- Biotech company Imugene (IMU) has unveiled some positive data from its ongoing phase two study of HER-Vaxx in advanced gastric cancer
- The two-arm study is trialling Imugene’s immunotherapy drug in 68 patients with late-stage gastric cancer
- Interim analysis shows an overall survival hazard ratio of 80 per cent and reduced death risk of 58.2 per cent in the HER-Vaxx plus chemotherapy group compared to the group undergoing chemotherapy alone
- After reviewing the safety and efficacy data, the Independent Data Monitoring Committee (IDMC) didn’t report any safety concerns
- Given the strong signals observed in the data, the IDMC suggests Imugene reduce the number of patients required to finish the study
- Company shares are up a healthy 20 per cent following the news and are trading for 12 cents
Imugene (IMU) has unveiled some positive data from its ongoing phase two study of HER-Vaxx in advanced gastric cancer.
The study is being conducted at a number of sites within Eastern Europe and India. It aims to measure the efficacy, safety and immune response in 68 patients with metastatic gastric cancer over-expressing the HER-2 protein.
The study is randomised into two arms of patients receiving either HER-Vaxx and standard-of-care chemotherapy or standard-of-care chemotherapy alone. The primary endpoint is overall survival and secondary endpoint will be progression-free survival.
HER-Vaxx is a B-cell peptide cancer immunotherapy designed to treat tumours that. over-express the HER-2 receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.
The Independent Data Monitoring Committee (IDMC) reviewed the HER-Vaxx phase two interim analysis safety and efficacy data. Pleasingly, the IDMC didn’t report any safety concerns and considers the preliminary data to be a strong indicator of a HER-Vaxx survival effect.
Interim analysis shows an overall survival hazard ratio (HR) of 0.418 (equating to an 80 per cent two-sided confidence interval ranging between 0.186 and 0.942). Additionally, the immunotherapy drug showed a reduced risk of death of 58.2 per cent in the HER-Vaxx plus chemotherapy group compared to the group undergoing chemotherapy alone.
Positively, the IDMC confirmed a favourable survival outcome with no added toxicity for HER-Vaxx combined with standard-of-care chemotherapy over
chemotherapy alone.
“I am delighted to report that we have achieved this significant milestone for patients with advanced gastric cancer. I am excited that the interim analysis favoured the survival outcome for HER-Vaxx and the IDMC suggested to shorten the study by lowering the number of patients,” Managing Director and CEO Leslie Chong said.
Given the strong signals observed in the data, the IDMC suggests Imugene reduce the overall number of patients required to complete the study.
Company shares are up a healthy 20 per cent following the news and are trading for 12 cents at 10:23 am AEDT.