Eli Lilly has announced new study data on Inluriyo (imlunestrant) as a treatment for patients with ER+, HER2– metastatic breast cancer.
It applies specifically to advanced or metastatic breast cancer that is oestrogen receptor positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), where the disease has progressed on a prior aromatase inhibitor (AI), with or without a cyclin-dependent kinase 4/6 inhibitor.
Follow-up results from the phase 3 EMBER-3 study showed that, as a monotherapy, Inluriyo demonstrated a 38% reduction in the risk of progression or death, as well as an 11.4-month improvement in median overall survival (OS), versus endocrine therapy in patients with oestrogen receptor 1-mutated disease.
Additionally, across all patients, Inluriyo plus abemaciclib reduced the risk of progression or death by 41% versus Inluriyo alone. This combination demonstrated a favourable OS trend, and delayed time to chemotherapy by over a year.
Data regarding the Inluriyo plus abemaciclib combination was consistent with previous efficacy results. The safety profile of Inluriyo-based regimens was also consistent with previous reports, and no new safety signals were observed.
“With an additional year of follow-up, these results strengthen the case for imlunestrant-based regimens in ER+, HER2– metastatic breast cancer,” said Dr Komal Jhaveri, associate attending Breast Medicine and Early Drug Development Services, section head of Endocrine Therapy Research Program at Memorial Sloan Kettering Cancer Center, and one of the study’s principal investigators. “The median progression-free survival of 11 months is among the longest we’ve seen in this population, and just as importantly, patients are living longer without needing chemotherapy.”
Metastatic breast cancer occurs when the cancer spreads to other parts of the body. In the US, around 30% of all high risk early-stage breast cancer cases will become metastatic, and around 6-10% of newly diagnosed breast cancer cases are already metastatic. The five-year survival rate for metastatic/advanced breast cancer is 30%.
Jacob Van Naarden, executive vice president and president of Lilly Oncology, said: “Following the recent FDA approval of Inluriyo as monotherapy, this updated data demonstrates continued clinically meaningful benefit – both for patients receiving monotherapy and those receiving the combination with abemaciclib – and further reinforces its role in this treatment setting.”