The US Food and Drug Administration (FDA) has approved Eli Lilly’s Inluriyo (imlunestrant) to treat advanced or metastatic breast cancer, following positive phase 3 trial data.
Certain breast cancers develop ESR1 mutations, which cause oestrogen receptors to become overactive and drive tumour growth. Inluriyo is a once-daily oral oestrogen receptor antagonist that binds to, blocks and degrades these overactive receptors.
“This therapy represents an important step toward advancing innovative, all-oral treatment approaches,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology.
In the phase 3 EMBER-3 trial, Inluriyo reduced the risk of progression or death by 38% versus ET. Among patients with ESR1-mutated MBC, Inluriyo significantly improved progression-free survival (PFS) versus fulvestrant or exemestane, with a median PFS of 5.5 months vs 3.8 months.
Inluriyo is expected to be available in the US shortly. It is indicated for adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).
“This represents an important advancement for patients with ESR1-mutated MBC, a mutation found in nearly half of patients who have taken hormone therapies, often contributing to treatment resistance,” said Komal Jhaveri, section head of Endocrine Therapy Research and clinical director of Early Drug Development at Memorial Sloan Kettering Cancer Center, and a principal investigator of EMBER-3.
“With its demonstrated efficacy, tolerability profile and oral administration, this therapy provides a meaningful alternative treatment option for this patient population.”