PARP inhibitor · small molecule

talazoparib

9 active trials across 5 of our biomarkers, targeting PARP. 4 active approvals for a biomarker on marked.bio.

Also known as BMN 673, Talzenna.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

Therapy	Biomarker	Tumour	United States	European Union
talazoparib FDA, 2018 locally advanced or metastatic HER2-negative, deleterious germline BRCA Label 1.1. Year confirmed: FDA approval announced 16/10/2018. Source EU (EMA), 2019 locally advanced or metastatic HER2-negative, germline BRCA1/2 MA 20/06/2019. The EU prostate combination with enzalutamide is not biomarker-restricted. Source Talzenna	BRCA1/2 mutation	breast	Approved 2018	Approved 2019
In the US label EMBRACA vs physician's choice chemotherapy, 287 vs 144 patients PFS 8.6 months vs 5.6 months, HR 0.54 (0.41-0.71)Response 50% vs 18%OS 19.3 months vs 19.5 months, HR 0.85 (0.67-1.07), not significant Serious side effects 32%Stopped for side effects 5%Fatal 1% Trial details and side effects Patients germline BRCA-mutated HER2-negative advanced breast cancer (NCT01945775) Most common side effects fatigue 62%, nausea 49%, headache 33%, vomiting 25%, alopecia 25%, diarrhoea 22% (286 patients) Notes Talzenna US label rev. 06/2025. Source US label In the EU product information EMBRACA vs physician's choice chemotherapy, 287 vs 144 patients PFS 8.6 months vs 5.6 months, HR 0.54 (0.41-0.71)Response 63% vs 27% (measurable disease, 219 vs 114)OS 19.3 months vs 19.5 months, HR 0.85 (0.67-1.07), not significant Trial details and side effects Patients germline BRCA-mutated HER2-negative advanced breast cancer (NCT01945775) Most common side effects fatigue 62%, nausea 49%, headache 33%, vomiting 25%, alopecia 25%, diarrhoea 22% (286 patients) Notes EU SmPC section 5.1 (EMBRACA; response by investigator). Side effects from the US label. Source EU product information
talazoparib with enzalutamide FDA, 2023 mCRPC with HRR gene mutation Label 1.2: HRR gene-mutated mCRPC. The EU combination is not biomarker-restricted. Year confirmed: FDA approval announced 20/06/2023. Source FDA, 2026 metastatic castration-sensitive (androgen pathway modulation-naive or -sensitive), HRR gene mutation FDA approval 26/10/2026 (as reported by ASCO Post). HRR genes include BRCA1 and BRCA2. Source TalzennaBroader labelenzalutamide page	BRCA1/2 mutation	prostate	Approved 2023	Not approved
TALAPRO-2 (HRR-mutated cohort) vs placebo + enzalutamide, 200 vs 199 patients rPFS not reached vs 13.8 months, HR 0.45 (0.33-0.61)OS 45.1 months vs 31.1 months, HR 0.62 (0.48-0.81) Serious side effects 30%Stopped for side effects 10%Fatal 1.5% Trial details and side effects Patients HRR gene-mutated mCRPC (NCT03395197) Most common side effects anaemia (haemoglobin decreased) 79%, fatigue 49%, nausea 21%, decreased appetite 20%, fractures 14% (197 patients) Later trial BRCA-mutated subgroup (71 vs 84 patients, exploratory): rPFS HR 0.20 (0.11-0.36); OS HR 0.48 (0.31-0.75). Notes Talazoparib with enzalutamide. Talzenna US label rev. 06/2025. Source US label

Biomarkers

Biomarker	Active trials	All trials	Furthest active phase
BRCA1/2 mutation	8	23	Phase 2
KRAS G12C	1	2	Phase 2
KRAS G12D	1	2	Phase 2
MSI-H / dMMR	1	1	Phase 2
IDH1/2 mutation	0	1	–

Trials

9 of 26 trials shown

Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial

Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2022Primary completion 2026-12 NCT05327010

ZEN-3694talazoparib

Patients in Cohort 4 must have KRAS mutated advanced solid tumors.

KRAS G12CKRAS G12DBRCA1/2 mutationAdvanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency

Recruiting Phase 2 Seoul National University Hospital Started 2021Primary completion 2027-05 NCT04892693

talazoparib FDA EU

Germline or Somatic BRCA1/2 mutation

BRCA1/2 mutationAdvanced Breast Cancer
Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial

Recruiting Phase 2 Massachusetts General Hospital Started 2021Primary completion 2027-03 NCT03990896

talazoparib FDA EU

Metastatic breast cancer with deleterious somatic BRCA 1 or 2 mutations detectable by cell-free circulating tumor DNA, by CLIA certified clinical assay (includin…

BRCA1/2 mutationBreast Cancer
PALbociclib Endocrine Therapy Followed by Talazo Vs. Talazoz-Atezo Study

Recruiting Phase 2 Samsung Medical Center Started 2021Primary completion 2025-12 NCT04819243

talazoparib FDA EUatezolizumab

Confirmed germline pathogenic BRCA1 and/or BRCA2 mutation or 35 HRD-related gene alterations (see Appendix 16.5)

BRCA1/2 mutationPremenopausal HR+/HER2- Metastatic Breast Cancer
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2021Primary completion 2026-07 NCT04550494

talazoparib FDA EU

Deleterious BRCA1 or BRCA2 mutations

BRCA1/2 mutationAnatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Clinical Stage III Gastric Cancer AJCC v8
Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

Active, not recruiting Phase 1/2 Kari Wisinski Started 2019Primary completion 2024-07 NCT03911973

gedatolisibtalazoparib FDA EU

Phase II Cohort B \[CLOSED\]: Patients with advanced HER2 negative breast cancer and a germline BRCA1 or 2 (1/2) mutation

BRCA1/2 mutationStatus may be outdated, last updated 2024-06-07TNBC - Triple-Negative Breast Cancer
FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test

Recruiting Phase 2 Erasmus Medical Center Started 2019Primary completion 2025-12 NCT06193525

talazoparib FDA EU

the patient must have a proven germline or somatic BRCA1 and/or BRCA2 mutation The Bloom \& Richardson grading is always based on the primary tumor.

BRCA1/2 mutationAdvanced Breast Cancer
Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer

Active, not recruiting Phase 2 Dana-Farber Cancer Institute Started 2016Primary completion 2023-11 NCT02912572

avelumabtalazoparibaxitinib

MSI-H as determined by immunohistochemical complete loss of expression (absence of nuclear immu…

MSI-H / dMMRMetastatic Endometrial Cancer
Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes

Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2014Primary completion 2026-12 NCT02286687

talazoparib FDA EU

or germline mutation in BRCA1 or BRCA 2 (not breast or ovarian cancer)

BRCA1/2 mutationAdvanced Malignant Neoplasm, ATM Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

Completed Phase 3 Pfizer Started 2013 NCT01945775

talazoparib FDA EUPhysician's-Choice

Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor

BRCA1/2 mutationBreast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Talazoparib Maintenance Therapy in Triple-negative Breast Cancer

Unknown status Phase 2 Yonsei University Started 2021 NCT04755868

talazoparib FDA EU

Patients who can receive germline BRCA1/2 mutation test or patients with previously known germline BRCA1/2 mutation status.

BRCA1/2 mutationTNBC - Triple-Negative Breast Cancer
Talazoparib - Carboplatin for Recurrent High-grade Glioma With DDRd

Completed Phase 2 The University of Hong Kong Started 2021 NCT04740190

talazoparibcarboplatin

IDH mutation

IDH1/2 mutationRecurrent Glioma, Recurrent Glioblastoma, Poly ADP Ribose Polymerase (PARP) Inhibitor, PTEN Gene Inactivation
Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes

Completed Phase 2 Case Comprehensive Cancer Center Started 2020 NCT04187833

nivolumabtalazoparib FDA EU

Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes

BRCA1/2 mutationMetastatic or Unresectable Melanoma
A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors

Terminated Phase 1/2 Pfizer Started 2018 NCT03637491

avelumabbinimetinibtalazoparib

Phase 2 only: Stage IIIb/IV NSCLC or other advanced solid tumors with documented positive KRAS or NRAS mutation as determined using a validated test performed in a CAP/CLIA-certified laboratory (or oth…

KRAS G12CKRAS G12DPancreatic Cancer
Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

Terminated Phase 2 Pfizer Started 2018 NCT03499353

talazoparib FDA EU

Germline BRCA 1/2 Mutation Positive

BRCA1/2 mutationEarly Breast Cancer
Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors

Terminated Phase 2 Pfizer Started 2018 NCT03565991

avelumabtalazoparib FDA EU

Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors

BRCA1/2 mutationLocally Advanced or Metastatic Solid Tumors, Genes, BRCA 1
A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer

Withdrawn Phase 2 Pfizer Started 2016 NCT02836028

talazoparib FDA EUtemozolomide

Have a deleterious germline or a somatic BRCA1 or BRCA2 mutation, or a high diagnostic HRD test score (myChoice score ≥ 42), which represents a loss of DN…

BRCA1/2 mutationOvarian Cancer
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 Phase 2 National Cancer Institute (NCI) Started 2015 NCT02326844

talazoparib FDA EU

Recurrent, and/or metastatic germline breast cancer (BRCA) 1/2 mutation-associated ovarian cancer, with progression on a poly (ADP-ribose) polymerase (PARP) inhi…

BRCA1/2 mutationOvarian Cancer
Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer

Completed Phase 2 M.D. Anderson Cancer Center Started 2015 NCT02282345

talazoparib FDA EU

Identified deleterious mutation in BRCA 1 or 2 genes (this does not include variants of uncertain significance)

BRCA1/2 mutationBreast Adenocarcinoma, Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, HER2/Neu Negative
Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations

Completed Phase 1/2 National Cancer Institute (NCI) Started 2014 NCT01989546

talazoparib FDA EU

Adult patients with documented deleterious breast cancer 1 and breast cancer 2 (BRCA 1 or 2) mutations with histologically confirmed ovarian, primary peritoneal, breast, prostate, pancreas, ga…

BRCA1/2 mutationAdvanced Ovarian Cancer, Primary Peritoneal Cancer, Advanced Breast Cancer, Advanced Solid Tumors
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 Phase 2 Pfizer Started 2013 NCT02034916

talazoparib FDA EU

Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation

BRCA1/2 mutationBreast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors

Completed Phase 1 Artios Pharma Started 2021 NCT04991480

ART4215talazoparib FDA EUniraparib FDA EU

Optional baseline biopsy for BRCA1/2 mutations and prior PARP inhibitor

BRCA1/2 mutationAdvanced Cancer, Metastatic Cancer, Breast Cancer
BrUOG 390: Neoadjuvant Treatment With Talazoparib

Terminated Phase 1 Brown University Started 2021 NCT04598321

talazoparib FDA EU

Documented mutation in BRCA1 or BRCA2 by genetic or commercial somatic testing.

BRCA1/2 mutationBRCA1 Mutation, BRCA2 Mutation, Ovarian Cancer, Fallopian Tube Cancer
A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors

Completed Phase 1 Pfizer Started 2017 NCT03343054

talazoparib FDA EU

Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation by Myriad Genetics' BRACAnalysis CDx test.

BRCA1/2 mutationNeoplasms, Breast Neoplasms
Study of BMN-673 With Carboplatin and Paclitaxel in Patients With Advanced BRCA-mutated Solid Tumor or Triple Negative Metastatic Breast Cancer

Terminated Phase 1 Pamela Munster Started 2015 NCT02358200

talazoparib FDA EUcarboplatinpaclitaxel

Patients with advanced malignancies that have germline and/or somatic BRCA mutations (cohort gBRCA) Or

BRCA1/2 mutationTriple Negative Metastatic Breast Cancer, BRCA-mutated Solid Tumor
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

Completed Phase 1 Pfizer Started 2011 NCT01286987

talazoparib FDA EU

Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease.

BRCA1/2 mutationAdvanced or Recurrent Solid Tumors, Breast Neoplasms, Ovarian Cancer, Epithelial, Ewing Sarcoma