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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, and in combination with Xtandi (enzalutamide) in patients with homologous recombination repair gene (ATM, ATR, BRCA1/2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C)-mutated metastatic castration-resistant prostate cancer (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Talazoparib Talzenna BMN673 PARP Inhibitor (Pan) 31 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, and in combination with Xtandi (enzalutamide) in patients with homologous recombination repair gene (ATM, ATR, BRCA1/2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C)-mutated metastatic castration-resistant prostate cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
DNMT3A loss acute myeloid leukemia resistant Talazoparib Preclinical - Cell culture Actionable In a preclinical study, mouse acute myeloid leukmia cells harboring DNMT3A loss along with a FLT3-ITD mutation were resistant to Talzenna (talazoparib) in culture (PMID: 34215619). 34215619
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
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 Advanced Solid Tumor sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing IDH1 R132H demonstrated increased sensitivity to Talzenna (talazoparib)-induced growth inhibition in culture (PMID: 28148839). 28148839
PTEN loss Advanced Solid Tumor no benefit Talazoparib Phase II Actionable In a Phase II trial, Talzenna (talazoparib) treatment resulted in limited clinical benefit in patients with advanced solid tumors harboring PTEN deleterious mutations or loss (by IHC), with a clinical benefit rate of 9.4% (1/14, 1 with stable disease >/=24 weeks) and a median overall survival of 8.5 months and a median progression-free survival of 7.7 weeks (PMID: 39085400; NCT02286687). 39085400
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
ATM mutant Advanced Solid Tumor predicted - sensitive Talazoparib Phase II Actionable In a Phase II trial (TAPUR), Talzenna (talazoparib) treatment resulted in a disease control rate of 41% and an objective response rate of 7% in advanced solid tumor patients harboring ATM mutation (n=28) or deletion (n=1) with 1 partial response in a thyroid cancer patient and 1 partial response in a lung cancer patient ongoing at 73 weeks (Cancer Res (2025) 85 (8_Supplement_2): CT228). detail...
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 Talzenna (talazoparib)-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
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
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 Talzenna (talazoparib)-induced growth inhibition in culture (PMID: 28148839). 28148839
TET2 loss acute myeloid leukemia sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, Talzenna (talazoparib) decreased colony formation in mouse acute myeloid leukemia cells harboring TET2 loss along with a FLT3-ITD mutation in culture (PMID: 34215619). 34215619
DNMT3A loss TET2 loss acute myeloid leukemia sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, Talzenna (talazoparib) decreased colony formation in murine acute myeloid leukemia cells harboring TET2 and DNMT3A loss along with a FLT3-ITD mutation in culture (PMID: 34215619). 34215619
ATM G1676fs cholangiocarcinoma predicted - sensitive Talazoparib Case Reports/Case Series Actionable In a Phase II trial, Talzenna (talazoparib) treatment resulted in a clinical benefit rate (CBR) of 22.8% (18/79, 1 complete and 7 partial responses, 10 with stable disease >/=24 weeks) in patients with advanced solid tumors harboring mutations in DNA damage repair genes, including a partial response lasting 16 weeks in a cholangiocarcinoma cancer patient harboring ATM G1676fs (PMID: 39085400; NCT02286687). 39085400
PTEN inact mut Advanced Solid Tumor no benefit Talazoparib Phase II Actionable In a Phase II trial, Talzenna (talazoparib) treatment resulted in limited clinical benefit in patients with advanced solid tumors harboring PTEN deleterious mutations or loss (by IHC), with a clinical benefit rate of 9.4% (1/14, 1 with stable disease >/=24 weeks) and a median overall survival of 8.5 months and a median progression-free survival of 7.7 weeks (PMID: 39085400; NCT02286687). 39085400
BRAF V600E NRAS Q61R melanoma sensitive Talazoparib Preclinical - Pdx Actionable In a preclinical study, Talzenna (talazoparib) treatment inhibited tumor growth and led to improved survival compared to controls in a melanoma patient-derived xenograft (PDX) model harboring BRAF V600E and NRAS Q61R (PMID: 37729428). 37729428
PTEN Y336* breast cancer sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, breast cancer cells expressing PTEN Y336* demonstrated increased sensitivity to Talzenna (talazoparib) compared to cells expressing wild-type Pten in culture (PMID: 25946202}. 25946202
ATM S1599* appendix cancer predicted - sensitive Talazoparib Case Reports/Case Series Actionable In a Phase II trial, Talzenna (talazoparib) treatment resulted in a clinical benefit rate (CBR) of 22.8% (18/79, 1 complete and 7 partial responses, 10 with stable disease >/=24 weeks) in patients with advanced solid tumors harboring mutations in DNA damage repair genes, including a partial response lasting 12 weeks in an appendiceal cancer patient harboring ATM S1599* (PMID: 39085400; NCT02286687). 39085400
PTEN negative Advanced Solid Tumor sensitive 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 Talzenna (talazoparib) (PMID: 23881923). 23881923
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 Talzenna (talazoparib)-induced growth inhibition in culture (PMID: 28148839). 28148839
BRAF V600E NRAS Q61K melanoma sensitive Talazoparib Preclinical - Pdx Actionable In a preclinical study, Talzenna (talazoparib) treatment inhibited tumor growth and led to improved survival compared to controls in a melanoma patient-derived xenograft (PDX) model harboring BRAF V600E and NRAS Q61K (PMID: 37729428). 37729428

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03395197 Phase III Talazoparib Talazoparib + NHT vs. NHT Monotherapy in DDR+ mCRPC (TALAPRO-2) Active, not recruiting USA | SWE | POL | NZL | NOR | ITA | ISR | HUN | GBR | FRA | FIN | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG 7
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 | GBR | FRA | ESP | DEU 0
NCT02316834 Phase I Talazoparib POSITION: A PilOt Study of InducTion PARP InhibitiON in Ovarian Cancer Completed 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) Terminated AUS 0
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
NCT01286987 Phase I Talazoparib Study of BMN 673, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors Completed USA | GBR 0
NCT02401347 Phase II Talazoparib Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors Completed USA 0
NCT04170946 Phase I Talazoparib Talazoparib and Thoracic RT for ES-SCLC Recruiting CAN 0
NCT02154490 Phase II Docetaxel Nivolumab Palbociclib Durvalumab Ipilimumab + Nivolumab Fexagratinib 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
NCT06844383 Phase II Enzalutamide + Talazoparib Talazoparib A Study of Talazoparib with or Without Enzalutamide in People with Prostate Cancer Who Have Previously Received Abiraterone Acetate (TALENT) Not yet recruiting USA 0
NCT02997176 Phase I Talazoparib An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) Completed USA 0
NCT03148795 Phase II Talazoparib A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Completed USA | POL | NLD | ITA | HUN | GBR | FRA | ESP | DEU | BRA | BEL | AUT | AUS 1
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
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 | POL | ITA | ISR | IRL | GBR | FRA | ESP | DEU | BRA | BEL | AUS 4
NCT03042910 Phase I Talazoparib A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors Completed 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 | AUS 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
NCT05725200 Phase II Dasatinib Palbociclib Gemcitabine Trastuzumab Cetuximab Pertuzumab Panobinostat Alectinib Venetoclax Larotrectinib Encorafenib Everolimus Idelalisib Crizotinib Pembrolizumab Methotrexate Talazoparib Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer (EVIDENT) Recruiting NOR 0
NCT03964532 Phase Ib/II Talazoparib Avelumab + Talazoparib TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer Active, not recruiting USA 0
NCT04550494 Phase II Talazoparib Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations Recruiting USA 0
NCT06193525 Phase II Talazoparib FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test (FUTURE) Recruiting NLD 0
NCT02693535 Phase II Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Futibatinib Ipilimumab + Nivolumab Palbociclib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf 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
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
NCT02921919 Phase II Talazoparib Open-Label Extension and Safety Study of Talazoparib Completed USA | POL | HUN | GBR | FRA | DEU | CAN 2
NCT04462809 Phase II Talazoparib Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Malignant MESOthelioma (TALAMESO) Unknown status 0
NCT03968406 Phase I Talazoparib Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers Recruiting USA 0
NCT02282345 Phase II Talazoparib Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer Completed USA 0
NCT02537561 Phase I Talazoparib Cisplatin + Gemcitabine Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors Withdrawn 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
NCT03974217 Phase I Talazoparib Talazoparib for Cohesin-Mutated AML and MDS with Excess Blasts Recruiting USA 0
NCT04756765 Phase II Talazoparib Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer Recruiting USA 0
NCT04598321 Phase I Talazoparib BrUOG 390: Neoadjuvant Treatment With Talazoparib Terminated 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
NCT02997163 Phase I Talazoparib An Open-Label Pharmacokinetics and Safety Study of Talazoparib Completed USA | CAN 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
NCT02925234 Phase II Crizotinib Sunitinib Niraparib Olaparib Lorlatinib Erdafitinib Talazoparib Dacomitinib Axitinib Panitumumab Pemigatinib The Drug Rediscovery Protocol (DRUP Trial) (DRUP) Recruiting NLD 0
NCT05097599 Phase II Binimetinib + Encorafenib Trastuzumab deruxtecan Enfortumab vedotin-ejfv Talazoparib Lorlatinib Strata PATH (Precision Indications for Approved Therapies) (Strata PATH) Terminated USA 0


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