FDA Approves Efficacy Trial for Novel Glioblastoma Drug

The US Food and Drug Administration (FDA) has OKed the initiation of a phase 2b clinical trial assessing an investigative combination therapy for the treatment of patients with newly diagnosed glioblastoma.

Denovo Biopharma has been granted approval for a study that will gauge the efficacy of their recently acquired DB102 treatment in combination with radiation and temozolomide (Temodar). Currently, temozolomide is among just a few therapies approved by the FDA for glioblastoma, and has been shown to provide a median survival advantage of 2.5 months to patients when added with surgery and radiation therapy.

Glioblastoma multiforme is a rare form of cancer, yet the most common form of adult primary malignant brain cancer. Currently, 18,000 patients are newly diagnosed annually, and 13,000 patients die annually. Fewer than 5% of patients survive 5 or more years.

The Denovo trial is intended to expand on the company’s effort to identify a genetically-enriched patient population with diffuse large B-cell lymphoma (DLBCL) who could benefit from the investigative therapy. DB102 was acquired from Eli Lilly & Co., shortly before Denovo discovered novel genetic biomarker DGM1.

Investigators believe this biomarker could potentially predict DB102 response in patients with DLBCL. As DGM1 is a germline biomarker, it could also predict a survival benefit in patients with glioblastoma treated with DB102 plus temozolomide.

The company intends to enroll about 200 patients newly diagnosed with glioblastoma for its phase 2b trial. Lei Zhang, MD, chief medical officer of Denovo, expressed excitement for the FDA’s approval of their Investigational New Drug (IND) application, as well as for the start of this hopefully pivotal study into glioblastoma.

“GBM remains one of the toughest cancers to treat and numerous attempts have failed including anti-PD-1 antibodies,” Zhang said in a statement. “DB102 treatment guided by the novel DGM1 biomarker could potentially provide a breakthrough for this severely unmet medical need.”