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DRUG:

Imfinzi (durvalumab)

i
Other names: MEDI4736, MEDI-4736, MEDI 4736
Company:
AstraZeneca
Drug class:
PD-L1 inhibitor
Related drugs:
1d
Durvalumab and Tremelimumab With Platinum-based Chemotherapy in Intrahepatic Cholangiocarcinoma (ICC) (clinicaltrials.gov)
P1/2, N=1, Completed, University of Alabama at Birmingham | Active, not recruiting --> Completed | N=20 --> 1 | Trial completion date: Dec 2024 --> May 2024
Trial completion • Enrollment change • Trial completion date • IO biomarker
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
5d
PIONeeR: Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance (clinicaltrials.gov)
P2, N=114, Active, not recruiting, Assistance Publique Hopitaux De Marseille | Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Oct 2023 --> Oct 2024
Enrollment closed • Trial completion date • Trial primary completion date • Metastases • Immuno-oncology
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • ALK rearrangement • ROS1 rearrangement
|
Imfinzi (durvalumab) • docetaxel • Orpathys (savolitinib) • ceralasertib (AZD6738) • oleclumab (MEDI9447) • monalizumab (IPH2201)
7d
New P2 trial • IO biomarker
|
PD-L1 (Programmed death ligand 1) • RB1 (RB Transcriptional Corepressor 1)
|
PD-L1 expression • RB1 mutation
|
cisplatin • carboplatin • Imfinzi (durvalumab) • etoposide IV
13d
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) (clinicaltrials.gov)
P2, N=531, Recruiting, AstraZeneca | Trial completion date: Mar 2025 --> Aug 2026 | Trial primary completion date: Mar 2025 --> Aug 2026
Trial completion date • Trial primary completion date • Combination therapy • Pan tumor • Metastases
|
Avastin (bevacizumab) • carboplatin • Imfinzi (durvalumab) • 5-fluorouracil • capecitabine • leucovorin calcium • datopotamab deruxtecan (DS-1062a) • saruparib (AZD5305) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
14d
ESR-22-21719: Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
P2, N=28, Recruiting, Georgetown University | Initiation date: Mar 2024 --> Jun 2024
Trial initiation date • Combination therapy
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
14d
Journal • Real-world evidence • Real-world
|
PD-L1 (Programmed death ligand 1)
|
Imfinzi (durvalumab)
14d
Inflammatory pathways confer resistance to chemoradiotherapy in anal squamous cell carcinoma. (PubMed, NPJ Precis Oncol)
Inflammatory pathways in tissue in line with elevated levels of regulatory T-cells and CXCL2 in peripheral blood are associated with resistance to CRT. To counteract this resistance mechanism, the RADIANCE randomized phase-2 trial currently tests the addition of the immune checkpoint inhibitor durvalumab to standard CRT in locally advanced ASCC.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • IFNA1 (Interferon Alpha 1)
|
PD-L1 expression • CD4 expression
|
Imfinzi (durvalumab)
14d
BEGONIA: A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P1/2, N=240, Recruiting, AstraZeneca | Trial completion date: Aug 2024 --> Nov 2024 | Trial primary completion date: Aug 2024 --> Nov 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • HER-2 expression • PD-L1 expression + HER-2 overexpression
|
Imfinzi (durvalumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • Truqap (capivasertib) • datopotamab deruxtecan (DS-1062a) • oleclumab (MEDI9447)
16d
The emerging therapies are reshaping the first-line treatment for advanced hepatocellular carcinoma: a systematic review and network meta-analysis. (PubMed, Therap Adv Gastroenterol)
In the whole-population network meta-analysis, the newly first-line tremelimumab plus durvalumab (Tre + Du) was found to be comparable with atezolizumab plus bevacizumab (Atezo + Beva) in providing the best overall survival (OS) benefit [hazard ratio (HR) 1.35, 95% confidence interval (CI): 0.93-1.92]. Concerning OS benefits, sintilimab plus bevacizumab biosimilar (Sint + Beva), camrelizumab plus rivoceranib (Camre + Rivo), and lenvatinib plus pembrolizumab (Lenva + Pemb) appear to exhibit similar effects to Tre + Du and Atezo + Beva...With lower incidence rates of treatment-related adverse events and non-inferior efficacy compared to sorafenib, ICI monotherapies should be prioritized as a first-line treatment approach for patients who are not suitable candidates for ICI-combined therapies. PROSPERO, CRD42022288172.
Clinical • Retrospective data • Review • Journal • Metastases
|
AFP (Alpha-fetoprotein)
|
Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • sorafenib • Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Imjudo (tremelimumab)
16d
SADDRIN-1: Sarcomas and DDR-Inhibition; a Combined Modality Study (clinicaltrials.gov)
P1, N=30, Recruiting, The Netherlands Cancer Institute | N=15 --> 30 | Trial completion date: Mar 2024 --> Jul 2028 | Trial primary completion date: Mar 2024 --> Mar 2026
Enrollment change • Trial completion date • Trial primary completion date
|
Imfinzi (durvalumab) • AZD1390
16d
Abequolixron (RGX-104) and Durvalumab in Lung Cancer (clinicaltrials.gov)
P1, N=24, Recruiting, UNC Lineberger Comprehensive Cancer Center | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
carboplatin • Imfinzi (durvalumab) • albumin-bound paclitaxel • pemetrexed • abequolixron (RGX-104)
16d
FRAIL-IMMUNE (GORTEC 2018-03) - Combination of Durvalumab With Carboplatin/Paclitaxel (clinicaltrials.gov)
P2, N=104, Completed, Centre Leon Berard | Recruiting --> Completed | Trial completion date: Aug 2024 --> Mar 2024
Trial completion • Trial completion date • IO biomarker • Metastases
|
CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • CD38 (CD38 Molecule) • CD4 (CD4 Molecule) • FOXP3 (Forkhead Box P3)
|
PD-L1 expression
|
carboplatin • Imfinzi (durvalumab) • paclitaxel
18d
Real-world treatment patterns and clinical outcomes in patients with stage III NSCLC in Korea: The KINDLE study. (PubMed, Cancer Med)
This study revealed the heterogeneity of treatment patterns and survival outcomes in patients with stage III NSCLC before durvalumab consolidation came into clinical practice. There is an unmet need for patients who are not eligible for surgery as an initial therapy. Novel therapeutic approaches are highly warranted to improve clinical outcomes.
Clinical data • Journal • HEOR • Real-world evidence • PD(L)-1 Biomarker • IO biomarker • Real-world
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • EGFR mutation
|
Imfinzi (durvalumab)
19d
Recent Advances in Systemic Therapy for Advanced Intrahepatic Cholangiocarcinoma. (PubMed, Liver Cancer)
The addition of durvalumab to a gemcitabine plus cisplatin regimen has significantly improved overall survival in the phase 3 TOPAZ-1 trial and is currently recommended as a standard first-line treatment. The phase 3 ABC-06 and phase 2b NIFTY trials have shown the benefit of second-line fluoropyrimidine plus oxaliplatin, and fluoropyrimidine plus nanoliposomal irinotecan, respectively...However, most patients eventually show resistance to the treatment, and tumor progression occurs within a year. Indeed, there should be further efforts to improve the outcomes of patients with advanced IHCCA.
Review • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
BRAF mutation • HER-2 amplification • HER-2 mutation • IDH1 mutation • FGFR2 mutation • FGFR2 rearrangement
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • oxaliplatin • Onivyde (nanoliposomal irinotecan)
19d
Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer (clinicaltrials.gov)
P2, N=71, Active, not recruiting, Do-Youn Oh | Recruiting --> Active, not recruiting | Trial completion date: Nov 2021 --> Dec 2024 | Trial primary completion date: Nov 2021 --> Dec 2024
Enrollment closed • Trial completion date • Trial primary completion date
|
Imfinzi (durvalumab) • gemcitabine
19d
New P2 trial • Combination therapy
|
cisplatin • Imfinzi (durvalumab) • gemcitabine
19d
ESR-15-11655: Biomarker-oriented Study of Durvalumab (MEDI4736) in Combination With Olaparib and Paclitaxel in Gastric Cancer (clinicaltrials.gov)
P2, N=40, Active, not recruiting, Do-Youn Oh | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy
|
Lynparza (olaparib) • Imfinzi (durvalumab) • paclitaxel
19d
DDR-Umbrella Study of DDR Targeting Agents in Advanced Biliary Tract Cancer (clinicaltrials.gov)
P2, N=74, Active, not recruiting, Seoul National University Hospital | Trial primary completion date: Dec 2023 --> Dec 2024
Trial primary completion date • Metastases
|
Lynparza (olaparib) • Imfinzi (durvalumab) • ceralasertib (AZD6738)
19d
AZD6738 Plus Durvalumab in Biliary Tract Cancer (clinicaltrials.gov)
P2, N=26, Recruiting, Seoul National University Hospital | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
|
Imfinzi (durvalumab) • ceralasertib (AZD6738)
19d
Durvalumab Followed by Chemoradiation and Consolidation Durvalumab for Stage III Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=10, Active, not recruiting, Rachel Sanborn | Trial completion date: Nov 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Jun 2023
Trial completion date • Trial primary completion date
|
cisplatin • carboplatin • Imfinzi (durvalumab) • pemetrexed • etoposide IV
19d
Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer (clinicaltrials.gov)
P2, N=31, Active, not recruiting, Seoul National University Hospital | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date • Combination therapy
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
21d
Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC (clinicaltrials.gov)
P3, N=48, Recruiting, Maximilian Diehn | Trial completion date: Mar 2026 --> Apr 2028 | Trial primary completion date: Mar 2024 --> Apr 2026
Trial completion date • Trial primary completion date
|
cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • Imjudo (tremelimumab) • pemetrexed
22d
Evaluation of tumor response to immune checkpoint inhibitors by a 3D immunotumoroid model. (PubMed, Front Immunol)
Immunotumoroid response to ICIs (nivolumab, pembrolizumab, and durvalumab) and chemotherapy (cisplatin, gemcitabine, and paclitaxel) was monitored in real-time with Cytotox Red staining in an Incucyte device, and the immunotumoroid response was compared to retrospective clinical drug responses. This model could enable valuable insights into the complex interactions between cancer cells, the immune system, and the microenvironment. This is a feasibility study on a small number of cases, and additional studies with larger case numbers are required including correlation with clinical response.
Retrospective data • Journal • Checkpoint inhibition
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel
22d
Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI (clinicaltrials.gov)
P=N/A, N=200, Recruiting, AstraZeneca | Trial completion date: Nov 2025 --> Jul 2026 | Trial primary completion date: Nov 2025 --> Jul 2026
Trial completion date • Trial primary completion date
|
Imfinzi (durvalumab)
22d
PACIFIC-R: First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy (clinicaltrials.gov)
P=N/A, N=1156, Active, not recruiting, AstraZeneca | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
Trial completion date • Trial primary completion date • Real-world evidence • Real-world
|
Imfinzi (durvalumab)
22d
Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study (clinicaltrials.gov)
P=N/A, N=300, Recruiting, AstraZeneca | Trial completion date: Oct 2024 --> Dec 2026 | Trial primary completion date: Oct 2024 --> Dec 2026
Trial completion date • Trial primary completion date
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
23d
Efficacy of consolidation of immune checkpoint inhibitor after chemoradiation for unresectable, locally advanced PD‑L1 negative non‑small cell lung cancer: A systematic review and meta‑analysis. (PubMed, Oncol Lett)
Chemoradiotherapy (CRT) followed by consolidation of immune checkpoint inhibitors (ICIs), such as durvalumab or pembrolizumab, for patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) with tumor PD-L1 expression <1% remains a topic of controversy. The findings of the present study highlighted that the benefits of CRT followed by consolidation of ICIs were higher compared with CRT alone in patients with unresectable, locally advanced NSCLC and PD-L1 expression <1%. Consolidation of ICIs after CRT would provide greater benefits for locally advanced NSCLC patients with PD-L1 expression ≥1% compared with those with PD-L1 expression <1%.
Retrospective data • Review • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PD-L1 negative
|
Keytruda (pembrolizumab) • Imfinzi (durvalumab)
23d
SAKK 16/14: Anti-PD-L1 in Stage IIIA(N2) Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
P2, N=68, Completed, Swiss Group for Clinical Cancer Research | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Mar 2024
Trial completion • Trial completion date
|
Imfinzi (durvalumab) • docetaxel
26d
EMERALD-2: Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment (clinicaltrials.gov)
P3, N=908, Active, not recruiting, AstraZeneca | Trial completion date: Aug 2025 --> May 2027 | Trial primary completion date: Aug 2024 --> May 2026
Trial completion date • Trial primary completion date • Combination therapy
|
Avastin (bevacizumab) • Imfinzi (durvalumab)
26d
RaDD: A Trial of Radiotherapy and Durvalumab in DLBCL and FL (clinicaltrials.gov)
P1, N=34, Completed, Austin Health | Active, not recruiting --> Completed
Trial completion
|
CD20 positive
|
Imfinzi (durvalumab)
26d
Trial completion date • Trial primary completion date • Metastases
|
Lynparza (olaparib) • Imfinzi (durvalumab) • Truqap (capivasertib) • Recentin (cediranib)
27d
CheckRad-CD8: Radiotherapy With Double Checkpoint Blockade of Locally Advanced HNSCC (clinicaltrials.gov)
P2, N=120, Completed, University of Erlangen-Nürnberg Medical School | Active, not recruiting --> Completed
Trial completion • Checkpoint inhibition • Checkpoint block • Metastases
|
CD8 (cluster of differentiation 8)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
28d
Promising immunotherapy targets: TIM3, LAG3, and TIGIT joined the party. (PubMed, Mol Ther Oncol)
Currently, seven ICIs, namely ipilimumab (anti-cytotoxic T lymphocyte-associated protein 4 [CTLA4]), pembrolizumab, nivolumab (anti-programmed cell death protein 1 [PD-1]), atezolizumab, avelumab, durvalumab, and cemiplimab (anti-PD-L1), have been approved for various cancer types. Consequently, ongoing studies are evaluating the next generation of ICIs, such as lymphocyte activation gene-3 (LAG3), T cell immunoglobulin and mucin-domain containing 3 (TIM3), and T cell immunoglobulin and ITIM domain (TIGIT). Our review provides a summary of clinical trials evaluating these novel immune checkpoints in cancer treatment.
Review • Journal
|
LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Libtayo (cemiplimab-rwlc)
28d
PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC (clinicaltrials.gov)
P2, N=110, Active, not recruiting, TheraOp | Not yet recruiting --> Active, not recruiting | Initiation date: Nov 2023 --> Feb 2024
Enrollment closed • Trial initiation date • IO biomarker • FDG PET • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Imfinzi (durvalumab)
29d
MATTERHORN: Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer (clinicaltrials.gov)
P3, N=958, Active, not recruiting, AstraZeneca | Trial completion date: Feb 2025 --> Sep 2027 | Trial primary completion date: Feb 2025 --> Oct 2025
Trial completion date • Trial primary completion date
|
Imfinzi (durvalumab) • docetaxel • oxaliplatin
29d
DUMELEP: Durvalumab/Tremelimumab in Neoadjuvant and Adjuvant Setting in Patients With HCC Treated by Electroporation Ablation (clinicaltrials.gov)
P2, N=30, Recruiting, Assistance Publique - Hôpitaux de Paris | Not yet recruiting --> Recruiting | Trial completion date: Jan 2026 --> Sep 2027 | Initiation date: Dec 2023 --> Mar 2024 | Trial primary completion date: Feb 2025 --> Sep 2026
Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
|
FLT4 (Fms-related tyrosine kinase 4) • VEGFC (Vascular Endothelial Growth Factor C)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
1m
NOVOCURE: Tumor Treating Fields for Locally Advanced NSCLC (clinicaltrials.gov)
P1, N=30, Recruiting, University of Utah | Suspended --> Recruiting | Initiation date: Nov 2023 --> Apr 2024
Enrollment open • Trial initiation date • Metastases
|
carboplatin • Imfinzi (durvalumab) • albumin-bound paclitaxel
1m
Enrollment change • Combination therapy
|
CD4 (CD4 Molecule)
|
cisplatin • carboplatin • Imfinzi (durvalumab) • pemetrexed • Pemfexy (pemetrexed) • methoxyamine (TRC102)
1m
P3 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
1m
Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer (SWOG-Spring 2024)
Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic, or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy. Summary Statement This study activated on 10/30/2023. As of December 31, 2023, there had been five patients registered to MammaPrint screening step, all of whom did not to go on to randomization due to ineligible MammaPrint status.
P3 data • Clinical
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HR positive • HER-2 negative • PGR positive • EGFR positive
|
MammaPrint
|
Imfinzi (durvalumab) • paclitaxel • doxorubicin hydrochloride
1m
Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer (clinicaltrials.gov)
P1, N=18, Suspended, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
CD4 (CD4 Molecule)
|
Lynparza (olaparib) • Imfinzi (durvalumab)