Therapy Detail

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Therapy Name Durvalumab + Olaparib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Durvalumab Imfinzi MEDI4736 Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 69 Imfinzi (durvalumab) is a monoclonal antibody that binds to and inhibits PD-L1 (CD274), potentially resulting in increased immune response to tumors (PMID: 25943534, PMID: 28214651). Imfinzi (durvalumab) is FDA approved for use in patients with urothelial carcinoma and unresectable, stage III non-small cell lung cancer, and in combination with etoposide and carboplatin or cisplatin in patients with extensive stage small cell lung cancer (FDA.gov).
Olaparib Lynparza AZD2281|KU-0059436 PARP Inhibitor (Pan) 22 Lynparza (olaparib) binds to and inhibits PARP, resulting in inhibition of DNA repair and lethality in homologous-recombination deficient cells, and may be a sensitizing agent for chemotherapy and radiotherapy (PMID: 25028150, PMID: 24225019). Lynparza (olaparib) is FDA approved for treatment of ERBB2 (HER2)-negative breast cancer with deleterious or suspected deleterious germline BRCA mutations, ovarian cancer with deleterious or suspected deleterious germline BRCA mutations and received 3 or more prior therapies, metastatic pancreatic adenocarcinoma with deleterious or suspected deleterious germline BRCA mutations as a maintenance therapy, metastatic castration-resistant prostate cancer with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations who progressed following enzalutamide or abiraterone, as a maintenance therapy in recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and in epithelial ovarian, fallopian tube or primary peritoneal cancer with deleterious or suspected deleterious germline or somatic BRCA mutation, and in combination with Avastin (bevacizumab) as maintenance therapy in HDR defective epithelial ovarian, fallopian tube or primary peritoneal cancer as defined by deleterious or suspected deleterious BRCA mutation, and/or genomic instability (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown female reproductive organ cancer not applicable Durvalumab + Olaparib Phase I Actionable In a Phase I trial, the combination therapy of Imfinzi (durvalumab) and Lynparza (olaparib) resulted in an overall response rate of 17% (2/12) and disease control rate of 83% (10/12) in patients with female reproductive organ cancer (PMID: 28471727). 28471727
Unknown unknown prostate cancer not applicable Durvalumab + Olaparib Phase II Actionable In a Phase II trial, Imfinzi (durvalumab) plus Lynparza (olaparib) resulted in a decrease in PSA greater than or equal to 50% in 53% (9/17) of patients with metastatic castrate-resistant prostate cancer, with radiographic response in 4 of those 9, a median radiographic progression-free survival (PFS) of 16.1 mo., and a 12-mo. PFS probability of 83.3% in patients with mutations in DNA damage response (DDR) genes, compared to 36.4% in patients without DDR gene mutations (PMID: 30514390; NCT02484404). 30514390
Unknown unknown ovarian cancer not applicable Durvalumab + Olaparib Phase II Actionable In a Phase II trial, combination treatment with Imfinzi (durvalumab) and Lynparza (olaparib) did not meet the primary endpoint, but led to tumor immunomodulatory effects in patients with recurrent ovarian cancer and resulted in an overall response rate of 14% (5/35, all partial responses), a median progression-free survival of 3.9 months, and a disease control rate of 71% (25/35), including 12 patients that maintained a partial response or stable disease for more than 6 months (PMID: 32398324; NCT02484404). 32398324

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04538378 Phase II Durvalumab + Olaparib Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors Recruiting USA 0
NCT03851614 Phase II Cediranib + Durvalumab Durvalumab + Olaparib Basket Combination Study of Inhibitors of DNA Damage Response, Angiogenesis and Programmed Death Ligand 1 in Patients With Advanced Solid Tumors (DAPPER) Recruiting CAN 0
NCT03334617 Phase II AZD9150 + Durvalumab Durvalumab + Olaparib Cediranib + Durvalumab Durvalumab + Vistusertib Durvalumab + Trastuzumab deruxtecan AZD6738 + Durvalumab Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON) Recruiting USA | CAN 6
NCT03923270 Phase I Durvalumab + Tremelimumab Durvalumab Durvalumab + Olaparib Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer Recruiting USA 0
NCT03991832 Phase II Durvalumab + Olaparib Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors Recruiting CAN 0
NCT03775486 Phase II Durvalumab + Olaparib Cisplatin + Durvalumab + Pemetrexed Disodium Durvalumab Carboplatin + Durvalumab + Gemcitabine Carboplatin + Durvalumab + Pemetrexed Disodium Carboplatin + Durvalumab + Nab-paclitaxel Cisplatin + Durvalumab + Gemcitabine Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION) (ORION) Active, not recruiting USA 11
NCT03810105 Phase II Durvalumab + Olaparib A Study of Olaparib and Durvalumab in Prostate Cancer Recruiting USA 0
NCT03459846 Phase II Durvalumab + Olaparib Durvalumab A Phase II Study of Durvalumab and Olaparib Compared to Durvalumab in Patients With Advanced, Cisplatin Ineligible Bladder Cancer. (BAYOU) Active, not recruiting USA | CAN 5
NCT02546661 Phase I AZD9150 + Durvalumab Durvalumab + Selumetinib AZD4547 Durvalumab + Olaparib Durvalumab AZD4547 + Durvalumab Durvalumab + Vistusertib Adavosertib + Durvalumab Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer (BISCAY) Active, not recruiting USA | CAN 3
NCT04336943 Phase II Durvalumab + Olaparib Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load Recruiting USA 0
NCT02734004 Phase Ib/II Durvalumab + Olaparib Bevacizumab + Durvalumab + Olaparib A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (MEDIOLA) Active, not recruiting USA 6
NCT02484404 Phase Ib/II Cediranib + Durvalumab Durvalumab + Olaparib Phase 1 and 2 Study of MEDI4736 in Combination With Olaparib or Cediranib for Advanced Solid Tumors and Recurrent Ovarian Cancer Recruiting USA 0
NCT03544125 Phase I Durvalumab + Olaparib Olaparib and Durvalumab in Treating Participants With Metastatic Triple Negative Breast Cancer Completed USA 0
NCT03167619 Phase II Durvalumab + Olaparib Olaparib Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) (DORA) Active, not recruiting USA 0
NCT03801369 Phase II Durvalumab + Olaparib Olaparib and Durvalumab to Treat Patients With Metastatic Triple Negative Breast Cancer Recruiting USA 0
NCT04269200 Phase III Durvalumab Durvalumab + Olaparib Carboplatin + Durvalumab + Paclitaxel Carboplatin + Durvalumab + Olaparib + Paclitaxel Carboplatin + Paclitaxel Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer (DUO-E) Recruiting USA | CAN 19


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