Denovo Biopharma Receives FDA’s Permission to Proceed with a Biomarker-Guided Phase 2b Clinical Trial with DB102 (Enzastaurin) In First-Line Treatment of Glioblastoma (GBM)

On October 15, 2019 Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, reported FDA’s approval to initiate Denovo’s Phase 2b clinical study of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation and temozolomide (Press release, Denovo Biopharma, OCT 15, 2019, View Source [SID1234542279]).

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Denovo’s GBM clinical study is an extension of its work to identify a genetically-enriched patient population with DLBCL who may benefit from DB102 treatment. After Denovo acquired DB102 from Eli Lilly & Co., it discovered a novel genetic biomarker, DGM1, that is a potentially predictive biomarker for DB102 response in patients with DLBCL. Since DGM1 is a germline biomarker, Denovo found that DGM1 also predicts a survival benefit in patients with GBM treated with DB102 plus temozolomide. Denovo’s clinical trial is expected to enroll approximately 200 patients with newly-diagnosed GBM.

"GBM remains one of the toughest cancers to treat and numerous attempts have failed including anti-PD-1 antibodies. DB102 treatment guided by the novel DGM1 biomarker could potentially provide a breakthrough for this severely unmet medical need," said Lei Zhang, M.D., Denovo Biopharma’s Chief Medical Officer. "We are very excited to receive FDA’s approval of our IND and begin to initiate this potentially pivotal GBM study."

About Glioblastoma

Glioblastoma Multiforme (GBM) is the most common type of adult primary malignant brain cancer, with 18,000 newly-diagnosed patients in the US and 13,000 deaths annually. Standard treatment for patients with newly diagnosed GBM can include surgery followed by radiation and chemotherapy, but treatment options are limited. The five-year survival rate of patients with GBM is less than five percent.