INDIANAPOLIS, May 22, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that data from studies of imlunestrant, an investigational oral selective estrogen receptor degrader (SERD), olomorasib, an investigational KRAS G12C inhibitor, LY4170156, an investigational antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) and Verzenio® (abemaciclib; a CDK4/6 inhibitor) will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 – June 3 in Chicago.
Presentation HighlightsImlunestrant (investigational oral SERD)
In an oral presentation, Lilly will share patient-reported outcomes (PROs) from the Phase 3 EMBER-3 trial in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC), and a poster presentation will feature expanded EMBER-3 safety analyses.
Olomorasib (investigational KRAS G12C inhibitor):In two oral presentations, Lilly will report updated results from a Phase 1/2 study of olomorasib, a potent and highly selective second-generation inhibitor of KRAS G12C with preliminary evidence of CNS activity, in combination with pembrolizumab in patients with KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC) and in combination with cetuximab in patients with KRAS G12C-mutant colorectal cancer (CRC). The submitted abstracts utilized a November 13, 2024 data cut-off date, and the presentations will utilize a January 15, 2025 data cut-off date.
LY4170156 (investigational ADC targeting FRα): In a poster presentation, Lilly will report initial results from the multicenter, open-label, first-in-human Phase 1a/1b study of LY4170156 in patients with platinum-resistant ovarian cancer (PROC). LY4170156 is an Fc-silent, FRα specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker. The submitted abstract utilized a November 27, 2024 data cut-off date, and the poster will utilize a March 9, 2025 data cut-off date.
A full list of abstract titles and viewing details are listed below:
Imlunestrant (investigational oral SERD):Presentation Title: Patient-reported outcomes (PROs) in patients with ER+, HER2- advanced breast cancer (ABC) treated with imlunestrant, investigator’s choice standard endocrine therapy, or imlunestrant + abemaciclib: Results from the phase III EMBER-3 trial
Abstract Number: 1001
Session Date & Time: Saturday, May 31, 1:15-4:15 p.m. CDT
Session Title: Breast Cancer – Metastatic
Location: Hall B1 | Live Stream
Presenter: Giuseppe Curigliano
Presentation Title: Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Safety analyses from the phase III EMBER-3 trial
Abstract Number: 1060
Session Date & Time: Monday, June 2, 9 a.m.-12 p.m. CDT
Session Title: Breast Cancer – Metastatic
Location: Hall A – Posters and Exhibits | On Demand
Presenter: Joyce O’Shaughnessy
Olomorasib (investigational KRAS G12C inhibitor):Presentation Title: Efficacy and safety of olomorasib, a second-generation KRAS G12C inhibitor, plus cetuximab in KRAS G12C-mutant advanced colorectal cancer
Abstract Number: 3507
Session Date & Time: Friday, May 30, 2:45-5:45 p.m. CDT
Session Title: Gastrointestinal Cancer – Colorectal and Anal
Location: Arie Crown Theater | Live Stream
Presenter: Antoine Hollebecque
Presentation Title: Safety and efficacy of olomorasib + immunotherapy in first-line treatment of patients with KRAS G12C-mutant advanced NSCLC: Update from the LOXO-RAS-20001 trial
Abstract Number: 8519
Session Date & Time: Monday, June 2, 8-9:40 a.m. CDT
Session Title: Lung Cancer – Non-Small Cell Metastatic
Location: Arie Crown Theater | Live Stream
Presenter: Alexander I. Spira
LY4170156 (investigational ADC targeting FRα):Presentation Title: Initial results from a first-in-human phase 1 study of LY4170156, an ADC targeting folate receptor alpha (FRα), in advanced ovarian cancer and other solid tumors
Abstract Number: 3023
Session Date & Time: Monday, June 2, 1:30-4:30 p.m. CDT
Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Location: Hall A – Posters and Exhibits | On Demand
Presenter: Isabelle Ray-Coquard
Verzenio (abemaciclib):Presentation Title: Impact of body mass index (BMI) on efficacy and safety of abemaciclib in breast cancer patients (pts) treated in the monarchE trial
Abstract Number: 520
Session Date & Time: Monday, June 2, 9 a.m.-12 p.m. CDT
Session Title: Breast Cancer – Local/Regional/Adjuvant
Location: Hall A – Posters and Exhibits | On Demand
Presenter: Christine Desmedt
For more information on Lilly’s Oncology pipeline click here.
About Imlunestrant
Imlunestrant is an investigational, brain-penetrant, oral selective estrogen receptor degrader (SERD), that delivers continuous ER inhibition, including in ESR1-mutant cancers. The estrogen receptor (ER) is the key therapeutic target for patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Novel degraders of ER may overcome endocrine therapy resistance while providing consistent oral pharmacology and convenience of administration. Imlunestrant is currently being studied as a treatment for advanced breast cancer and as an adjuvant treatment in early breast cancer, including: NCT04975308, NCT05514054, NCT04188548, NCT05307705.
About Olomorasib
Olomorasib (LY3537982) is an investigational, oral, potent, and highly selective second-generation inhibitor of the KRAS G12C protein. KRAS is the most common oncogene across all tumor types, and KRAS G12C mutations occur in 13% of patients with non-small cell lung cancer (NSCLC), and 1-3% of patients with other solid tumors.1 Olomorasib is a highly potent covalent inhibitor with potential for greater than 90% target occupancy, which may allow for safer combinations with less toxicity.2
Olomorasib is currently being studied in KRAS G12C-mutated cancers in combination with pembrolizumab with or without chemotherapy for first-line treatment of advanced NSCLC, in combination with immunotherapy for the treatment of resected and unresectable NSCLC, and as monotherapy and in combinations in other advanced solid tumors, including: NCT06119581, NCT06890598, and NCT04956640.
About LY4170156 LY4170156 is an investigational, next-generation antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα). FRα is a cell-surface glycoprotein encoded by the gene FOLR1 that binds to the essential nutrients folic acid and reduced folates, bringing them into cells to facilitate cell division and growth.3,4 FRα is overexpressed in many solid tumors such as ovarian, non-small cell lung, and colorectal cancers.3,5,6
LY4170156 was designed to target FRα across expression levels with an improved therapeutic index. LY4170156 is composed of a Fc-silent, FRα specific humanized monoclonal antibody, linked to exatecan, a topoisomerase-I inhibitor, via a proprietary cleavable polysarcosine linker. LY4170156 is currently being studied in patients with ovarian cancer as well as other FRα-expressing solid tumors, NCT06400472.
About Verzenio (abemaciclib)
Verzenio (abemaciclib) is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic settings.
Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is currently authorized for use in more than 90 counties around the world. For full details on indicated uses of Verzenio in HR+, HER2- breast cancer, please see full Prescribing Information, available at www.Verzenio.com.
INDICATIONS FOR VERZENIO
VERZENIO is a kinase inhibitor indicated:
in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)
Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, diarrhea occurred in 81 to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8 to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of the first diarrhea event ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19 to 26% of patients with diarrhea required a Verzenio dose interruption and 13 to 23% required a dose reduction.
Instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.
Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio. Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days, and the median duration of Grade ≥3 neutropenia ranged from 11 to 16 days. Febrile neutropenia has been reported in