Hi, I'm new to this thread so apologies if this information has already been posted.
I wanted to see what kind of response rates Herceptin + chemo generates to compare with the data we have to date from Her-vaxx. The following study completed in 2010 looks like a good comparison.
https://clinicaltrials.gov/ct2/show/study/NCT01041404I note that patients who had previously received chemo for metastatic disease were excluded whereas for the Her-vaxx 1b my understanding is only patients who had received chemo in the
past 6 months were excluded. I don't know if this would make a significant difference.
Anyway, ORR (CR+PR as percentage of participants for the Herceptin + chemo arm was 47.3% so this is seems somewhat similar to the data we have from Her-vaxx to date albeit from a much smaller sample (6/14 ORR or 43%).
A couple of other points.
1) The Herceptin trial data is more mature. We have already seen an improvement in the ORR data for the HER-vaxx 1b between December and February and this may continue.
2) The patients in HER-vaxx 1b received different doses and only one group of three received the optimum dose whereas all 294 patients in the Herceptin arm of that trial received the optimum dose. Ie it is possible that a 50 microgram dose is significantly more efficacious compared to 10/30 doses used in the 1b. Hence the blended result from the 1b may understate the potency of HER-vaxx.
3) We are hoping that the cancer will prove to be less resistant to the polyclonal antibodies stimulated by HER-vaxx compared to Herceptin which is a reason to think that the 1b data will continue to improve as it matures.
4) A sample size of 14 is far too small to compare ORR and OS is what counts anyway. All we really know at this stage is that HER-vaxx works to some extent and keeps working over time (at least the first 98 days).
5) I assume the updated 1b data in the latest investor presentation is the position 98 days after the final patient started treatment ie the 98 day follow up (the 17/12/18 announcement being the position at 56 days). Perhaps we should expect the next update to be after another 84 days ie end of May.
https://static1.squarespace.com/static/5b63d41b3e2d09b1f56bf483/t/5c4866274fa51a8e6eba4fa1/1548248617026/Imugene_ASCO_GI.pdf
(20min delay)
