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|Therapy Name||Abemaciclib + Pembrolizumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Abemaciclib||Verzenio||LY2835219||CDK4/6 Inhibitor 12||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, in combination with endocrine therapy as adjuvant treatment for patients with hormone receptor-positive (ESR, PGR) and ERBB2 (HER2) receptor-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score equals to or over 20% (FDA.gov).|
|Pembrolizumab||Keytruda||MK-3475||Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 95||Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous squamous cell carcinoma, MSI-H or dMMR or TMB high advanced solid tumors, CD274 (PD-L1)-expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, cervical cancer, and triple-negative breast cancer, in combination with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, with axitinib or lenvatinib in RCC, with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemotherapy for patients with esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma, and in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer (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|
|NCT03938337||Phase II||Abemaciclib + Pembrolizumab||Clinical Trial of Abemaciclib in Combination With Pembrolizumab in Patients With Metastatic or Recurrent Head and Neck Cancer||Terminated||USA||0|
|NCT02779751||Phase II||Abemaciclib + Pembrolizumab||A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer||Active, not recruiting||USA | ITA | FRA | ESP | BEL||2|
|NCT03997448||Phase II||Abemaciclib + Pembrolizumab||Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149||Active, not recruiting||USA||0|
|NCT04118036||Phase II||Abemaciclib + Pembrolizumab||Abemaciclib + Pembrolizumab In Glioblastoma||Withdrawn||USA||0|
|NCT04220892||Phase I||Abemaciclib + Pembrolizumab Pembrolizumab + Pemetrexed Disodium||Pilot Study of Pembrolizumab Combined With Pemetrexed or Abemaciclib for High Grade Glioma||Withdrawn||USA||0|