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| Therapy Name | Abemaciclib + Imlunestrant |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Abemaciclib | Verzenio | LY2835219 | CDK4/6 Inhibitor 14 | 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, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer, in combination with endocrine therapy as adjuvant treatment for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative, node-positive, early breast cancer at high risk of recurrence, and in combination with an aromatase inhibitor as initial therapy for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer (FDA.gov). |
| Imlunestrant | Inluriyo | LY 3484356|LY-3484356|SERD LY3484356|LY3484356 | Hormone - Anti-estrogens 31 | Inluriyo (imlunestrant) is a selective estrogen receptor degrader that binds to and causes the degradation of the estrogen receptor (ER), potentially leading to decreased ER signaling and antitumor activity (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 1050-1050). Inluriyo (imlunestrant) is FDA-approved for use in patients with estrogen receptor-positive, ERBB2 (HER2)-negative, advanced or metastatic breast cancer harboring ESR1 (ER alpha) mutations who have progressed after at least one line of endocrine therapy (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04188548 | Phase I | Abemaciclib + Imlunestrant Imlunestrant Abemaciclib + Imlunestrant + Trastuzumab Abemaciclib + Anastrozole + Imlunestrant Abemaciclib + Exemestane + Imlunestrant Alpelisib + Imlunestrant Everolimus + Imlunestrant Abemaciclib + Imlunestrant + Letrozole | A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer (EMBER) | Active, not recruiting | USA | FRA | ESP | BEL | AUS | 3 |
| NCT07191717 | Phase II | Abemaciclib + Imlunestrant | Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial | Not yet recruiting | USA | 0 |
| NCT04975308 | Phase III | Exemestane Abemaciclib + Imlunestrant Imlunestrant Fulvestrant | A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3) | Active, not recruiting | USA | TUR | NLD | ITA | GRC | FRA | ESP | DEU | CZE | BRA | BEL | AUT | AUS | ARG | 8 |