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) 25 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
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 R132C high grade 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
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
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
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
IDH1 R132H high grade 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 high grade glioma sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, Talzenna (talazoparib) treatment inhibited viability of immortalized astrocytes expressing IDH1 R132H in culture (PMID: 34118569). 34118569
PTEN negative Advanced Solid Tumor conflicting Talazoparib Preclinical - Cell culture Actionable In a preclinical study, PTEN-deficient cancer cell lines with DNA repair deficiency demonstrated high sensitivity to the PARP inhibitor, Talazoparib (BMN-673) (PMID: 23881923). 23881923
PTEN negative Advanced Solid Tumor conflicting Talazoparib Phase II Actionable In a Phase II trial, Talzenna (talazoparib) treatment did not result in significant clinical benefit in patients with advanced solid tumors harboring PTEN mutation or loss (by IHC), with one patient harboring a PTEN mutation achieved a prolonged stable disease as best response in a cohort of 13 patients (Mol Cancer Ther 2018;17(1 Suppl):Abstract nr A096; NCT02286687). detail...
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
PTEN mutant Advanced Solid Tumor no benefit Talazoparib Phase II Actionable In a Phase II trial, Talzenna (talazoparib) treatment did not result in significant clinical benefit in patients with advanced solid tumors harboring PTEN mutation or loss (by IHC), with one patient harboring a PTEN mutation achieved a prolonged stable disease as best response in a cohort of 13 patients (Mol Cancer Ther 2018;17(1 Suppl):Abstract nr A096; NCT02286687). detail...
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04462809 Phase II Talazoparib Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Malignant MESOthelioma (TALAMESO) Not yet recruiting 0
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
NCT02997176 Phase I Talazoparib An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) Completed USA 0
NCT03377556 Phase II Talazoparib Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer Completed USA | CAN 0
NCT04550494 Phase II Talazoparib Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations 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
NCT02997163 Phase I Talazoparib An Open-Label Pharmacokinetics and Safety Study of Talazoparib Completed USA | CAN 0
NCT03974217 Phase I Talazoparib Talazoparib for Cohesin-Mutated AML and MDS With Excess Blasts Recruiting USA 0
NCT04170946 Phase I Talazoparib Talazoparib and Thoracic RT for ES-SCLC Recruiting CAN 0
NCT01286987 Phase I Talazoparib Study of BMN 673, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors Completed USA 1
NCT05097599 Phase II Binimetinib + Encorafenib Trastuzumab deruxtecan Enfortumab vedotin-ejfv Talazoparib Lorlatinib Strata PATH (Precision Indications for Approved Therapies) (Strata PATH) 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
NCT02537561 Phase I Talazoparib Cisplatin + Gemcitabine Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors Withdrawn 0
NCT04598321 Phase I Talazoparib BrUOG 390: Neoadjuvant Treatment With Talazoparib Recruiting USA 0
NCT02693535 Phase II Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf 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 (TAPUR) 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) Completed USA | ITA | FRA | ESP | DEU | BEL 10
NCT04756765 Phase II Talazoparib Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer Not yet recruiting USA 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
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 Completed USA | CAN 0
NCT03968406 Phase I Talazoparib Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers Recruiting USA 0
NCT04801966 Phase 0 Palbociclib Alpelisib Atezolizumab Vemurafenib Ribociclib Talazoparib Cobimetinib Trametinib Abemaciclib Dabrafenib Nivolumab Binimetinib Pembrolizumab Encorafenib Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study (TAILOR) Recruiting 1
NCT02921919 Phase II Talazoparib Open-Label Extension and Safety Study of Talazoparib Completed USA | FRA | DEU | CAN 5
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
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 Completed USA 1
NCT02282345 Phase II Talazoparib Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer Completed USA 0
NCT02316834 Phase I Talazoparib POSITION: A PilOt Study of InducTion PARP InhibitiON in Ovarian Cancer Completed 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 | FRA | ESP | DEU 1
NCT03964532 Phase Ib/II Talazoparib Avelumab + Talazoparib TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer Recruiting USA 0
NCT02286687 Phase II Talazoparib Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes Active, not recruiting USA 0
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
NCT03148795 Phase II Talazoparib A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Active, not recruiting USA | ITA | FRA | ESP | DEU | BEL | AUT 7
NCT03395197 Phase III Talazoparib Talazoparib + NHT vs. NHT Monotherapy in DDR+ mCRPC (TALAPRO-2) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 19
NCT03042910 Phase I Talazoparib A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors Completed USA 0


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