“We are excited about the potential for elacestrant to be approved for treatment of patients with advanced or metastatic ER-positive/HER2-negative breast cancer, which constitutes about 70% of breast cancer and remains an area of significant unmet medical need,” Elcin Barker Egun, chief executive officer of The Menarini Group, stated in a press release. The median PFS with the SERD was 3.8 months vs 1.9 months with SOC. In this population, the hazard ratio for PFS was 0.55 (95% CI, 0.39-0.77 P =. The 12-month PFS rates in the investigative and control arms were 22.3% (95% CI, 15.2%-29.4%) and 9.4% (95% CI, 4.0%-14.8%), respectively.Īdditionally, 228 patients had detectable ESR1 mutations at baseline 115 of these patients received elacestrant, and 113 were given SOC.
2 The median progression-free survival (PFS) in the investigative arm was 2.8 months vs 1.9 months in the control arm. At a median follow-up of 15.5 months, the oral selective estrogen receptor degrader (SERD n = 239) was found to reduce the risk of disease progression by 30% compared with standard-of-care (SOC n = 238) treatment per blinded independent central review (BICR HR, 0.70 95% CI, 0.55-0.88 P =.
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The application is supported by data from the phase 3 EMERALD trial (NCT03778931). A new drug application has been submitted to the FDA seeking the approval of elacestrant in the treatment of patients with estrogen receptor (ER)–positive, HER2-negative, advanced or metastatic breast cancer.
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