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 149 PD-L1/PD-1 antibody 122 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, unresectable, stage III non-small cell lung cancer, and limited-stage 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 platinum-based chemotherapy as neoadjuvant therapy followed by surgery and adjuvant Imfinzi (durvalumab) in patients with resectable non-small cell lung cancer, 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, in combination with Imjudo (tremelimumab) in adult patients with unresectable hepatocellular carcinoma, and in combination with carboplatin plus paclitaxel followed by single-agent Imfinzi (durvalumab) in adult patients with mismatch repair deficient endometrial cancer (FDA.gov).
Olaparib Lynparza AZD2281|KU-0059436 PARP Inhibitor (Pan) 31 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
ATM inact mut invasive ductal carcinoma predicted - sensitive Durvalumab + Olaparib Case Reports/Case Series Actionable In a Phase II trial, treatment with the combination of Lynparza (olaparib) and Imfinzi (durvalumab) resulted in a partial response in a patient with invasive ductal carcinoma harboring an ATM inactivating mutation (PMID: 37365284). 37365284
ATM inact mut Advanced Solid Tumor predicted - sensitive Durvalumab + Olaparib Case Reports/Case Series Actionable In a Phase II trial, treatment with the combination of Lynparza (olaparib) and Imfinzi (durvalumab) led to a 6-month progression-free survival (PFS) rate of 35%, objective tumor response (OTR) rate of 19% (3/16, all partial responses (PR)), and median PFS of 3.7mo in advanced solid tumor patients harboring BRCA1/2 mutations and a 6-month PFS rate of 38%, OTR rate of 9% (3/32, 1 complete, 2 PR), and median PFS of 3.6mo with other HRR alterations, including ATM (n=9) and CHEK2 (n=3) (PMID: 37365284). 37365284
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 neuroendocrine carcinoma predicted - sensitive Durvalumab + Olaparib Case Reports/Case Series Actionable In a Phase II trial, treatment with the combination of Lynparza (olaparib) and Imfinzi (durvalumab) resulted in a partial response in a patient with a neuroendocrine carcinoma harboring an ATM inactivating mutation (PMID: 37365284). 37365284
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
NCT05659914 Phase II Durvalumab + Olaparib Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Pancreatic Cancer and DNA Damage Repair Genes Alterations Active, not 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 Recruiting USA | CAN 0
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 | POL | NLD | HUN | GBR | BEL 6
NCT04644289 Phase II Olaparib Durvalumab + Olaparib WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC (WoO) Recruiting DEU 0
NCT03741426 Phase II Durvalumab Cediranib Durvalumab + Olaparib Cediranib + Olaparib Olaparib WIRE - Novel Treatments in Renal Cell Cancer (WIRE) Recruiting GBR 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 | ISR | GBR | FRA | CHE 1
NCT06441747 Phase II Durvalumab + Olaparib Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP Inhibitor) in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab (BIL-PPP) Not yet recruiting AUS 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 | POL | LTU | ISR | HUN | GRC | EST | ESP | DEU | CAN | BRA | BEL | AUS 9
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
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 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
NCT05498155 Phase II Olaparib Durvalumab + Olaparib Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer (OlympiaN) Active, not recruiting USA | ITA | ISR | GBR | ESP | DEU | BEL | AUT | AUS 0
NCT03991832 Phase II Durvalumab + Olaparib Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors (SOLID) Recruiting CAN 0
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
NCT03544125 Phase I Durvalumab + Olaparib Olaparib and Durvalumab in Treating Participants With Metastatic Triple Negative Breast Cancer Completed 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 | ISR | FRA | ESP | DEU | CAN | AUT 1
NCT04742075 Phase II Olaparib Durvalumab + Olaparib Durvalumab + Olaparib + UV1 Telomerase peptide vaccine Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer (DOVACC) Recruiting DNK 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
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
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
NCT02546661 Phase I Danvatirsen + Durvalumab Durvalumab + Selumetinib Fexagratinib Durvalumab + Olaparib Durvalumab Durvalumab + Fexagratinib 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
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
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
NCT03810105 Phase II Durvalumab + Olaparib A Study of Olaparib and Durvalumab in Prostate Cancer Terminated 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) Completed USA 0


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