Eli Lilly LLY announced results from the phase III EMBER-3 study, which showed that treatment with its orally administered investigational drug imlunestrant significantly reduced the risk of disease progression or death in certain patients with advanced breast cancer (ABC).

The EMBER-3 study enrolled patients with estrogen receptor (ER)-positive, HER2-negative ABC whose disease progressed during or following an aromatase inhibitor (AI) therapy, with or without a CDK 4/6 inhibitor. These patients were then randomized into three equal groups to receive imlunestrant monotherapy, a combination of imlunestrant and Lilly’s blockbuster breast cancer drug Verzenio (abemaciclib) or standard of care (SoC) endocrine therapy (ET).

More on LLY’s EMBER-3 Study Results

Treatment with imlunestrant monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) compared to SOC ET in patients with ESR1 mutations. Data from the study showed that the drug significantly reduced the risk of progression or death by 38% compared to those who received SOC ET in patients with ESR1 mutations.

However, imlunestrant alone did not show a statistically significant PFS benefit in the larger group that included all patients who had received the drug regardless of ESR1 mutations when compared to SoC ET.

Treatment with the imlunestrant-Verzenio combination also demonstrated a statistically significant and clinically meaningful improvement in PFS in all patients compared to imlunestrant monotherapy. Data from the study showed that the combination significantly reduced the risk of progression or death by 43% compared to those who received imlunestrant alone.

Per Lilly, the above results demonstrate imlunestrant’s potential as a new oral endocrine therapy option for patients. Management continues to assess the secondary endpoint of overall survival (OS), which at the time of the above analysis is yet to mature.

LLY Stock Performance

Year to date, Eli Lilly’s shares have surged 36.6% compared with the industry’s 7.7% rise.

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Verzenio — A Key Top-line Driver for LLY

An orally administered CDK4/6 inhibitor, Verzenio is approved in more than 90 countries, including the United States and the European Union (marketed as Verzenios), for use in certain patients with HR-positive, HER2-negative breast cancers in the adjuvant and advanced or metastatic setting.

In the first nine months of 2024, the drug added sales worth $3.8 billion to Lilly’s top line, up 38% year over year. Sales of this drug have been rising, driven by strong demand in the early breast cancer (EBC) indication.

Other Therapies Rivalling LLY’s Imlunestrant

Imlunestrant is a brain-penetrant selective estrogen receptor degrader (SERD) that offers continuous ER inhibition, including in ESR1-mutant cancers.

If approved, the drug will face stiff competition from Orserdu, which was approved by the FDA last year as the first orally administered SERD. The drug is marketed by Italy-based Menarini Group.

AstraZeneca AZN is also developing its oral SERD drug, camizestrant, in multiple late-stage studies as both monotherapy and combination with CDK4/6 inhibitors across different breast cancer settings. AZN also markets Faslodex, a SERD drug that is approved for administration via an injection.

We remind investors that Lilly’s Verzenio is approved in combination with AstraZeneca’s Faslodex to treat certain patients with advanced/metastatic breast cancer.

LLY Partners With Ro to Expand Obesity Drug Access

In a separate press release, telehealth firm Ro announced that it will offer single-dose vials of Eli Lilly's popular obesity drug Zepbound on its platform. This makes it the first alternative platform to offer the lower-cost version outside Lilly's direct-to-consumer website, LillyDirect.

The vials will be offered as a treatment option with an on-label prescription from a Ro-affiliated provider through an integration with the LillyDirect’s self-pay pharmacy channel.

Lilly’s intent behind this launch seems clear – to ensure a ‘broader availability’ of Zepbound. The single-dose vials of the drug were launched by the company in August to meet the high demand for the drug. These vials are sold without an autoinjector, making it easier and less time-consuming to manufacture them and improve supply. Patients will require a syringe to inject themselves.

Ro also offers to fill prescriptions for Novo Nordisk’s NVO Wegovy, a rival to Lilly’s Zepbound.

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LLY’s Zacks Rank

Eli Lilly currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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