While ESMO 2023 is just about to begin, potential pharma players such as Eli Lilly, AstraZeneca, and Novartis, Olema Oncology, Kelun-Biotech, and others are set for presenting their Breast Cancer abstracts under oral and posters presentations session type. Breast Cancer is one of the most malignant forms of cancer affecting a large segment of the population in the US with a total incident cases of ~287,000 in 2022. This content provides a brief summary of Lilly’s already approved CDK4/6 inhibitor VERZENIO’s  interim analysis on overall survival from monarchE study and upcoming next generation SERD, Imlunestrant from Phase Ia/b EMBER trial.

Unveiling the Latest in Breast Cancer Advancements

Eli Lilly set to reveal 5-year overall survival data from monarchE Phase III trial for VERZENIO in HR-positive, HER2-negative, high-risk early breast cancer, combined with endocrine therapy. A crucial update on breast cancer treatment.

• Abstract Number – # LBA17
• Abstract Type - Proffered Paper Session
• Indication - HR+/HER2–, high-risk early breast cancer
• Target – CDK4/6 inhibitor

For patients with high-risk early breast cancer, VERZENIO's groundbreaking monarchE study is a game-changer. VERZENIO significantly decreased the risk of disease recurrence or mortality in high-risk patients by an astounding 25.3%, according to research presented at the 2022 San Antonio Breast Cancer Symposium. These findings highlight VERZENIO's superiority as a CDK4/6 inhibitor, with the monarchE trial being specially created to examine its continued efficacy in high-risk early breast cancer after the initial two-year course of therapy. There were fewer deaths in the VERZENIO-plus-ET group than in the ET alone group, even the data on overall survival was still in its infancy. A monarchE Phase III interim analysis will support the use of abemaciclib in combination with adjuvant endocrine therapy for high-risk, HR+/HER2-negative, node-positive breast cancer.

Lilly is set to unveil groundbreaking results in a late-breaking presentation! Get ready for a game-changing update on VERZENIO from the five-year analysis of the Phase III monarchE study. This trial investigates the impact of two years of VERZENIO treatment combined with endocrine therapy in high-risk early breast cancer patients.  Stay tuned for the latest findings, a pivotal milestone in adjuvant breast cancer trials. Also, discover how dose reductions affect treatment efficacy in a separate poster presentation.

NATALEE trial shows 90.4% Kisqali takers survived without recurrence at three years, competing with VERZENIO's monarchE results of 89.2%. If KISQALI gains approval in this setting, it will intensify the competition.

 

Lilly will present clinical data on imlunestrant as a single agent and in combination therapy from the Phase I EMBER study in patients with ER+/HER2- advanced breast cancer.

• Abstract Number - #383MO
• Abstract Type - Mini oral session
• Indication - ER+/HER2- advanced breast cancer (aBC)
• Target - Selective Estrogen Receptor Degrader (SERD)

Imlunestrant (LY3484356) is a game-changing, next-generation oral SERD with potent anti-estrogen capabilities, set to revolutionize the treatment for ER+/HER2- breast cancer. This novel ER degrader promises to break through endocrine therapy resistance, offering the advantage of seamless oral delivery and unwavering receptor inhibition, regardless of ESR1 mutations. It is the key to consistent, convenient, and effective breast cancer treatment. 

In a mini oral presentation, Lilly will present clinical findings on imlunestrant as a standalone treatment and in combination with everolimus or alpelisib, unveiling groundbreaking results in the Phase I EMBER study for ER+/HER2- advanced breast cancer patients.

In the battle against drug resistance in ER-positive breast cancers, a new wave of game-changing molecules is emerging. Meet the cutting-edge selective estrogen receptor degraders (SERDs) - these innovative therapies, like SERMs, block estrogen binding to receptors. The buzz in the field revolves around combining SERMs and SERDs with pathway inhibitors affecting ESR1 signaling, with some oral SERDs showing remarkable potency. AstraZeneca's FASLODEX blazed the trail as the first FDA-approved SERD back in 2002. Now, Lilly's imlunestrant is in the pipeline, aiming to combat  advanced and metastatic breast cancer. In the EMBER Phase Ib trial, imlunestrant has shown impressive response rates, creating a buzz with a 36% ORR in combination with abemaciclib and a staggering 44% ORR when combined with both abemaciclib and AI. But the competition is fierce, with generic forms of FASLODEX already in the arena, challenging these newcomers in the battle against locally advanced and metastatic breast cancer.