Therapy Detail

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Therapy Name Talazoparib
Synonyms
Therapy Description

Talzenna (talazoparib) is an inhibitor of PARP1 and PARP2, which prevents the DNA repair of single strand DNA breaks, thus causing the accumulation of DNA strand breaks, genomic instability and apoptosis, and leads to lethality in homologous recombination repair deficient cells (PMID: 28242752). Talzenna (talazoparib) is FDA approved for use in patients with ERBB2 (HER2)-negative breast cancer harboring deleterious or suspected deleterious germline BRCA mutations (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Talazoparib Talzenna BMN673 PARP Inhibitor (Pan) 21 Talzenna (talazoparib) is an inhibitor of PARP1 and PARP2, which prevents the DNA repair of single strand DNA breaks, thus causing the accumulation of DNA strand breaks, genomic instability and apoptosis, and leads to lethality in homologous recombination repair deficient cells (PMID: 28242752). Talzenna (talazoparib) is FDA approved for use in patients with ERBB2 (HER2)-negative breast cancer harboring deleterious or suspected deleterious germline BRCA mutations (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown lung small cell carcinoma not applicable Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment in patients with lung small cell carcinoma resulted in an objective response rate of 9% (2/23), including two patients with a partial response, and four patients with stable disease for at least 16 weeks (PMID: 28242752). 28242752
IDH1 R132C malignant glioma sensitive Talazoparib Preclinical - Patient cell culture Actionable In a preclinical study, patient-derived glioma cells harboring IDH1 R132C demonstrated increased sensitivity to Talazoparib (BMN-673)-induced growth inhibition in culture (PMID: 28148839). 28148839
IDH2 mutant acute myeloid leukemia predicted - sensitive Talazoparib Preclinical - Patient cell culture Actionable In a preclinical study, cells from a patient with acute myeloid leukemia harboring an IDH2 mutation were sensitive to treatment with Talzenna (talazoparib) in culture, demonstrating decreased colony formation (PMID: 29339439). 29339439
IDH1 R132H malignant glioma sensitive Talazoparib Preclinical - Patient cell culture Actionable In a preclinical study, patient-derived glioma cells harboring IDH1 R132H demonstrated increased sensitivity to Talazoparib (BMN-673)-induced growth inhibition in culture (PMID: 28148839). 28148839
IDH1 R132H colon carcinoma sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, colon carcinoma cells over expressing IDH1 R132H demonstrated increased sensitivity to Talazoparib (BMN-673)-induced growth inhibition in culture (PMID: 28148839). 28148839
ATM dec exp breast cancer sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, knockdown of ATM expression sensitized breast cancer cells to treatment with Talzenna (talazoparib) in culture (PMID: 23881923). 23881923
Unknown unknown Advanced Solid Tumor not applicable Talazoparib Preclinical - Cell line xenograft Actionable In a preclinical study, the Talazoparib (BMN-673) selective PARP1/2 inhibitor demonstrated antitumor activity on a variety of cell lines and xenografts with defects in DNA repair (PMID: 23881923). 23881923
ARID1A Q456* colorectal cancer sensitive Talazoparib Preclinical - Cell line xenograft Actionable In a preclinical study, Talazoparib (BMN-673) inhibited colony formation and proliferation of a human colorectal cancer cell line harboring ARID1A Q456* in culture and inhibited tumor formation in colorectal cancer xenografts harboring ARID1A Q456* (PMID: 26069190). 26069190
Unknown unknown Ewing sarcoma not applicable Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment in patients with Ewing sarcoma did not result in any objective responses, however, resulted in a clinical benefit rate of 23% (PMID: 28242752). 28242752
IDH1 R132H colorectal cancer predicted - sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, colorectal cancer cells harboring IDH1 R132H were sensitive to treatment with Talzenna (talazoparib) in culture, demonstrating decreased colony formation (PMID: 29339439). 29339439
IDH1 mutant acute myeloid leukemia predicted - sensitive Talazoparib Preclinical - Patient cell culture Actionable In a preclinical study, cells from a patient with acute myeloid leukemia harboring an IDH1 mutation were sensitive to treatment with Talzenna (talazoparib) in culture, demonstrating decreased colony formation (PMID: 29339439). 29339439
ARID1A dec exp breast cancer conflicting Talazoparib Preclinical - Cell culture Actionable In a preclinical study, human mammary epithelial cells with knockdown of ARID1A demonstrated resistance to Talazoparib (BMN673) when compared to parental cells in culture (PMID: 29669295). 29669295
ARID1A dec exp breast cancer conflicting Talazoparib Preclinical - Cell line xenograft Actionable In a preclinical study, Talazoparib (BMN-673) selectively inhibited growth and induced apoptosis in breast cancer cells with knock-down of ARID1A in culture, and inhibited tumor growth in ARID1A-deficient breast cancer cell line xenograft models (PMID: 26069190). 26069190
ARID1A dec exp ovarian cancer sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, knockdown of ARID1A resulted in increased sensitivity to Talazoparib (BMN-673) in ovarian cancer cells in culture (PMID: 26069190). 26069190
IDH1 R132H Advanced Solid Tumor sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing IDH1 R132H demonstrated increased sensitivity to Talazoparib (BMN-673)-induced growth inhibition in culture (PMID: 28148839). 28148839

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03499353 Phase II Talazoparib Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer Terminated USA 0
NCT02921919 Phase II Talazoparib Open-Label Extension and Safety Study of Talazoparib Recruiting USA | CAN 7
NCT02567396 Phase I Talazoparib Talazoparib in Treating Patients With Advanced or Metastatic Solid Tumors That Cannot Be Removed by Surgery and Liver or Kidney Dysfunction Withdrawn 0
NCT04550494 Phase II Talazoparib Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations Recruiting USA 0
NCT02537561 Phase I Talazoparib Cisplatin + Gemcitabine Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors Withdrawn 0
NCT01286987 Phase I Talazoparib Study of BMN 673, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors Completed USA 1
NCT01989546 Phase Ib/II Talazoparib Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations Completed USA 0
NCT03974217 Phase I Talazoparib Talazoparib for Cohesin-Mutated AML and MDS With Excess Blasts Recruiting USA 0
NCT02282345 Phase II Talazoparib Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer Active, not recruiting USA 0
NCT02316834 Phase I Talazoparib POSITION: A PilOt Study of InducTion PARP InhibitiON in Ovarian Cancer Active, not recruiting USA 0
NCT04672460 Phase I Talazoparib A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors Recruiting USA 0
NCT02693535 Phase II Cobimetinib + Vemurafenib Regorafenib Ipilimumab + Nivolumab Palbociclib Afatinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Crizotinib Abemaciclib Sunitinib Olaparib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer Recruiting USA 0
NCT03395197 Phase III Talazoparib Talazoparib + NHT vs. NHT Monotherapy in DDR+ mCRPC (TALAPRO-2) Recruiting USA | CAN 24
NCT03377556 Phase II Talazoparib Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer Active, not recruiting USA | CAN 0
NCT03148795 Phase II Talazoparib A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Active, not recruiting USA 13
NCT02154490 Phase II Docetaxel Nivolumab Palbociclib Durvalumab Ipilimumab + Nivolumab AZD4547 Taselisib Durvalumab + Tremelimumab Erlotinib + Rilotumumab Talazoparib Erlotinib Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer Active, not recruiting USA | CAN 0
NCT02401347 Phase II Talazoparib Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors Recruiting USA 0
NCT02326844 Phase II Talazoparib BMN 673 (Talazoparib), an Oral PARP Inhibitor, in People With Deleterious BRCA1/2 Mutation-Associated Ovarian Cancer Who Have Had Prior PARP Inhibitor Treatment Terminated USA 0
NCT04170946 Phase I Talazoparib Talazoparib and Thoracic RT for ES-SCLC Recruiting CAN 0
NCT04756765 Phase II Talazoparib Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer Not yet recruiting USA 0
NCT03042910 Phase I Talazoparib A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors Completed USA 0
NCT02286687 Phase II Talazoparib Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes Recruiting USA 0
NCT03990896 Phase II Talazoparib Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial Recruiting USA 0
NCT02997163 Phase I Talazoparib An Open-Label Pharmacokinetics and Safety Study of Talazoparib Completed USA | CAN 0
NCT04598321 Phase I Talazoparib BrUOG 390: Neoadjuvant Treatment With Talazoparib Not yet recruiting USA 0
NCT03968406 Phase I Talazoparib Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers Recruiting USA 0
NCT01945775 Phase III Gemcitabine Capecitabine Vinorelbine Talazoparib Eribulin A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) (EMBRACA) Active, not recruiting USA 15
NCT02997176 Phase I Talazoparib An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) Completed USA 0
NCT03964532 Phase Ib/II Talazoparib Avelumab + Talazoparib TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer Recruiting USA 0
NCT02034916 Phase II Talazoparib A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) Terminated USA 4


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