This is the EMERALD trial which is a phase III clinical trial that looks at the oral SERD elacestrant, compared to standard of care endocrine therapy in patients with metastatic oestrogen receptor positive breast cancer.
On that clinical trial, which was presented at the San Antonio Breast Cancer Symposium in 2021, it showed that elacestrant improved outcomes, especially progression free survival, in patients with metastatic ER positive breast cancer compared to standard of care endocrine therapy which was either an aromatase inhibitor or fulvestrant.
On this paper we were looking at a subgroup of patients that did not receive chemotherapy. The inclusion criteria for elacestrant were either patients that had received one or two endocrine therapies in the metastatic setting, one had to be a CDK4/6 inhibitor, but patients that had received one prior chemotherapy were allowed to enrol on the trial. But the subset analysis that we presented today was not including the chemotherapy patients, it only included the patients that had received one or two prior endocrine therapies.
What we found was pretty similar results to what we found with the overall patient population that elacestrant improves progression free survival in either the intention to treat patient population or in patients with mutations in their ESR1.
The implication is, based especially on the overall results of the EMERALD trial, that elacestrant is superior as endocrine therapy in metastatic hormone receptor positive breast cancer. That superiority is not just in patients that receive an aromatase inhibitor but also fulvestrant, not just in patients that have received one prior chemotherapy regimen but also in patients that are chemo naïve.
So this is a registrational trial, we’re going to have the FDA look at elacestrant, hopefully, potentially approve it for use and then we’ll be able to use it in metastatic HR positive patients.