Eli Lilly's Investigational Cancer Drug Cuts Risk Of Death By 38% In Breast Cancer Patients

On Wednesday, Eli Lilly And Co LLY announced results from the Phase 3 EMBER-3 study of imlunestrant for estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative advanced breast cancer, whose disease progressed on a prior aromatase inhibitor, with or without a CDK4/6 inhibitor.

Imlunestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as monotherapy in patients with an ESR1 mutation versus standard of care endocrine therapy (SOC ET), reducing the risk of disease progression or death by 38%.

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Imlunestrant in combination with Eli Lilly’s Verzenio (abemaciclib) reduced the risk of progression or death by 43% versus imlunestrant alone, in all patients.

Imlunestrant significantly improved progression-free survival versus standard-of-care endocrine therapy in patients with an ESR1 mutation.

In patients with an ESR1 mutation, the median progression-free survival was 5.5 months with imlunestrant versus 3.8 months with standard-of-care endocrine therapy.

The overall response rate (ORR) with imlunestrant was 14% compared to 8% with SOC ET in patients with an ESR1 mutation.

In all patients, the median PFS was 5.6 months with imlunestrant versus 5.5 months with standard-of-care endocrine therapy and did not reach statistical significance.

Imlunestrant-abemaciclib significantly improved PFS compared to imlunestrant in all patients, regardless of ESR1 mutation status, with median PFS of 9.4 months for imlunestrant-abemaciclib versus 5.5 months for imlunestrant alone.

In all patients, the ORR with imlunestrant-abemaciclib was 27% compared to 12% with imlunestrant alone.

Overall survival (OS) results for EMBER-3 were immature at the time of analysis. The trial will continue to assess OS as a secondary endpoint.

Imlunestrant is also being investigated in the adjuvant setting in people with ER+, HER2- early breast cancer with an increased risk of recurrence. This Phase 3 trial EMBER-4 is expected to enroll 6,000 patients.

Price Action: LLY stock is down 1.20% at $790.01 at the last check on Wednesday.

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