Media Thread, page-5687

I have often wondered about the Overall Survival (OS) rate and the implications for the HERVaxx trial targeting HER-2 positive gastric cancer. Surely the trial just doesn’t keep meandering on for as long as a patient survives. There must be an endpoint – but I have been unable to access the trial structure.

Kluk has posted that we are still waiting for the HERVaxx OS data, because some of those terminally ill trial patients are still living since their first dosing on 31/7/2017. I have not verified this date but assume he is correct.

I did find an update dated 23/11/20 where IMU reported that Hervaxx showed OS in its Phase 2 trial.

They reported that interim analysis in the trial showed statistically significant overall survival Hazard Ratio (HR) of 0.418 and that HER-Vaxx showed a reduced risk of death of 58.2% in the HER-Vaxx plus chemotherapy group as compared to chemotherapy alone.

The median OS for patients receiving HER-Vaxx plus chemotherapy in that trial was reported as 14.2 months, compared to 8.8 months in patients treated with chemotherapy alone.
I have not been able to find any more recent update.
From the National Cancer Institute I found this definition of Overall Survival Rate.

It is stated to be: the percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.

My question is this. Can someone who is more knowledgeable and is aware of the initial trial set-up confirm or otherwise that the trial continues endlessly, or do we have in fact a five year endpoint for the trial. If the latter, then the 5 year period would be up end of July and IMU would soon be free to release the results.

Wouldn't that be wonderful!