Our research is focussed on endometrial cancer which, unfortunately, is one of the few cancers that is actually increasing in incidence and increasing in death rate here in the United States. It’s also a cancer where we have one of the largest racial disparities in outcome with our Black patients really suffering twice the death rate of other patients.
Our study is the RUBY study which is a phase III blinded multicentre randomised trial of dostarlimab with carboplatin paclitaxel versus placebo and carboplatin paclitaxel in women who have suffered either advanced stage or recurrence of their endometrial cancer.
The results of the study and what we are presenting here at ASCO had to do with additional endpoints of the study. The overall highlighted results of the study were recently published in The New England Journal of Medicine showing a dramatic improvement in progression free survival for patients enrolled in the study. To highlight some of the aspects of that there was a 71% reduction in progression or death in those patients with defective mismatch repair cancers. Then the overall population of study also showed statistically significant improvements as well as a very strong trend towards overall survival benefit with the addition of dostarlimab to carboplatin and paclitaxel.
Our research was specifically looking at the BICR assessment, so the blinded independent central review, and how that compared to our investigator assessment. There was good concordance with that which gives us reason to believe that there wasn’t undue bias in this study and also important for our regulatory agencies. This is very important as we look to have these therapies approved by the regulatory agencies, namely the FDA. These findings have led to NCCN guidelines being changed to allow the addition of dostarlimab to be added to carboplatin paclitaxel for these patients. So we have changed the standard of care and really now are looking to the FDA for formal approval which hopefully will happen in the near future.