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 147 PD-L1/PD-1 antibody 117 | 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) 30 | 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 |
| NCT03330405 | Phase II | Avelumab + Talazoparib | Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors | Terminated | USA | GBR | CAN | BEL | AUS | 4 |
| NCT04068831 | Phase II | Avelumab + Talazoparib | Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma | Completed | USA | 0 |
| 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 | BEL | 2 |
| 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 |
| 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 |
| 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) | Active, not recruiting | USA | 0 |
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