Paolo Tarantino, MD, PhD, discusses the approval of the oral therapy elacestrant for patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer with ESR1 mutations.
Paolo Tarantino, MD, PhD, medical oncologist and clinical fellow at Dana-Farber Cancer Institute, discusses the approval of the oral therapy elacestrant (Orserdu) for patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer with ESR1 mutations.
Based on the phase 3 EMERALD trial (NCT03778931), the FDA approved elacestrant for these patients who had previously received standard therapies, including at least 1 line of endocrine therapy. In the trial, patients had gone through lines of treatment with endocrine therapy and CDK4/6 inhibitors, with some also receiving chemotherapy or fulvestrant.
The study showed that the oral selective estrogen receptor degrader (SERD) provided a significant improvement in progression-free survival compared with standard-of-care (SOC) treatment in patients with ESR1 mutations and those who had previously used CDK4/6 inhibitors for at least a year. These patients, who have endocrine-sensitive disease, are good candidates for elacestrant, which is well-tolerated, according to Tarantino.
TRANSCRIPTION:
0:10 | The first oral SERD that has been approved has been approved based on the phase 3 EMERALD trial that was a study that enrolled patients with hormone receptor–positive metastatic breast cancer who had been previously treated with standard-of-care treatments. They had to have received endocrine treatment; 100% of the patients received prior CDK4/6 inhibitors, and some of the patients, a small subset, had also received chemotherapy or fulvestrant previously—that is an injectable SERD. Patients were [randomly assigned] to receive either the oral SERD elacestrant or standard-of-care endocrine treatment, which could be an aromatase inhibitor or fulvestrant.
0:51 | The study was positive, and it showed that there was a significant improvement in progression-free survival with elacestrant over standard-of-care endocrine treatment. This was particularly noted in certain subpopulations in the study, and in particular among patients with ESR1 mutations. They were about 40% of the patients in the trial, and in particular the outcomes were best among those patients that had received prior CDK4/6 inhibitors for at least 1 year before being enrolled on the trial, basically expressing the fact that those patients who have more endocrine-sensitive disease, more luminal disease, who derive benefit from prior CDK4/6 inhibitors and have ESR1 mutations are great candidates for trying elacestrant as a treatment, which is very well tolerated, and is currently FDA approved for this indication.
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