Therapy Detail

Therapy Name Abemaciclib
Therapy Description

Verzenio (abemaciclib) is a dual CDK4/6 inhibitor, which inhibits Rb1 protein phosphorylation and may induce cell cycle arrest and prevent growth in cancer cells (PMID: 24919854). Verzenio (abemaciclib) is FDA approved as a monotherapy and in combination with Faslodex (fulvestrant) in patients with hormone receptor-positive (ESR, PGR) and ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Abemaciclib Verzenio LY2835219 CDK4/6 Inhibitor 8 Verzenio (abemaciclib) is a dual CDK4/6 inhibitor, which inhibits Rb1 protein phosphorylation and may induce cell cycle arrest and prevent growth in cancer cells (PMID: 24919854). Verzenio (abemaciclib) is FDA approved as a monotherapy and in combination with Faslodex (fulvestrant) in patients with hormone receptor-positive (ESR, PGR) and ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown melanoma not applicable Abemaciclib Phase I Actionable In a Phase I trial, treatment with Abemaciclib (LY2835219) in melanoma patients resulted in a disease control rate of 27% (7/26), a partial response in one patient and six patients with stable disease (PMID: 27217383). 27217383
Unknown unknown ovarian cancer not applicable Abemaciclib Phase I Actionable In a Phase I trial, two ovarian cancer patients treated with Abemaciclib (LY2835219) demonstrated stable disease while another ovarian cancer patient achieved a partial response (PMID: 27217383). 27217383
Unknown unknown ovarian cancer not applicable Abemaciclib Preclinical Actionable In a preclinical study, LY2835219 alone, and in combination with Gemzar (gemcitabine), reduced tumor growth in xenograft models of solid tumors including ovarian cancers (PMID: 24919854). 24919854
Unknown unknown ovarian cancer not applicable Abemaciclib Preclinical Actionable In a preclinical study, LY2835219 treatment reduced tumor growth and increased survival in ovarian cancer xenograft models (American Association for Cancer Research; 2013 Apr 6-10; Abstract LB-122). detail...
CDKN2A loss KRAS wild-type non-small cell lung carcinoma sensitive Abemaciclib Phase I Actionable In a Phase I trial, a squamous non-small cell lung carcinoma patient with KRAS wild-type and loss of CDKN2A demonstrated a partial response when treated with Abemaciclib (LY2835219) (PMID: 27217383). 27217383
CDKN2A loss chordoma sensitive Abemaciclib Preclinical - Cell culture Actionable In a preclinical study, Abemaciclib (LY2835219) inhibited growth of chordoma cell lines with CDKN2A loss and loss of p16 protein expression in culture (PMID: 26183925). 26183925
Unknown unknown Her2-receptor positive breast cancer not applicable Abemaciclib Preclinical - Pdx & cell culture Actionable In a preclinical study, an ERBB2 (HER2)-receptor positive breast cancer cell line xenograft model treated with Abemaciclib (LY2835219) demonstrated delayed tumor growth and in culture, resulted in some decreased cell viability (PMID: 26977878). 26977878
Unknown unknown glioblastoma multiforme not applicable Abemaciclib Phase I Actionable In a Phase I trial, three patients with glioblastoma demonstrated stable disease when treated with Abemaciclib (LY2835219) (PMID: 27217383). 27217383
KRAS mutant TP53 mutant colorectal cancer sensitive Abemaciclib Phase I Actionable In a Phase I trial, a colorectal cancer patient co-harboring a KRAS mutation and TP53 mutation demonstrated sensitivity when treated with Abemaciclib (LY2835219), which resulted in stable disease (PMID: 27217383). 27217383
Unknown unknown non-small cell lung carcinoma not applicable Abemaciclib Phase I Actionable In a Phase I trial, treatment with Abemaciclib (LY2835219) in patients with non-small cell lung carcinoma resulted in a disease control rate of 49% (33/68), including 46% (31/68) with stable disease and 3% (2/68) with a partial response, and a 6 month PFS of 26% (PMID: 27217383). 24795392 27217383
CDKN2A loss NRAS mutant melanoma sensitive Abemaciclib Phase I Actionable In a Phase I trial, Abemaciclib (LY2835219) resulted in a partial response in a melanoma patient with CDKN2A loss and NRAS mutation (PMID: 27217383). detail... 27217383
KRAS mutant non-small cell lung carcinoma sensitive Abemaciclib Phase I Actionable In a Phase I trial, treatment with Abemaciclib (LY2835219) in non-small cell lung carcinoma patients harboring a KRAS mutation resulted in a disease control rate of 55% (16/29) and a median PFS of 2.8 months (LY2835219) (PMID: 27217383). 27217383
Unknown unknown colorectal cancer not applicable Abemaciclib Phase I Actionable In a Phase I trial, treatment with Abemaciclib (LY2835219) in colorectal cancer patients resulted in 2 patients (13%; 2/15) with stable disease (PMID: 27217383). 27217383
Unknown unknown head and neck squamous cell carcinoma not applicable Abemaciclib Preclinical Actionable In a preclinical study, Abemaciclib (LY2835219) reduced RB and AKT activation, and inhibited cell proliferation and colony formation in head and neck squamous cell carcinoma (HNSCC) cell lines in culture, and inhibited tumor growth in HNSCC xenograft models (PMID: 26909611). 26909611
Clinical Trial Phase Therapies Title Recruitment Status
NCT02117648 Abemaciclib + Clarithromycin Abemaciclib A Study of LY2835219 in Participants With Cancer Completed
NCT03837821 Abemaciclib Window of Opportunity Trial of Abemaciclib for Bladder Cancer Recruiting
NCT02441946 Phase II Abemaciclib Loperamide Anastrozole A Phase 2 Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer Completed
NCT02152631 Phase III Erlotinib Abemaciclib A Study of LY2835219 in Participants With Previously Treated Lung Cancer Active, not recruiting
NCT02675231 Phase II Abemaciclib Trastuzumab Fulvestrant A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer Active, not recruiting
NCT02450539 Phase II Abemaciclib Docetaxel A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer Active, not recruiting
NCT03130439 Phase II Abemaciclib Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer Recruiting
NCT02644460 Phase I Abemaciclib Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors Recruiting
NCT03310879 Phase II Abemaciclib A Phase II Study of the CDK4/6 Inhibitor Abemaciclib in Patients With Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6 Recruiting
NCT02981342 Phase II Capecitabine Abemaciclib Gemcitabine Abemaciclib + LY3023414 Abemaciclib + Galunisertib A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma Active, not recruiting
NCT02079636 Phase I LY3023414 Abemaciclib Gemcitabine Pemetrexed Ramucirumab A Study of LY2835219 in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC) Active, not recruiting
NCT03220646 Phase II Abemaciclib The Purpose of This Study is to Test Any Good and Bad Effects of a Study Drug Called Abemaciclib (LY2835219) in Patients With Recurrent Brain Tumors. Recruiting
NCT02107703 Phase III Abemaciclib Fulvestrant A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer Active, not recruiting
NCT03763604 Expanded access Abemaciclib Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer Available
NCT02688088 Phase I Abemaciclib Caffeine + Dextromethorphan + Midazolam + Warfarin A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body Active, not recruiting
NCT02981940 Phase II Abemaciclib A Study of Abemaciclib in Recurrent Glioblastoma Active, not recruiting
NCT03155997 Phase III Abemaciclib A Study to Compare Treatment After Surgery of Abemaciclib (LY2835219) Combined With Standard Endocrine Therapy Versus Endocrine Therapy Alone in Participants With Breast Cancer Recruiting
NCT02792725 Expanded access Abemaciclib Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer Approved for marketing
NCT02846987 Phase II Abemaciclib Study of Abemaciclib in Dedifferentiated Liposarcoma Recruiting
NCT02308020 Phase II Abemaciclib A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer That Has Spread to the Brain Active, not recruiting
NCT02747004 Phase II Abemaciclib + Loperamide Abemaciclib Abemaciclib + Tamoxifen A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1) Active, not recruiting