Indianapolis, U.S. – November 26, 2025 — Eli Lilly and Company — hereafter referenced as Lilly — today announced that it will present new data across its hormone receptor-positive (HR+), HER2-negative (HER2–) breast cancer programs at the upcoming San Antonio Breast Cancer Symposium (SABCS) 2025. The updates cover both early and advanced disease settings, reflecting Lilly’s ongoing momentum in oncology innovation. PR Newswire+2Investing.com India+2
Key Program Highlights from Lilly’s Breast Oncology Portfolio
Lilly’s SABCS 2025 presentations will feature data from multiple critical trials and programs, including:
- Inluriyo (imlunestrant) — In a late-breaking oral presentation, Lilly will share updated results from the Phase 3 EMBER-3 trial, evaluating Inluriyo alone and in combination with Verzenio (abemaciclib) in ER+, HER2– metastatic breast cancer. The update covers interim overall survival (OS) data along with progression-free survival (PFS) and time-to-chemotherapy (TTC) metrics. The presentation will also include exploratory analyses of ctDNA (circulating tumour DNA) dynamics and their correlation with clinical outcomes. Nasdaq+1
- LY4064809 / PIKALO‑1 trial (PI3Kα inhibitor) — Updated safety and efficacy data from this Phase 1/2 study will be shared, ahead of planned progression into Phase 3 (PIKALO-2). This could represent a novel option targeting PIK3CA-mutant HR+, HER2– advanced breast cancer. PR Newswire+1
- monarchE trial (Verzenio + endocrine therapy) — A subgroup analysis will be presented, exploring outcomes based on nodal status in high-risk early breast cancer patients receiving adjuvant therapy. Results will add granularity to existing data that have already shown long-term invasive disease–free survival (IDFS) and distant relapse-free survival (DRFS) benefits. Nasdaq+1
In a statement, Jacob Van Naarden, EVP & President of Lilly Oncology, said:
“At SABCS 2025, we are proud to showcase new data across our portfolio of investigational and approved therapies — targeting the three foundational biology axes in HR+ breast cancer: CDK4/6, estrogen receptor, and PI3K.” PR Newswire
Why This Matters — Impact of Lilly’s Progress
The upcoming data release from Lilly is strategically significant for multiple reasons:
• Addressing High-Need Patient Segments
HR+, HER2– breast cancer remains the most common subtype globally. With advances in oral SERD therapy (Inluriyo), targeted PI3Kα inhibitors (LY4064809) and refined adjuvant strategies (Verzenio), Lilly is expanding therapeutic options for both early-stage and advanced disease — a critical need given varying patient responses and mutation profiles.
• Strengthening Long-Term Treatment Pipeline
By combining established therapies with next-gen candidates, Lilly is creating a diversified oncology portfolio that spans endocrine therapy, targeted inhibitors, and combination regimens. This breadth helps mitigate risk and supports long-term innovation.
• Reinforcing Regulatory & Clinical Relevance
Late-breaking oral presentations, especially with updated OS and ctDNA data, boost confidence among clinicians, payors, and regulators. This can accelerate adoption, reimbursements, and potentially broaden indication pathways.
• Market Positioning & Investment Implications
For investors and stakeholders, Lilly’s deepening oncology portfolio enhances its long-term value proposition. As a company with diversified assets — from metabolic/GLP-1 drugs to oncology — stable innovation in cancer therapeutics strengthens its resilience amid shifting market trends. Wikipedia+1
What to Watch — Key Expectations & Milestones
As the industry prepares for SABCS 2025 (December 9–12, San Antonio), the following developments warrant close attention:
- Full EMBER-3 Data Release — Including OS curves, PFS benefit, safety data and ctDNA biomarker correlations, to assess how Inluriyo + Verzenio stacks up against existing therapies.
- PIKALO-1 to PIKALO-2 Transition — If Phase 1/2 data are robust, Lilly may fast-track the Phase 3 trial, impacting workflows for PIK3CA-mutant advanced breast cancer treatment.
- Subgroup Data from monarchE Trial — Nodal-status specific outcomes may refine patient selection and risk-stratification in adjuvant therapy, potentially influencing guideline updates.
- Regulatory & Market Reactions — Approval timelines, reimbursement decisions, and real-world adoption rates will shape Lilly’s commercial trajectory in oncology.
- Synergies Across Portfolio — Given Lilly’s broad pipeline (metabolic, oncology, cardio-metabolic), outcomes here may influence cross-indication strategies, company valuation, and R&D prioritization.
About Lilly
Lilly is a global pharmaceutical and biotechnology leader, with a broad portfolio spanning metabolic diseases, diabetes, oncology, immunology and neuroscience. Known for its commitment to innovation, Lilly continues to invest heavily in research and development — targeting high-unmet-need therapeutic areas such as HR+ breast cancer, immuno-oncology, and precision medicine. The company’s diversification and robust pipeline underpin its strong market positioning and investor appeal. Wikipedia+1
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