Elacestrant improved progression-free survival in patients with ER-positive/HER2-negative advanced or metastatic breast cancer.
The novel drug elacestrant showed promising results in improving outcomes for patients with metastatic breast cancer, according to results from the phase 3 EMERALD clinical trial.
The trial had two goals: improved progression-free survival (compared to standard of care) in the overall study population of patients with ER-positive/HER2-negative advanced or metastatic breast cancer (466 patients), as well as those whose tumors harbor ESR1 mutations (220 patients). Both endpoints were met, which is particularly exciting since ESR1 mutations tend to drive resistance to endocrine therapy.
“Advanced /metastatic ER+/HER2- BC pre-treated with endocrine therapy remains an area of high unmet medical need. Additional therapeutic options for this patient population are urgently needed,” said Dr. Aditya Bardia, associate professor at the Medicine Department at Harvard Medical School, and Principal Investigator for the EMERALD trial, in a statement.
More detailed study results will be presented at the upcoming San Antonia Breast Cancer Symposium this December.
“The trial results being statistically significant demonstrate a clinically meaningful improvement of PFS in the elacestrant group versus endocrine standard of care in patients previously treated with endocrine therapies and CDK 4/6 inhibitors. The results provide a significant advancement for patients suffering from this devastating disease. It was also important to see the positive data for those patients with ESR1 mutations, known to confer additional resistance to standard endocrine therapy,” Bardia said.
Elacestrant is a selective estrogen receptor degrader (SERD), which is taken by mouth once a day. Prior studies showed that it could work as a single-agent or when combined with other treatments for patients with breast cancer.
“We are extremely excited as elacestrant is the first oral SERD to show positive topline results in a pivotal trial as a monotherapy vs SoC for the treatment of ER+HER2-advanced or mBC,” commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.
“The results pave the way towards our working with the regulators to bring elacestrant to patients with ER+/HER2- advanced or metastatic breast cancer, which remains a huge unmet medical need. Notably, the topline results were also positive for the ESR1 mutation sub segment, an important driver of resistance to endocrine therapy in ER+/HER2- mBC patients. We intend to share the data at the San Antonio Breast Cancer Symposium in December.”
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