Therapy Detail

Therapy Name Talazoparib
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) 17 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRCA2 mutant triple-receptor negative breast cancer decreased response Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment in patients with triple-receptor negative breast cancer carrying a BRCA1 and/or BRCA2 mutation resulted in a lower clinical benefit rate (56% vs 89%) compared to treatment in non-triple-receptor negative breast cancer patients carrying a BRCA1/2 mutation (PMID: 28242752). 28242752
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, Talazoparib (BMN-673) (PMID: 23881923). 23881923
BRCA1 mutant ovarian cancer predicted - sensitive Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment in ovarian cancer patients harboring germline deleterious BRCA1/2 mutations resulted in an objective response rate of 48%, including one complete response, and a clinical benefit rate of 76% at 24 weeks (PMID: 28242752). 28242752
BRCA2 mutant breast cancer predicted - sensitive Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN673) treatment in breast cancer patients harboring germline deleterious BRCA1/2 mutations resulted in an objective response rate of 50% (7/14), including one patient with a complete response and six patients with a partial response, and resulted in a median progression free survival of 34.6 weeks (PMID: 28242752). 28242752
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 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
BRCA2 inact mut Her2-receptor negative breast cancer sensitive Talazoparib FDA approved Actionable In a Phase III trial (EMBRACA) that supported FDA approval, Talzenna (talazoparib) treatment resulted in significantly longer median progression-free survival (8.6 vs 5.6 months, HR=0.54, p<0.001), and higher objective response rate (62.6% vs 27.2%, OR=5.0, p<0.001) compared to standard chemotherapy in patients with advanced ERBB2 (HER2)-negative breast cancer harboring known deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 (PMID: 30110579; NCT01945775). 30110579
BRCA1 mutant breast cancer predicted - sensitive Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment in breast cancer patients harboring germline deleterious BRCA1/2 mutations resulted in an objective response rate of 50% (7/14) including one patient with a complete response and six patients with a partial response and a median progression free survival of 34.6 weeks (PMID: 28242752). 28242752
BRCA1 mutant breast cancer predicted - sensitive Talazoparib Phase I Actionable In a Phase I clinical trial, Talazoparib (BMN-673) was well-tolerated and demonstrated preliminary efficacy in patients with advanced solid tumors harboring deleterious BRCA1/2 mutations, including objective responses in 33% (2/6) of breast cancer patients carrying BRCA mutations (J Clin Oncol 31, 2013 (suppl; abstr 2580)). detail...
BRCA1 mutant triple-receptor negative breast cancer decreased response Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment in patients with triple-receptor negative breast cancer carrying a BRCA1 and/or BRCA2 mutation resulted in a lower clinical benefit rate (56% vs 89%) compared to treatment in non-triple-receptor negative breast cancer patients carrying a BRCA1/2 mutation (PMID: 28242752). 28242752
BRCA2 inact mut prostate cancer predicted - sensitive Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment demonstrated safety and preliminary efficacy in patients with advanced solid tumors harboring deleterious BRCA1/2 mutations, including one patient with prostate cancer (J Clin Oncol 31, 2013 (suppl; abstr 2580)). detail...
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
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
BRCA2 mutant ovarian cancer predicted - sensitive Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment in ovarian cancer patients harboring germline deleterious BRCA1/2 mutations resulted in an objective response rate of 48%, including one complete response, and a clinical benefit rate of 76% at 24 weeks (PMID: 28242752). 28242752
BRCA2 mutant pancreatic cancer sensitive Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment in pancreatic cancer patients resulted in four patients with a clinical benefit including a partial response in one patient harboring a BRCA2 mutation (PMID: 28242752). 28242752
BRCA1 inact mut Advanced Solid Tumor predicted - sensitive Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN673) treatment demonstrated safety and preliminary efficacy in patients with advanced solid tumors harboring deleterious BRCA1/2 mutations (J Clin Oncol 31, 2013 (suppl; abstr 2580)). detail...
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
BRCA2 inact mut Advanced Solid Tumor predicted - sensitive Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment demonstrated safety and preliminary efficacy in patients with advanced solid tumors harboring deleterious BRCA1/2 mutations (J Clin Oncol 31, 2013 (suppl; abstr 2580)). detail...
BRCA1 inact mut Her2-receptor negative breast cancer sensitive Talazoparib FDA approved Actionable In a Phase III trial (EMBRACA) that supported FDA approval, Talzenna (talazoparib) treatment resulted in significantly longer median progression-free survival (8.6 vs 5.6 months, HR=0.54, p<0.001), and higher objective response rate (62.6% vs 27.2%, OR=5.0, p<0.001) compared to standard chemotherapy in patients with advanced ERBB2 (HER2)-negative breast cancer harboring known deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 (PMID: 30110579; NCT01945775). 30110579
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
BRCA2 negative Advanced Solid Tumor sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, BRCA2-deficient cancer cell lines with DNA repair deficiency demonstrated high sensitivity to the PARP inhibitor, Talazoparib (BMN-673) (PMID: 23881923). 23881923
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
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
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
BRCA2 N136_L139del BRCA2 N136Ifs*16 BRCA2 V130_N136delinsD breast cancer resistant Talazoparib Clinical Study Actionable In a clinical study, a patient with breast cancer harboring the germline mutation, BRCA2 N136Ifs*16, acquired two BRCA2 reversion mutations, V130_N136delinsD and N136_L139del, as detected in cell-free DNA post treatment with Paraplatin (carboplatin), and subsequently, did not respond to treatment with Talazoparib (BMN-673) (PMID: 28765325). 28765325
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 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
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
BRCA1 negative Advanced Solid Tumor sensitive Talazoparib Preclinical - Cell culture Actionable In a preclinical study, BRCA1-deficient cancer cell lines with DNA repair deficiency demonstrated high sensitivity to the PARP inhibitor, Talazoparib (BMN-673) (PMID: 23881923). 23881923
Clinical Trial Phase Therapies Title Recruitment Status
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) Active, not recruiting
NCT02282345 Phase II Talazoparib Neoadjuvant BMN673 for Patients With a BRCA Deleterious Mutation Active, not recruiting
NCT02997176 Phase I Talazoparib An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) Recruiting
NCT03042910 Phase I Talazoparib A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors Completed
NCT01286987 Phase I Talazoparib Study of BMN 673, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors Completed
NCT02997163 Phase I Talazoparib An Open-Label Pharmacokinetics and Safety Study of Talazoparib Recruiting
NCT02537561 Phase I Talazoparib Gemcitabine + Cisplatin Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors Withdrawn
NCT02286687 Phase II Talazoparib Phase II Study of BMN 673 Recruiting
NCT01989546 Phase Ib/II Talazoparib Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations Recruiting
NCT02316834 Phase I Talazoparib POSITION: A PilOt Study of InducTion PARP InhibitiON in Ovarian Cancer Active, not recruiting
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) Completed
NCT03148795 Phase II Talazoparib A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Recruiting
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
NCT02358200 Phase I Paclitaxel + Carboplatin Talazoparib Study of BMN-673 With Carboplatin and Paclitaxel in Patients With Advanced BRCA-mutated Solid Tumor or Triple Negative Metastatic Breast Cancer Active, not recruiting
NCT03499353 Phase II Talazoparib Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer Recruiting
NCT03377556 Phase II Talazoparib Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer Recruiting
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
NCT03395197 Phase III Talazoparib Talazoparib + NHT vs. NHT Monotherapy in DDR+ mCRPC (TALAPRO-2) Recruiting
NCT02401347 Phase II Talazoparib Talazoparib Beyond BRCA (TBB) Trial Recruiting
NCT02921919 Phase II Talazoparib Open-Label Extension and Safety Study of Talazoparib Recruiting
NCT02317874 Phase I Paclitaxel + Carboplatin Talazoparib PARP Inhibitor BMN-673, Carboplatin, and Paclitaxel in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Recruiting