The approval was supported by data from the Phase 3 EMERALD trial in which Orserdu showed statistically significant progression-free survival (PFS) versus standard-of-care
A product shot of Orserdu. (Credit: Business Wire)
Menarini Group has secured approval from the European Commission (EC) for Orserdu (elacestrant), an oral endocrine therapy, to treat certain types of breast cancer.
EC has cleared Orserdu as a monotherapy to treat postmenopausal women, and men, with estrogen receptor (ER)‑positive, HER2-negative, locally advanced or metastatic breast cancer (mBC) with an activating ESR1 mutation who showed disease progression after at least one line of endocrine therapy including a CDK 4/6 inhibitor.
The approval was supported by data from the Phase 3 EMERALD trial that enrolled 478 patients.
According to the results, Orserdu showed statistically significant progression-free survival (PFS) versus standard-of-care (SOC), defined as the investigator’s choice of approved endocrine monotherapy.
The study’s primary endpoints were PFS in the overall patient population and in those with ESR1 mutations, Menarini Group said.
The oral endocrine therapy improved median PFS from 1.9 months on the SOC to 3.8 months in the group of patients whose tumours contained ESR1 mutations. It also reduced mortality or progression risk by 45% compared to the SOC.
Additionally, a post hoc subgroup analysis of the EMERALD PFS results demonstrated that the duration of prior CDK4/6i treatment was positively related to prolonged PFS on Orserdu but not with SOC.
The therapy also resulted in a median PFS of 8.6 months versus 1.9 months on SOC for patients with ESR1 mutations treated with CDK4/6i for at least 12 months before randomisation in a late-stage trial.
Menarini Group CEO Elcin Barker Ergun said: “We have long known that patients living with metastatic breast cancer need effective and tolerable options which treat their disease while enabling them to focus on the things that matter to them.
“We are proud of delivering a new breast cancer treatment that offers efficacy in a once-daily pill and represents the first innovation in endocrine therapy in nearly two decades; we are also incredibly grateful for the support of the oncology researchers and all the patients who participated in the clinical studies that made today’s achievement possible.”
Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, and its affiliates will commercialise the product within Europe.