Verzenio (abemaciclib) / Eli Lilly - LARVOL DELTA

First-line cyclin-dependent kinase 4 and 6 inhibitors in combination with an aromatase inhibitor for HR+/HER2- metastatic breast cancer: A real-world cost-effectiveness assessment in a US Medicare-eligible population. (PubMed, J Manag Care Spec Pharm) - "Sensitivity analyses further supported no differences in LYs or total costs between CDK4/6is. Based on effectiveness and cost estimates from real-world data, our analyses suggest that palbociclib, ribociclib, and abemaciclib produce similar life expectancy and health care costs in US patients aged 65 years and older with HR+/HER2- mBC."

Clinical • HEOR • Journal • Medicare • Real-world evidence • Reimbursement • US reimbursement • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • HER-2

Abemaciclib rechallenge after progression on abemaciclib plus endocrine therapy in patients with hormone receptor-positive and HER2-negative metastatic breast cancer: Results from the Phase Ⅱ AGAIN Study (WJOG14220B) (ESMO 2025) - No abstract available

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Imlunestrant plus abemaciclib versus fulvestrant plus abemaciclib in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC): An indirect treatment comparison (ITC) of three phase 3 trials (ESMO 2025) - No abstract available

Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

AMBRE: Phase III Randomized Study Comparing Mono-Chemotherapy (CT) vs Abemaciclib + Endocrine Therapy (ET) in HR+/HER2– Advanced Breast Cancer (ABC) with High Visceral Tumor Burden (ESMO 2025) - No abstract available

Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Lasofoxifene acts as a selective agonist in the bone microenvironment (ENDO 2025) - P3 | "ELAINE-III [NCT05696626] is a clinical trial currently investigating the efficacy of lasofoxifene and abemaciclib compared to fulvestrant abemaciclib combination therapy for advanced or metastatic ER+ breast cancer with an ESR1-mutation...Additionally, drug synergism studies with lasofoxifene and the NCI NExT Oncology Interrogation Tools Set of 555 drugs were performed to identify pathways which were vulnerable in Elacestrant-treated cells. This data will translate into novel treatment combinations which are targeted to bone metastasis in pre-clinical models. This study has determined that lasofoxifene is protective in the bone microenvironment, unlike other new-generation endocrine therapies, and future directions include evaluating the ramifications of this activity on bone metastasis progression."

Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER

Lasofoxifene acts as a selective agonist in the bone microenvironment (ENDO 2025) - P3 | "ELAINE-III [NCT05696626] is a clinical trial currently investigating the efficacy of lasofoxifene and abemaciclib compared to fulvestrant abemaciclib combination therapy for advanced or metastatic ER+ breast cancer with an ESR1-mutation...Additionally, drug synergism studies with lasofoxifene and the NCI NExT Oncology Interrogation Tools Set of 555 drugs were performed to identify pathways which were vulnerable in Elacestrant-treated cells. This data will translate into novel treatment combinations which are targeted to bone metastasis in pre-clinical models. This study has determined that lasofoxifene is protective in the bone microenvironment, unlike other new-generation endocrine therapies, and future directions include evaluating the ramifications of this activity on bone metastasis progression."

Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER

Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7) (clinicaltrials.gov) - P2 | N=31 | Terminated | Sponsor: University of Milano Bicocca | Active, not recruiting ➔ Terminated; Difficulties in patient recruitment

Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Jul 2026 ➔ Jul 2027 | Trial primary completion date: Jul 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CDK4

Baseline risk variability by eligibility criteria in Cohort 1 of the monarchE trial for high-risk HR-positive, HER2-negative breast cancer. (PubMed, Breast Cancer) - "This study highlights the prognostic variability among high-risk subgroups aligned with monarchE Cohort 1 criteria. Individualized risk assessment will be key to optimizing the benefit of adjuvant therapy in HR-positive, HER2-negative breast cancer."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Advances in breast cancer therapy: "Exploring the therapeutic potential of CDK 4/6 inhibitors and their clinical impact.". (PubMed, Curr Probl Cancer) - "With the discovery of Inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6), such as ribociclib, palbociclib, and abemaciclib, the treatment of advanced HR+/HER2- breast cancer has shifted. This review comprehensively examines the utilization strategies of CDK 4/6 inhibitors across various breast cancer subtypes, explores the mechanism of resistance, and highlights potential applications in combination with other treatments. Through a detailed analysis of clinical trials and real-world data, The review highlights how CDK4/6 inhibitors have revolutionized the treatment landscape for breast cancer, paving the way for optimized treatment outcomes."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

eIF4A controls translation of estrogen receptor alpha and is a therapeutic target in advanced breast cancer. (PubMed, Proc Natl Acad Sci U S A) - P1/2 | "In an early clinical trial (NCT04092673), the eIF4A inhibitor zotatifin was combined with either fulvestrant or fulvestrant plus CDK4 inhibitor, abemaciclib, in patients with acquired resistance to these agents. Multiple clinical responses including a handful of durable regressions were observed, with little toxicity. Thus, eIF4A inhibition could be useful for treating ER+ breast cancer resistant to other modalities."

Journal • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CCND1 • EIF4A1 • EIF4A2 • EIF4E • ER

Development of CDK4/6 Inhibitors in Gastrointestinal Cancers: Biomarkers to Move Forward. (PubMed, Curr Issues Mol Biol) - "In gastrointestinal cancers, some of these biomarkers have also proven valuable in predicting sensitivity to CDK4/6 inhibitors and would lead markers to guide clinical development. Modulation of the tumor microenvironment, where immune cells are prominent components, arises as a feature of CDK4/6 inhibition and could be harnessed in therapeutic combinations."

Biomarker • Journal • Review • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • E2F1 • ER • HER-2 • KRAS

Targeted therapies in neoadjuvant breast cancer: The role of CDK4/6 and PARP inhibitors (PubMed, Bull Cancer) - "In the adjuvant setting, abemaciclib and ribociclib have shown improvements in progression-free survival (PFS) in the monarchE and NATALEE trials, respectively, leading to their approval by the European Medicines Agency. Overall, these results underscore the growing role of targeted therapies in the adjuvant management of breast cancer. The identification and validation of predictive biomarkers will be crucial in optimizing their use, both in adjuvant and neoadjuvant settings."

Journal • Review • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2

Targeting Mitochondrial Metabolism and Treatment Resistance in PancreaticCancers (ENDO 2025) - "To assess the hypothesis that combination of JD006 biguanide analogues with CDK 4/6 and CDK2/4/6 inhibitors could improve treatment outcomes for PDAC, we combined JD006 with CDK4/6 inhibitors (abemaciclib, ribociclib) or CDK2/4/6 inhibitor PF0687300 in preclinical PDAC models (Panc-1, MIA Paca-2, CFPac). These findings suggest that more potent biguanides combined with CDK inhibitors may provide a new therapeutic strategy for PDAC, addressing both the disease's molecular drivers and health disparities in affected populations. Further study is needed to explore the molecular signatures and responses in patients of diverse ancestries to optimize clinical outcomes."

Diabetes • Metabolic Disorders • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Type 2 Diabetes Mellitus • CDKN2A • KRAS

A brain-penetrant CDK4/6 inhibitor - AU3-14 shows robust anti-tumor efficacy against glioblastoma. (PubMed, Biomed Pharmacother) - P1/2 | "Despite extensive research, advances in GBM treatment have seen limited progress, with current therapy largely reliant on temozolomide (TMZ), underscoring the need for novel therapeutic strategies...More extensive pharmacokinetic studies revealed that AU3-14 efficiently crosses the blood-brain barrier, with an unbound brain-to-plasma concentration ratios (Kp,uu) of 1.2 and 0.63 at single oral doses of 10 and 30 mg/kg, respectively, which were 2-4 times higher than those of abemaciclib...Moreover, AU3-14 enhances TMZ's anti-tumor efficacy and delays the onset of TMZ resistance. These findings support the clinical phase I/IIa investigation of AU3-14 for the treatment of GBM (ACTRN12621000479808)."

Journal • Brain Cancer • Glioblastoma • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • CDKN2A

ACUTE EPIPLOIC APPENDAGITIS IN A BREAST CANCER PATIENT ON ADJUVANT ABEMACICLIB: A DIAGNOSTIC CHALLENGE AND POTENTIAL ASSOCIATION (UEGW 2025) - No abstract available

Clinical • Breast Cancer • Oncology • Solid Tumor

Abemaciclib in combination with endocrine therapy for the treatment of HR-positive/HER2-negative locally advanced/metastatic breast cancer in the UK: an observational study. (PubMed, BMC Cancer) - "These findings support the benefit of abemaciclib in women with HR+, HER2- ABC/MBC in the real-world and complement data from MONARCH 2 and 3 clinical trials."

Journal • Observational data • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration (clinicaltrials.gov) - P2 | N=44 | Recruiting | Sponsor: Medical College of Wisconsin | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2025 ➔ Jun 2027

Trial completion date • Trial primary completion date • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Advancements in Dalpiciclib for the Treatment of Breast Cancer Patients: A Review. (PubMed, Breast Cancer (Dove Med Press)) - "For the present, the CDK4/6 inhibitors that have been widely used for the treatment of breast cancer are palbociclib, abemaciclib and ribociclib. The researches about dalpiciclib with different anti-tumor drugs are ongoing to explore the efficacy and the best strategies to use dalpiciclib. This review provides an overview of the research progress on dalpiciclib across different breast cancer subtypes with various anti-tumor drugs in different treatment opportunities."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Deciphering the differential impact of CDK4 mutations on abemaciclib binding in oral squamous cell carcinoma: a precision medicine approach. (PubMed, Ir J Med Sci) - "Further studies are essentially required to enhance the precision of cancer treatment, ensuring that each patient receives the most effective therapy based on their unique genetic makeup."

Journal • Oncology • Oral Cancer • Squamous Cell Carcinoma • CDK4

Abemaciclib induces G1 arrest and lysosomal dysfunction in canine melanoma cells: synergistic effects with fenbendazole. (PubMed, Front Vet Sci) - "These findings demonstrate that abemaciclib exerts potent antitumor effects in canine melanoma by inducing cell cycle arrest and disrupting lysosomal function. Its synergistic interaction with fenbendazole suggests a potential combinatorial therapeutic approach for canine melanoma."

Journal • Melanoma • Oncology • Solid Tumor • HER-2

Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: Duke University | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jun 2025 | Trial primary completion date: Dec 2025 ➔ Jun 2025

Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

NCI-2022-04099: Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Breast Cancer • Hormone Receptor Positive Breast Cancer • NUT Midline Carcinoma • Oncology • Pediatrics • Solid Tumor • NUTM1

Physiologically Based Pharmacokinetic Model to Assess the Drug-Drug-Gene Interaction Potential of Belzutifan in Combination With Cyclin-Dependent Kinase 4/6 Inhibitors. (PubMed, JCO Precis Oncol) - P1, P1/2 | "Our simulations predict that belzutifan decreases the exposure of combination therapies metabolized via CYP3A, with the severity of interaction dependent on CYP2C19 and UGT2B17 phenotypes."

Journal • PK/PD data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Von Hippel-Lindau Syndrome • CYP2C19 • UGT2B17