been completed at least 5 weeks prior to study enrollment. Patients are also required to have adequate organ function in order to enroll. The study excludes those with active infection and other medical illnesses, as well as those receiving concurrent therapy with an anticoagulant.
1. First patient dosed in biomarker-guided phase 3 study of DB102 (enzastaurin) in patients with newly diagnosed glioblastoma (GBM). New release. Denova Biopharma. January 8, 2021. Accessed January 11, 2021. https://bit.ly/35qFj95
2. FDA grants Fast Track designation for DB102 in patients with newly-diagnosed glioblastoma (GBM). News release. Denova Biopharma. July 17, 2020. Accessed January 11, 2021. https://bit.ly/2XwDR0w