FDA Recommends Early Progression to Phase 3 Trials for Sitoiganap for Glioblastoma Treatment

Because of positive results seen to date, the Food and Drug Administration (FDA) has recommended early termination of the ongoing phase 2 clinical trial of sitoiganap (ERC1671; ERC-USA, Irvine, CA) for glioblastoma treatment. The FDA also recommended a randomized confirmatory phase 3 registration trial to support a licensing application in the form of a biologics license application (BLA). If found effective and approved, sitoiganap will be the first available treatments for recurrent glioblastoma. 

In the phase 2 trial (NCT01903330) preliminary survival data demonstrated that sitoiganap treatment combined with bevacizumab maintained median overall survival of 11 months. This result is in comparison to historical controls demonstrating median overall survival of 5.3 months. Sitoiganap treatment activated an immune response (CD3/CD4 count) that correlated with overall survival.

The principal investigator of the ERC1671 clinical trial, Daniela A. Bota, MD, PhD, Vice Dean for Clinical Research, University of California, Irvine School of Medicine, and Medical Director, UCI Health Comprehensive Brain Tumor Program, said, “We are highly reassured that the FDA shares our view that ERC1671 should enter a registration trial and move toward an NDA as soon as possible.”

Apostolos Stathopoulos, MD, PhD, president and chief executive officer of ERC Belgium added, “We are thrilled that the FDA now recognizes the potential of ERC1671 to treat this intractable disease and major unmet medical need. We believe ERC1671 provides significant hope to patients with recurrent glioblastoma and we are grateful to the FDA’s encouragement to aggressively enter into a registration trial.”

Sitoiganap is an advanced immunotherapy that uses both autologous and allogeneic tumor cells lysates to stimulates an immune response to glioblastoma.