This retrospective study which was presented by Uma Borate looked at our Beat AML dataset for all the treatment that patients received on Beat AML. This is an add-on to the study that we published in Nature Medicine from a data pool from the inception of the trial from November 2016 to three years later to 2019. In the initial data that we published we did see that it was safe for patients to wait seven days for their genomic screening before starting on treatment. The second thing that we saw was that when patients received a personalised treatment they did better than receiving standard of care.
A lot has changed in the treatment of AML since that study was published and most notably was the FDA approval of venetoclax and azacitidine with the VIALE-A data. So what we did is we went back to our Beat AML data and we looked at the real world data that we collect with patients who don’t enrol into a sub-study along with those who did enrol into a sub-study. So therefore we divided our patients into five groups – those who received intensive chemotherapy off study; those who received a non-intensive treatment off study; those who received venetoclax and HMA agent off study; those who received a sub-study with targeted and those with a non-intensive and then who received intensive treatment on a sub-study along with a targeted agent.
Basically what we saw was that people who received a non-intensive treatment off study had a median overall survival of 6 months. Those who received venetoclax azacitidine or venetoclax HMA off protocol had a median overall survival of 13.2 months which is a little less than the VIALE-A 14.7 months off study and we believe that this is attributed to just real world data collection of the patients who were treated in community sites and that’s what is being seen there. When compared to non-intensive sub-study treatment we see a median overall survival of 14 months, so not much different than the venetoclax and azacitidine overall survival of 13.2 months. Again, we did see higher median overall survival with those treated with intensive treatments, intensive chemotherapy, so those on sub-study had a median overall survival of 40 months compared to 42 months for those treated off study.
The overall results that we’re getting from this is that, yes, venetoclax and hypermethylating agents have increased the median overall survival compared to the non-intensive standard of care of an HMA, which is very comparable to targeted treatments. So we believe that this is a really good indication to continue to pursue these targeted treatments but to also combine those with venetoclax and azacitidine so we can increase that median overall survival.
So we’re looking forward to what’s going to happen in the upcoming years with AML treatment to see the combination of targeted treatments with venetoclax and HMAs to see if we can further increase overall survival for these AML patients who desperately need it.