Therapy Detail

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Therapy Name Avelumab + Talazoparib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Avelumab Bavencio MSB0010718C Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 Bavencio (avelumab) is a monoclonal antibody binds to human immunosuppressive ligand programmed death-ligand 1 (PD-L1, CD274) and blocks protein signaling, resulting in immune regulation and antitumor immunity (PMID: 26014098). Bavencio (avelumab) is FDA-approved for use in adult and pediatric patients of 12 years or older with metastatic Merkel cell carcinoma, as maintenance therapy in locally advanced or metastatic urothelial carcinoma (UC), in locally advanced or metastatic UC that progressed following chemotherapy, and in combination with axitinib as first-line therapy in advanced renal cell carcinoma (FDA.gov).
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
ATM inact mut Advanced Solid Tumor no benefit Avelumab + Talazoparib Phase II Actionable In a Phase II trial (JAVELIN), Talzenna (talazoparib) and Bavencio (avelumab) combination therapy did not meet the prespecified futility requirement with a confirmed objective response rate of 4.9% (2/41, 2 partial responses) in patients with advanced solid tumors harboring ATM inactivating mutations, and subsequently, enrollment to the cohort was discontinued (PMID: 36394867; NCT03565991). 36394867

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04678362 Phase II Avelumab + Talazoparib TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma (TALASUR) Recruiting FRA 0
NCT02912572 Phase II Avelumab + Talazoparib Avelumab Avelumab + Axitinib 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 USA 0
NCT03330405 Phase II Avelumab + Talazoparib Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors Terminated USA | HUN | GBR | DNK | CAN | BEL | AUS 2
NCT03565991 Phase II Avelumab + Talazoparib Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors Terminated USA | NLD | ITA | GBR | FRA | ESP | DNK | BEL 1
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
NCT04173507 Phase II Avelumab + Talazoparib Combination Treatment (Talazoparib Plus Avelumab) for Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer With STK11 Gene Mutation (A LUNG-MAP Treatment Trial) Completed USA 0
NCT04068831 Phase II Avelumab + Talazoparib Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma Completed USA 0


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