INDIANAPOLIS, May 23, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from studies of Verzenio® (abemaciclib; a CDK4/6 inhibitor), Retevmo® (selpercatinib; a rearranged during transfection [RET] inhibitor), olomorasib (an investigational KRAS G12C inhibitor) and imlunestrant (an investigational oral selective estrogen receptor degrader [SERD]) will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4 in Chicago.

Lilly will also host an investor event to provide an update on its oncology strategy and pipeline. The event will take place on Sunday, June 2, at 7:30 p.m. CDT and will be available via a live webcast on the "Webcasts & Presentations" section of Lilly's investor website. A replay will also be available on the website following the event.

Presentation Highlights

Verzenio (abemaciclib)In a late-breaking oral presentation, Lilly will report outcome data from the pivotal Phase 3 postMONARCH study evaluating Verzenio in combination with fulvestrant compared to placebo plus fulvestrant for patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with disease recurrence or progression on a prior CDK4/6i plus endocrine therapy.

Retevmo (selpercatinib)In a rapid oral abstract presentation, Lilly will report results from the Phase 1/2 LIBRETTO-121 study evaluating the safety and efficacy of Retevmo in pediatric and adolescent patients with advanced solid tumors harboring an activating RET alteration.

Olomorasib (investigational KRAS G12C inhibitor):In two oral presentations, Lilly will report updated results from the Phase 1/2 study evaluating the safety and efficacy of olomorasib (LY3537982), a potent and highly selective second-generation inhibitor of KRAS G12C, in combination with pembrolizumab in patients with KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC), and updated results for olomorasib as a monotherapy in patients with KRAS G12C-mutant advanced solid tumors. Submitted abstracts utilized an October 30, 2023 data cut-off date, and the presentations will utilize a March 18, 2024 data cut-off date.

A full list of abstract titles and viewing details are listed below:

Verzenio (abemaciclib):Presentation Title: Abemaciclib plus fulvestrant vs fulvestrant alone for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy: Primary outcome of the phase 3 postMONARCH trialAbstract Number: LBA1001Presentation Date & Time: Saturday, June 1, 3:00 p.m. – 3:12 p.m. CDTLocation: Hall B1 (Live Stream)Presenter: Kevin Kalinsky

Presentation Title: CYCLONE 2: A phase 3 study of abemaciclib with abiraterone in patients with metastatic castration-resistant prostate cancerAbstract Number: 5001Presentation Date & Time: Saturday, June 1, 3:12 p.m. – 3:24 p.m. CDTLocation: Arie Crown Theater (Live Stream)Presenter: Matthew Smith

Presentation Title: Prognostic utility of ctDNA detection in the monarchE trial of adjuvant abemaciclib plus endocrine therapy (ET) in HR+, HER2-, node-positive, high-risk early breast cancer (EBC)Abstract Number: LBA507Presentation Date & Time: Monday, June 3, 5:12 p.m. – 5:24 p.m. CDTLocation: Hall B1 (Live Stream)Presenter: Sherene Loi

Retevmo (selpercatinib):Presentation Title: Safety and efficacy of selpercatinib in pediatric patients with RET-altered solid tumors: Updated results from LIBRETTO-121Abstract Number: 10022Presentation Date & Time: Sunday, June 2, 5:06 p.m. – 5:12 p.m. CDTLocation: S504 (On Demand)Presenter: Daniel Morgenstern

Presentation Title: Intracranial outcomes of 1L selpercatinib in advanced RET fusion-positive NSCLC: LIBRETTO-431 studyAbstract Number: 8547Presentation Date & Time: Monday, June 3, 1:30 p.m. – 4:30 p.m. CDTLocation: Hall A (On Demand)Presenter: Maurice Perol

Presentation Title: Selpercatinib in non-MTC, RET-mutated tumors: Efficacy in MEN-associated and other tumorsAbstract Number: 3150Presentation Date & Time:Saturday, June 1, 9:00 a.m. – 12:00 p.m. CDTLocation: Hall A (On Demand)Presenter: Philippe Cassier

Presentation Title: Health-related quality of life (HRQoL) and symptoms in LIBRETTO-431 patients with RET fusion-positive advanced non-small-cell lung cancer (NSCLC)Abstract Number: 11068Presentation Date & Time: Monday, June 3, 9:00 a.m. – 12:00 p.m. CDTLocation: Hall A (On Demand)Presenter: Caicun Zhou

Presentation Title: Comparative patient-reported tolerability (PRT): A multiplicity-controlled analysis of LIBRETTO-531, a randomized controlled trial (RCT) in medullary thyroid cancer (MTC)Abstract Number: 11111Presentation Date & Time: Monday, June 3, 9:00 a.m. – 12:00 p.m. CDTLocation: Hall A (On Demand)Presenter: Marcia Brose

Imlunestrant (investigational oral SERD):Presentation Title: Imlunestrant, an oral selective estrogen receptor degrader (SERD), in combination with human epidermal growth factor receptor 2 (HER2) directed therapy, with or without abemaciclib, in estrogen receptor (ER) positive, HER2 positive advanced breast cancer (aBC): EMBER phase 1a/1b studyAbstract Number: 1027Presentation Date & Time: Sunday, June 2, 9:00 a.m. – 12:00 p.m. CDTLocation: Hall A (on Demand)Presenter: Manali Bhave

Presentation Title: Imlunestrant, an oral selective estrogen receptor degrader (SERD), as monotherapy and in combination with abemaciclib, in endometrioid endometrial cancer (EEC): Results from the EMBER phase 1a/1b studyAbstract Number: 5589Presentation Date & Time: Monday, June 3, 9:00 a.m. – 12:00 p.m. CDTLocation: Hall A (on Demand)Presenter: Kan Yonemori

Olomorasib (investigational KRAS G12C inhibitor):Presentation Title: Efficacy and safety of olomorasib (LY3537982), a second-generation KRAS G12C inhibitor (G12Ci), in combination with pembrolizumab in patients with KRAS G12C-mutant advanced NSCLCAbstract Number: 8510Presentation Date & Time: Saturday, June 1, 1:39 p.m. – 1:51 p.m. CDTLocation: Hall B1 (Live Stream)Presenter: Timothy Burns

Presentation Title: Pan-tumor activity of olomorasib (LY3537982), a second-generation KRAS G12C inhibitor (G12Ci), in patients with KRAS G12C-mutant advanced solid tumorsAbstract Number: 3007Presentation Date & Time:Saturday, June 1, 5:00 p.m. – 5:12 p.m. CDTLocation: Hall D1 (Live Stream)Presenter: Rebecca Suk Heist

About Verzenio® (abemaciclib) Verzenio® (abemaciclib) is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic setting. Verzenio is the first and only CDK4/6 inhibitor approved to treat node-positive, high risk early breast cancer (EBC) patients. The National Comprehensive Cancer Network® (NCCN®) recommends consideration of two years of abemaciclib (Verzenio) added to endocrine therapy as a Category 1 treatment option in the adjuvant setting.1 NCCN® also includes Verzenio plus endocrine therapy as a preferred treatment option for metastatic breast cancer.2 

The collective results of Lilly's clinical development program continue to differentiate Verzenio as a CDK4/6 inhibitor. In high risk EBC, Verzenio has shown a persistent and deepening benefit beyond the two-year treatment period in the monarchE trial, the only adjuvant study designed specifically to investigate a CDK4/6 inhibitor in a high risk population.2 In metastatic breast cancer, Verzenio has demonstrated statistically significant OS in the Phase 3 MONARCH 2 study.3 Verzenio has shown a consistent and generally manageable safety profile across clinical trials.

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 diarrhea 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