marked.bio

CDK4/6 inhibitor · small molecule

abemaciclib

16 active trials across 11 of our biomarkers, targeting CDK4/6. 1 active approval for a biomarker on marked.bio.

Also known as LY2835219, Verzenio, Verzenios.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
imlunestrant with abemaciclib
FDA, 2026
advanced or metastatic, ESR1-mutated, after >=1 line of endocrine therapy FDA approval 18/09/2026. Source
Inluriyoimlunestrant page 		ESR1 mutation breast (ER+/HER2-) Approved 2026 Not approved

EMBER-3 (combination arm) vs imlunestrant alone, 159 with ESR1 mutation
PFS 11.1 months vs 5.5 months, HR 0.53 (0.35-0.80), exploratory subgroupResponse 35% vs 15%

Serious side effects 21%Stopped for side effects 1% (imlunestrant)Fatal 3.8%

Trial details and side effects
Patients
ESR1-mutated ER+/HER2- advanced breast cancer (NCT04975308)
Most common side effects
diarrhoea 86%, nausea 51%, fatigue 41%, infections 36%, vomiting 32%, musculoskeletal pain 25%, abdominal pain 24%, low neutrophils 86% (208 patients)
Notes
FDA approval summary (2026); benefit was seen only in the ESR1-mutated group. Side effects: Inluriyo US label, section 6 (EMBER-3 combination arm).
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
PIK3CA activating mutation 4 5 Phase 3
ESR1 mutation 3 5 Phase 3
IDH1/2 mutation 3 3 Phase 2
BRCA1/2 mutation 2 3 Phase 3
KRAS G12C 2 5 Phase 3
BRAF V600E 1 3 Phase 2
EGFR exon 19 deletion / L858R 1 3 Phase 2
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 1 2 Phase 2
KRAS G12D 1 2 Phase 3
ALK fusion 0 2 –
MSI-H / dMMR 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of abemaciclib.

  1. Eli Lilly 4
  2. AstraZeneca 2
  3. Stemline Therapeutics 1
  4. LeonaBio 1

Trials

16 of 28 trials shown

  1. A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

    Recruiting Phase 3 Eli Lilly Started 2025Primary completion 2029-05 NCT07174336

    STX-478ribociclibpalbociclib FDA EUabemaciclibanastrozoleletrozoleExemestanefulvestrant FDA EU

    Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.

    PIK3CA activating mutationBreast Neoplasms, Neoplasm Metastasis

  2. Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

    Recruiting Phase 3 AstraZeneca Started 2024Primary completion 2029-12 NCT06380751

    saruparibcamizestrantabemaciclibribociclibpalbociclibfulvestrantletrozoleanastrozoleExemestane

    Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2

    BRCA1/2 mutationAdvanced Breast Cancer

  3. Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

    Recruiting Phase 3 LeonaBio Started 2023Primary completion 2027-04 NCT05696626

    lasofoxifeneabemaciclib FDAfulvestrant

    At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast can…

    ESR1 mutationMetastatic Breast Cancer

  4. Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

    Active, not recruiting Phase 3 AstraZeneca Started 2021Primary completion 2025-06 NCT04964934

    camizestrant FDAanastrozoleletrozolepalbociclibabemaciclib FDALuteinizing hormone-releasing hormone (LHRH) agonistribociclib

    Have an ESR1 mutation in their cancer;

    ESR1 mutationER-Positive HER2-Negative Breast Cancer

  5. A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

    Active, not recruiting Phase 3 Eli Lilly Started 2014Primary completion 2017-09 NCT02152631

    abemacicliberlotinib

    A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

    KRAS G12CKRAS G12DNon Small Cell Lung Cancer

  6. A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

    Recruiting Phase 2 University of Washington Started 2025Primary completion 2028-07 NCT07112053

    CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA VaccinecapecitabineCyclin-Dependent Kinase 4 InhibitorCyclin-Dependent Kinase 6 InhibitorF-18 16 Alpha-FluoroestradiolHormone Therapyabemaciclib

    HER2 low per standard of care in breast cancer

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma

  7. A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

    Active, not recruiting Phase 2 Eli Lilly Started 2024Primary completion 2027-02 NCT06413706

    abemaciclibtemozolomide

    IDH-mutant diffuse glioma with homozygous cyclin- dependent kinase inhibitor 2A/B (CDKN2A/B) deletio…

    IDH1/2 mutationGlioma

  8. Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

    Active, not recruiting Phase 1/2 Stemline Therapeutics Started 2023Primary completion 2026-12 NCT05563220

    elacestrantalpelisib FDA EUeverolimusribociclibpalbociclib FDA EUcapivasertib FDA EUabemaciclib

    Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation by local laboratory assessment.

    PIK3CA activating mutationBreast Cancer, Metastatic Breast Cancer

  9. Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer

    Recruiting Phase 2 Northwestern University Started 2023Primary completion 2028-07 NCT06062498

    elacestrant FDA EUpalbociclibabemaciclib FDAribociclib

    Patients must have a confirmed ESR1 mutation.

    ESR1 mutationEstrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer

  10. Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance

    Active, not recruiting Phase 2 University of California, San Diego Started 2020Primary completion 2025-12 NCT04545710

    abemaciclibosimertinib FDA EU

    Tumor must harbor an EGFR activating mutation (Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q).

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-08-05Lung Cancer

  11. Genetic Testing in Guiding Treatment for Patients With Brain Metastases

    Active, not recruiting Phase 2 Alliance for Clinical Trials in Oncology Started 2019Primary completion 2025-11 NCT03994796

    abemaciclibpaxalisibentrectinibadagrasib FDA EU

    Similarly, for patients with KRAS G12C mutations, MRTX849 may be used for newly diagnosed brain metastases.

    KRAS G12CBRAF V600ECDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, NTRK Family Gene Mutation

  12. A Study of Abemaciclib in Recurrent Glioblastoma

    Active, not recruiting Phase 2 Dana-Farber Cancer Institute Started 2017Primary completion 2024-06 NCT02981940

    abemaciclib

    or astrocytoma, IDH-mutant, WHO grade 4 (1 unstained slide or 1 H\&E slide must be submitted to and reviewed by a pa…

    IDH1/2 mutationGlioblastoma

  13. Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2017Primary completion 2027-07 NCT03220646

    abemaciclib

    Histologically confirmed IDH mutant glioma, meningioma, schwanomma, PCNSL, ependymoma, or other Primary Brain Tumors that hav…

    IDH1/2 mutationBrain Tumor

  14. Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas

    Recruiting Phase 2 Alliance for Clinical Trials in Oncology Started 2015Primary completion 2028-06 NCT02523014

    VismodegibFAK Inhibitor GSK2256098capivasertib FDA EUabemaciclib

    For patients with NF2/CDKN2A/AKT1/PIK3CA/PTEN mutation, CKDN2A copy number loss, or CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1 copy number gain: Age \>= …

    PIK3CA activating mutationIntracranial Meningioma, Recurrent Meningioma, NF2 Gene Mutation

  15. A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

    Active, not recruiting Phase 1 Eli Lilly Started 2022Primary completion 2025-04 NCT05307705

    LOXO-783fulvestrant FDA EUimlunestrantabemaciclibanastrozoleletrozolepaclitaxel

    … H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)

    PIK3CA activating mutationBreast Cancer

  16. Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2021Primary completion 2026-11 NCT04633239

    abemaciclibolaparib FDA EU

    …ade serous histology is required (for the dose expansion cohort only) (data on BRCA (e.g. germline BRCA, Somatic BRCA, Neither, Unknown) and homologous recombination deficiency (HRD)/Loss of He…

    BRCA1/2 mutationRecurrent Ovarian High Grade Serous Adenocarcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma