Therapy Detail

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Therapy Name Olaparib + Temozolomide
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Olaparib Lynparza AZD2281|KU-0059436 PARP Inhibitor (Pan) 30 Lynparza (olaparib) binds to and inhibits PARP, resulting in inhibition of DNA repair and lethality in homologous-recombination deficient cells, and may be a sensitizing agent for chemotherapy and radiotherapy (PMID: 25028150, PMID: 24225019). Lynparza (olaparib) is FDA approved for treatment of ERBB2 (HER2)-negative breast cancer with deleterious or suspected deleterious germline BRCA mutations, ovarian cancer with deleterious or suspected deleterious germline BRCA mutations and received 3 or more prior therapies, metastatic pancreatic adenocarcinoma with deleterious or suspected deleterious germline BRCA mutations as a maintenance therapy, metastatic castration-resistant prostate cancer (mCRPC) with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations who progressed following enzalutamide or abiraterone, in combination with abiraterone in patients with mCRPC harboring deleterious or suspected deleterious BRCA mutations, as a maintenance therapy in recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and in epithelial ovarian, fallopian tube or primary peritoneal cancer with deleterious or suspected deleterious germline or somatic BRCA mutation, and in combination with Avastin (bevacizumab) as maintenance therapy in HDR defective epithelial ovarian, fallopian tube or primary peritoneal cancer as defined by deleterious or suspected deleterious BRCA mutation, and/or genomic instability (FDA.gov).
Temozolomide Temodar Methazolastone|TMZ Chemotherapy - Alkylating 18 Temodar (temozolomide) is a dacarbazine analog and cytotoxic alkylating agent (NCI Drug Dictionary).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ARID1A Y551Lfs*72 ARID1A Q758Rfs*75 ovarian cancer sensitive Olaparib + Temozolomide Preclinical - Cell line xenograft Actionable In a preclinical study, the combination of Lynparza (olaparib) and Temodar (temozolomide) synergistically inhibited viability of an ovarian cancer cell line harboring ARID1A Y551Lfs*72 and Q758Rfs*75 in culture and inhibited tumor growth in a cell line xenograft model (PMID: 37306706). 37306706
RAD51B del uterus leiomyosarcoma predicted - sensitive Olaparib + Temozolomide Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) and Temodar (temozolomide) combination treatment resulted in stable disease and progression-free survival lasting 980 days in a patient with advanced uterine leiomyosarcoma harboring a homozygous deletion of RAD51B (PMID: 37467452). 37467452
ARID1A Q2209Sfs*22 ovarian cancer sensitive Olaparib + Temozolomide Preclinical - Cell culture Actionable In a preclinical study, the combination of Lynparza (olaparib) and Temodar (temozolomide) inhibited viability of an ovarian cancer cell line harboring ARID1A Q2209Sfs*22 in culture (PMID: 37306706). 37306706
ARID1A Q1835* ARID1A Q2115* ovarian cancer sensitive Olaparib + Temozolomide Preclinical - Cell line xenograft Actionable In a preclinical study, the combination of Lynparza (olaparib) and Temodar (temozolomide) synergistically inhibited viability of an ovarian cancer cell line harboring ARID1A Q1835* and Q2115* in culture and inhibited tumor growth in a cell line xenograft model (PMID: 37306706). 37306706
PALB2 del uterus leiomyosarcoma predicted - sensitive Olaparib + Temozolomide Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) and Temodar (temozolomide) combination treatment resulted in stable disease and progression-free survival lasting 381 days in a patient with advanced uterine leiomyosarcoma harboring a homozygous deletion of PALB2 (PMID: 37467452). 37467452
ARID1A Q586* ovarian cancer sensitive Olaparib + Temozolomide Preclinical - Cell culture Actionable In a preclinical study, the combination of Lynparza (olaparib) and Temodar (temozolomide) inhibited viability of an ovarian cancer cell line harboring ARID1A Q586* in culture (PMID: 37306706). 37306706

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05128734 Phase II Olaparib + Temozolomide Temozolomide Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC) Not yet recruiting CAN 0
NCT04394858 Phase II Olaparib + Temozolomide Temozolomide Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer Recruiting USA 0
NCT05432791 Phase II Pazopanib Olaparib + Temozolomide Trabectedin Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working Recruiting USA 1
NCT01858168 Phase I Olaparib + Temozolomide Phase I Study of Olaprib and Temozolomide for Ewings Sarcoma Active, not recruiting USA 0
NCT03212742 Phase Ib/II Olaparib + Temozolomide Phase I/IIa Study of Concomitant Radiotherapy With Olaparib and Temozolomide in Unresectable High Grade Gliomas Patients (OLA-TMZ-RTE-01) Recruiting FRA 0
NCT03880019 Phase II Olaparib + Temozolomide Olaparib and Temozolomide in Treating Patients With Advanced, Metastatic, or Unresectable Uterine Leiomyosarcoma Active, not recruiting USA 0
NCT04166435 Phase II Olaparib + Temozolomide TMZ + Olaparib for MGMT Hypermethylated Colorectal Cancer Completed USA 0


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