Durvalumab
- Generic Name
- Durvalumab
- Brand Names
- Imfinzi
- Drug Type
- Biotech
- CAS Number
- 1428935-60-7
- Unique Ingredient Identifier
- 28X28X9OKV
- Background
Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells.
Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma. In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy. On March 27, 2020, durvalumab was approved by the FDA for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
- Indication
Durvalumab is indicated for the treatment of adults with the following conditions:
- Associated Conditions
- Extensive-stage Small Cell Lung Cancer (SCLC), Locally Advanced Biliary Tract Cancer, Metastatic Biliary Tract Cancer, Metastatic Non-Small Cell Lung Cancer, Unresectable Hepatocellular Carcinoma (HCC), Unresectable Stage III Non-small Cell Lung Cancer, Unresectable, locally advanced PD-L1 positive Lung Cancer Non-Small Cell Cancer (NSCLC)
- Associated Therapies
- First Line Chemotherapy
A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer
- Conditions
- NSCLCNon-small Cell Lung CancerLung Cancer
- Interventions
- First Posted Date
- 2013-12-04
- Last Posted Date
- 2019-10-31
- Lead Sponsor
- MedImmune LLC
- Target Recruit Count
- 459
- Registration Number
- NCT02000947
- Locations
- 🇬🇧
Research Site, Manchester, United Kingdom
Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer
- Conditions
- Stage II Non-Small Cell Lung Cancer AJCC v7Stage IIA Non-Small Cell Lung Carcinoma AJCC v7Stage IIB Non-Small Cell Lung Carcinoma AJCC v7Stage III Non-Small Cell Lung Cancer AJCC v7Stage IIIA Non-Small Cell Lung Cancer AJCC v7Stage IIIB Non-Small Cell Lung Cancer AJCC v7
- Interventions
- Radiation: Photon Beam Radiation TherapyRadiation: Proton Beam Radiation TherapyOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- First Posted Date
- 2013-11-25
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- Radiation Therapy Oncology Group
- Target Recruit Count
- 330
- Registration Number
- NCT01993810
- Locations
- 🇺🇸
MD Anderson Regional Care Center-Sugar Land, Sugar Land, Texas, United States
🇺🇸University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab
- Conditions
- Breast CancerRenal Cell CarcinomaOvarian CancerCervical CancerColorectal Cancer
- Interventions
- First Posted Date
- 2013-11-05
- Last Posted Date
- 2022-10-12
- Lead Sponsor
- Ludwig Institute for Cancer Research
- Target Recruit Count
- 104
- Registration Number
- NCT01975831
- Locations
- 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸University of Virginia Division of Hematology and Oncology, Charlottesville, Virginia, United States
A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours
- First Posted Date
- 2013-09-10
- Last Posted Date
- 2021-03-12
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 269
- Registration Number
- NCT01938612
- Locations
- 🇨🇳
Research Site, Taoyuan, Taiwan
A Phase 1/2 Study to Evaluate MEDI4736
- First Posted Date
- 2012-09-26
- Last Posted Date
- 2021-05-13
- Lead Sponsor
- MedImmune LLC
- Target Recruit Count
- 1022
- Registration Number
- NCT01693562
- Locations
- 🇬🇧
Research Site, Sutton, United Kingdom
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
- Conditions
- HER2-negative Breast CancerHormone Receptor Positive TumorAngiosarcomaTNBC - Triple-Negative Breast CancerBreast NeoplasmsBreast TumorsHER2-positive Breast CancerHormone Receptor Negative TumorBreast CancerEarly-stage Breast Cancer
- Interventions
- Drug: Standard TherapyDrug: AMG 386 with or without TrastuzumabDrug: AMG 479 (Ganitumab) plus MetforminDrug: SYD985 ([vic-]trastuzumab duocarmazine)Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumabDrug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumabDrug: Datopotamab deruxtecan + DurvalumabDrug: Rilvegostomig + TDXdDrug: AMG 386 and Trastuzumab
- First Posted Date
- 2010-01-05
- Last Posted Date
- 2024-10-22
- Lead Sponsor
- QuantumLeap Healthcare Collaborative
- Target Recruit Count
- 5000
- Registration Number
- NCT01042379
- Locations
- 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸University of Texas, Southwestern Medical Center, Dallas, Texas, United States
🇺🇸University of Kansas, Westwood, Kansas, United States
Drug Development Updates
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