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 Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer
- Conditions
- Head and Neck CancerCervical CancerCancer
- Interventions
- First Posted Date
- 2014-11-14
- Last Posted Date
- 2023-03-20
- Lead Sponsor
- Advaxis, Inc.
- Target Recruit Count
- 75
- Registration Number
- NCT02291055
- Locations
- 🇺🇸
Site, Milwaukee, Wisconsin, United States
Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
- Conditions
- Myelodysplastic Syndromes
- Interventions
- First Posted Date
- 2014-11-02
- Last Posted Date
- 2024-10-04
- Lead Sponsor
- Celgene
- Target Recruit Count
- 65
- Registration Number
- NCT02281084
- Locations
- 🇧🇪
Local Institution - 800, Liège, Belgium
🇵🇱Local Institution - 900, Warszawa, Poland
🇪🇸Local Institution - 300, Granada, Spain
Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Drug: Placebo
- First Posted Date
- 2014-10-24
- Last Posted Date
- 2024-10-31
- Lead Sponsor
- Canadian Cancer Trials Group
- Target Recruit Count
- 1415
- Registration Number
- NCT02273375
- Locations
- 🇨🇦
University Health Network, Toronto, Ontario, Canada
🇫🇷Hopital Avicenne, Bobigny, France
🇫🇷Paris - Institut Curie, Paris Cedex 5, France
Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer
- First Posted Date
- 2014-08-28
- Last Posted Date
- 2021-06-18
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 16
- Registration Number
- NCT02227667
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck
- Interventions
- First Posted Date
- 2014-08-04
- Last Posted Date
- 2020-09-29
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 112
- Registration Number
- NCT02207530
- Locations
- 🇬🇧
Research Site, Wirral, United Kingdom
Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma
- Conditions
- Part A and B: Advanced Solid MalignanciesPart C: Malignant Mesothelioma
- Interventions
- First Posted Date
- 2014-05-19
- Last Posted Date
- 2018-12-12
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 65
- Registration Number
- NCT02141347
- Locations
- 🇯🇵
Research Site, Yokohama-shi, Japan
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
- First Posted Date
- 2014-04-29
- Last Posted Date
- 2023-10-10
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 713
- Registration Number
- NCT02125461
- Locations
- 🇻🇳
Research Site, Ho Chi Minh, Vietnam
SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Interventions
- Drug: Standard maintenance for squamous NSCLC
- First Posted Date
- 2014-04-17
- Last Posted Date
- 2024-01-10
- Lead Sponsor
- UNICANCER
- Target Recruit Count
- 999
- Registration Number
- NCT02117167
- Locations
- 🇫🇷
Hôpital Avicenne, Bobigny, France
🇫🇷Institut Bergonié, Bordeaux, France
🇫🇷Institut Paoli Calmettes, Marseille, France
MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).
- First Posted Date
- 2014-03-14
- Last Posted Date
- 2022-04-04
- Lead Sponsor
- MedImmune LLC
- Target Recruit Count
- 56
- Registration Number
- NCT02088112
- Locations
- 🇰🇷
Research Site, Seoul, Korea, Republic of
A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
- First Posted Date
- 2014-03-14
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 446
- Registration Number
- NCT02087423
- Locations
- 🇬🇧
Research Site, Stoke-on-Trent, United Kingdom
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.