Healthcare giant Eli Lilly’s Phase III EMBER-3 study in patients with advanced breast cancer showed imlunestrant, cut the risk of disease progression or death by 38% – but only a subset of patients benefitted.
In the Phase III trial, (NCT04975308) imlunestrant, an oral selective estrogen receptor degrader (SERD), significantly improved progression free survival (PFS) versus standard of care (SOC) in patients with an ESR1 mutation, at 5.5 months with imlunestrant compared to 3.8 months with SOC. The overall response rate (ORR) with imlunestrant was 14% compared to 8% with SOC in patients with an ESR1 mutation.
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The trial did not however meet statistical significance across all patients, with a median PFS of 5.6 months with imlunestrant versus 5.5 months with SOC.
The trial enrolled breast cancer patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) cancer, whose disease progressed on a prior aromatase inhibitor.
When used in combination with Verzenio (abemaciclib), the drug reduced the risk of progression or death by 43% versus imlunestrant alone in all patients.
Published in the New England Journal of Medicine the study saw patients randomised to receive imlunestrant alone, SOC endocrine therapy (either exemestane or fulvestrant) or imlunestrant in combination with Verzenio. The results were also unveiled at the San Antonio Breast Cancer Symposium (SABCS) on 11 December.
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By GlobalDataDavid Hyman, chief medical officer at Eli Lilly, said: “We’re highly encouraged by these data for both imlunestrant as monotherapy and in combination with Verzenio, as well as the safety and tolerability profile, which demonstrate the potential for imlunestrant to be a meaningful new oral endocrine therapy option for patients. We look forward to sharing these results with the oncology community and completing regulatory submissions to global health authorities.”
According to the company, approximately 70 to 80% of hormone receptor-positive breast cancers are ER+ and are typically addressed with injection administered fulvestrant. Results in the EMBER-3 study saw 72% of patients receiving fulvestrant complaining of site pain, swelling, or redness. Imlunestrant gets around this by being orally administered.
Komal Jhaveri, head of endocrine therapy research and clinical director at Memorial Sloan Kettering Cancer Center, said: “The median progression-free survival observed in EMBER-3 is among the most compelling we’ve seen in CDK4/6 pre-treated ER+, HER2- advanced breast cancer patients and indicates a potential shift in the therapy options we provide for these patients, which are currently very limited.
“The benefit and safety profile of the imlunestrant and Verzenio combination signal a potential new all-oral option for patients.” Elsewhere in the field of cancer treatment, a new combination therapy from the Roswell Park Comprehensive Cancer Center saw five of the nine triple-negative breast cancer patients enrolled in
