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 147 PD-L1/PD-1 antibody 117 | 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, in combination with Imjudo (tremelimumab) and platinum-based chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) without sensitizing EGFR or ALK mutations, in combination with etoposide and carboplatin or cisplatin in patients with extensive stage small cell lung cancer, in combination with cisplatin and gemcitabine in patients with locally advanced or metastatic biliary tract cancer, and in combination with Imjudo (tremelimumab) in adult patients with unresectable hepatocellular carcinoma (FDA.gov). |
| Olaparib | Lynparza | AZD2281|KU-0059436 | PARP Inhibitor (Pan) 30 | 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 (mCRPC) with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations who progressed following enzalutamide or abiraterone, in combination with abiraterone in patients with mCRPC harboring deleterious or suspected deleterious BRCA mutations, 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 |
|---|---|---|---|---|---|---|---|
| IDH1 mutant | cholangiocarcinoma | no benefit | Durvalumab + Olaparib | Phase II | Actionable | In a Phase II trial, combination treatment with Lynparza (olaparib) and Imfinzi (durvalumab) was well tolerated but failed to demonstrate efficacy in patients with advanced cholangiocarcinoma harboring mutations in IDH1 or IDH2, with no objective responses, a disease control rate of 30% (3/10, 3 stable disease), and a median progression-free survival of 1.97 months (J Clin Oncol 41, 2023 (suppl 16; abstr 4099); NCT03991832). | detail... |
| IDH1 mutant | high grade glioma | no benefit | Durvalumab + Olaparib | Phase II | Actionable | In a Phase II trial, combination therapy with Lynparza (olaparib) and Imfinzi (durvalumab) was well tolerated, but lacked antitumor activity in glioma patients with IDH1 (8/9) or IDH2 (1/9) mutations, and led to an objective response in one patient with glioblastoma, stable disease as per RECIST but clinical deterioration in two patients, and progressive disease in 6/9 (67%) patients, with a median progression free survival of 2.5 mo (J Clin Oncol 39, no. 15_suppl (May 20, 2021) abstr e14026); NCT03991832). | detail... |
| ATM inact mut | transitional cell carcinoma | predicted - sensitive | Durvalumab + Olaparib | Case Reports/Case Series | Actionable | In a Phase II trial (BAYOU), Lynparza (olaparib) and Imfinzi (durvalumab) improved median progression-free survival (5.6 vs 1.8 mo, HR 0.18) compared to Imfinzi (durvalumab) and placebo in a subgroup of patients with metastatic urothelial carcinoma harboring inactivating mutations in DNA damage repair genes (n=17), with 8.5% of the tumors harboring ATM inactivating mutations (PMID: 35737919; NCT03459846). | 35737919 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05568212 | Phase II | Durvalumab Durvalumab + Olaparib | Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab | Recruiting | ITA | 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 | NLD | GBR | BEL | 8 |
| 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 |
| NCT03334617 | Phase II | Danvatirsen + Durvalumab Durvalumab + Olaparib Cediranib + Durvalumab Durvalumab + Vistusertib Durvalumab + Trastuzumab deruxtecan Ceralasertib + 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) | Active, not recruiting | USA | FRA | ESP | DEU | CAN | AUT | 2 |
| NCT04336943 | Phase II | Durvalumab + Olaparib | Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load | Active, not 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 | NLD | GBR | FRA | 3 |
| NCT03167619 | Phase II | Durvalumab + Olaparib Olaparib | Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) (DORA) | Completed | 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) | Active, not recruiting | USA | ESP | DEU | CAN | BEL | AUS | 16 |
| NCT03801369 | Phase II | Durvalumab + Olaparib Ceralasertib Olaparib + Selumetinib Capivasertib + Olaparib | Olaparib in Combination With Either Durvalumab, Selumetinib, or Capivasertib or Ceralasertib Alone in Treating Patients With Metastatic Triple Negative Breast Cancer | Recruiting | USA | 0 |
| NCT05498155 | Phase II | Olaparib Durvalumab + Olaparib | Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer (OlympiaN) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS | 1 |
| NCT04644289 | Phase II | Olaparib Durvalumab + Olaparib | WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC (WoO) | Recruiting | DEU | 0 |
| NCT03544125 | Phase I | Durvalumab + Olaparib | Olaparib and Durvalumab in Treating Participants With Metastatic Triple Negative Breast Cancer | Completed | 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 | ESP | CAN | 4 |
| NCT04711824 | Phase Ib/II | Nab-paclitaxel Carboplatin + Gemcitabine Cisplatin Durvalumab + Olaparib Paclitaxel Capecitabine Gemcitabine Carboplatin Eribulin | Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases (SOLARA) | Recruiting | USA | 0 |
| NCT03741426 | Phase II | Durvalumab Cediranib Durvalumab + Olaparib Cediranib + Olaparib Olaparib | WIRE - Novel Treatments in Renal Cell Cancer (WIRE) | Recruiting | GBR | 0 |
| NCT03810105 | Phase II | Durvalumab + Olaparib | A Study of Olaparib and Durvalumab in Prostate Cancer | Terminated | USA | 0 |
| NCT03784014 | Phase III | Ceritinib Dabrafenib + Trametinib Capmatinib Durvalumab + Olaparib Nilotinib Futibatinib Trametinib Palbociclib Glasdegib Lapatinib | Molecular Profiling of Advanced Soft-tissue Sarcomas (MULTISARC) | Active, not recruiting | FRA | 0 |
| NCT03991832 | Phase II | Durvalumab + Olaparib | Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors (SOLID) | Recruiting | CAN | 0 |
| NCT03923270 | Phase I | Durvalumab + Tremelimumab Durvalumab Durvalumab + Olaparib | Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer | Active, not recruiting | USA | 0 |
| NCT05659914 | Phase II | Durvalumab + Olaparib | Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Pancreatic Cancer and DNA Damage Repair Genes Alterations | Recruiting | ESP | 0 |
| NCT05411094 | Phase I | Durvalumab + Olaparib | Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer | Suspended | USA | CAN | 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) | Active, not recruiting | CAN | 0 |
| 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 |
| NCT02546661 | Phase I | Danvatirsen + 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 | GBR | FRA | ESP | CAN | 0 |
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