Imvax’s brain fail

Imvax’s cell therapy-device combo project IGV-001 has failed to meet its primary progression-free survival endpoint in a placebo-controlled glioblastoma trial. But the company still sees a way forward for the asset, based on an overall survival benefit.

The group plans to discuss the data, and the project’s potential regulatory pathway, with the FDA “in the coming months”.

IGV-001 consists of patient-derived tumour cells and an antisense oligonucleotide against insulin-like growth factor type 1 receptor (IGF1R). The tumour antigens are designed to stimulate the patient’s immune cells, while the antisense downregulates IGF1R, a cell growth controller commonly overexpressed in tumours.

In the 99-patient phase 2 trial, patients were implanted with biodiffusion chambers containing either IGV-001 or an inactive solution. The chambers were removed after 48 hours, and after six weeks all patients were treated with standard of care: adjuvant radiotherapy and Merck & Co's Temodar, followed by maintenance Temodar.

Imvax didn’t give details of the PFS results, only saying that there was no statistically significant difference between groups.  

On OS, the company cited a median 20.3 months with IGV-001, versus 14.0 months with placebo, but didn’t give any statistical details.

As for safety, there were no drug-related serious adverse events with IGV-001, Imvax said. Overall, the project’s safety profile was “consistent with” that seen a 33-patient phase 1b study, in which six patients had grade 3 or higher adverse events deemed possibly related to IGV-001. 

According to privately-held Imvax, the average life expectancy for glioblastoma patients is 12-15 months. Temodar itself was approved, back in 2005, based on a 2.5-month improvement in median OS versus radiotherapy alone. This, and the dearth of options in the disease, might help the company’s case. Over to the FDA.

Phase 2 data with IGV-001 in first-line glioblastoma

*Primary endpoint. Source: company release.