- Imugene (IMU) reports positive and “favourable” survival outcome in final data from its randomised phase two study of HER-Vaxx in advanced gastric cancer
- The final analysis reflects a reduced risk of death in 41.5 per cent of patients treated with HER-Vaxx plus standard-of-care chemotherapy compared to SOC chemotherapy alone
- Further, the median overall survival for patients receiving the combined treatment was 13.9 months, compared to 8.3 months in patients treated with chemotherapy alone
- The company also confirms the HERIZON-extension Cohort Review Committee (CRC) has approved the use of a new higher dose of HER-Vaxx at 100 micrograms in the next HERIZON and neoHERIZON studies commencing soon
- Shares in Imugene are trading 12.1 per cent higher at 18.5 cents at 10:39 am AEST
Imugene (IMU) has reported positive final overall data from its phase two study of HER-Vaxx in Her-2/Neu overexpressing advanced gastric cancer.
The final analysis results showed a statistically significant overall survival Hazard Ratio (HR) of 0.585 which reflects a reduced risk of death in 41.5 per cent of patients treated with HER-Vaxx plus standard-of-care (SOC) chemotherapy compared to SOC chemotherapy alone.
Further, the median overall survival (OS) for patients receiving the combined treatment was 13.9 months, compared to 8.3 months in patients treated with chemotherapy alone.
The company also noted that the HER-Vaxx treatment group generated the strongest anti-Her-2 antibody levels from their dosing schedule.
Managing Director and CEO Mrs Leslie Chong called the results a “significant milestone” for patients with advanced gastric cancer.
“The final analysis favoured the survival outcome for HER-Vaxx and I note the Independent Data Monitoring Committee previously suggested to shorten the study by lowering the number of patients.”
Additionally, the company has also confirmed the HERIZON-extension Cohort Review Committee (CRC) has approved the use of a new higher dose of HER-Vaxx at 100 micrograms in the next HERIZON and neoHERIZON studies commencing soon.
The higher dose is expected to accelerate and strengthen antibody generation to further improve the clinical response for HER-Vaxx.
The company has completed and delivered a large-scale batch of HER-Vaxx for use in all planned clinical trials.
“Reliability of drug supply is a major hurdle for clinical development of many modern biological oncology drug candidates,” Mrs Chong said.
“De-risking this critical component of clinical development is a significant achievement for Imugen.”
The phase two HER-Vaxx study was designed to measure the efficacy, safety and immune response in patients with metastatic gastric cancer overexpressing the HER-2 protein.
The study was randomised into two arms of either HER-Vaxx plus SOC chemotherapy or SOC chemotherapy alone. The primary endpoint was overall survival and secondary endpoint was progression-free survival. Safety, tolerability and immune response was also measured.
Shares in Imugene were trading 12.1 per cent higher at 18.5 cents at 10:39 am AEST.