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SABCS 2022 | Updated results by duration of prior CDK4/6i in the met setting of the Phase III EMERALD trial

Aditya Bardia, MD, Massachusetts General Hospital, Boston, MA, provides an overview of the updated results from the EMERALD study (NCT03778931). Updated safety data were consistent with previously reported results and updated progression-free survival results show statistically significant results in favor of elacestrant, both in all patients and in patients with an ESR1 mutation, highlighting its potential role as a therapeutic option for patients with ER+/HER2- metastatic breast cancer. This interview took place at the San Antonio Breast Cancer Symposium (SABCS) 2022 in San Antonio, TX.

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Transcript (edited for clarity)

At SABCS 2022, we see the updated results from the EMERALD trial. As a brief background at SABCS 2021, we saw the first results from the EMERALD trial, which looked at elacestrant was a standard endocrine therapy in the second-line plus setting for patients with metastatic hormone receptor-positive breast cancer. In this setting, we tend to use fulvestrant as the endocrine therapy, but fulvestrant is given as an intramuscular shot and the median PFS is around two months, So it’s not great with standard fulvestrant as a single agent...

At SABCS 2022, we see the updated results from the EMERALD trial. As a brief background at SABCS 2021, we saw the first results from the EMERALD trial, which looked at elacestrant was a standard endocrine therapy in the second-line plus setting for patients with metastatic hormone receptor-positive breast cancer. In this setting, we tend to use fulvestrant as the endocrine therapy, but fulvestrant is given as an intramuscular shot and the median PFS is around two months, So it’s not great with standard fulvestrant as a single agent. So clinically there’s an unmet need for better therapies.

In the EMERALD trial, we saw that elacestrant was superior to standard endocrine therapy, including fulvestrant in the second-, third-line setting for patients with metastatic hormone receptor-positive breast cancer. So that was presented at SABCS 2021 and SABCS 2022. We see updated results in part because if you look at the PFS curves, we see that there was an initial drop in both arms and then separation. The initial drop was likely because of endocrine-resistant disease and separation was seen in the endocrine-sensitive disease. So the question was can we identify a surrogate biomarker that could predict endocrine-sensitive disease? We looked at prior duration of CDK4/6 inhibitor, and we found that the duration of prior CDK4/6 inhibitor predicted for duration of benefit with elacestrant.

So for example, patients who had been on a prior CDK4/6 inhibitor for 12 months or more, the median progression-free survival with elacestrant was more than eight months as compared to two months with fulvestrant. So you could clearly see benefit with elacestrant versus standard endocrine therapy in this subgroup. Results that were clinically meaningful and statistically significant as well, particularly ESR1 mutant metastatic breast cancer. So it provides us a surrogate biomarker that predicts for endocrine-sensitive disease and can identify patients who do well with endocrine monotherapy such as elacestrant.

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