Durvalumab

Generic Name
Durvalumab
Brand Names
Imfinzi
Drug Type
Biotech
Chemical Formula
-
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 Durvalumab (Anti-PDL1) Plus Radiation Therapy for the Treatment of Solitary Bone Plasmacytoma

First Posted Date
2017-06-22
Last Posted Date
2018-08-03
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT03196401
Locations
🇺🇸

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Commack, Commack, New York, United States

🇺🇸

Memoral Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 3 locations

Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma

First Posted Date
2017-06-02
Last Posted Date
2024-02-12
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Target Recruit Count
39
Registration Number
NCT03174275
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

🇺🇸

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill, Chapel Hill, North Carolina, United States

Phase 1/2 Study of Combination Immunotherapy and Messenger Ribonucleic Acid (mRNA) Vaccine in Subjects With NSCLC

First Posted Date
2017-05-24
Last Posted Date
2022-10-10
Lead Sponsor
Ludwig Institute for Cancer Research
Target Recruit Count
61
Registration Number
NCT03164772
Locations
🇺🇸

Research Facility, Milwaukee, Wisconsin, United States

Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer

First Posted Date
2017-05-22
Last Posted Date
2022-08-25
Lead Sponsor
MedImmune LLC
Target Recruit Count
35
Registration Number
NCT03162224
Locations
🇺🇸

Research Site, Philadelphia, Pennsylvania, United States

Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma

First Posted Date
2017-05-19
Last Posted Date
2022-03-31
Lead Sponsor
University of Virginia
Target Recruit Count
148
Registration Number
NCT03161223
Locations
🇺🇸

University of Virginia, Charlottesville, Virginia, United States

Evaluating Immune Therapy, Duravalumab (MEDI4736) With Tremelimumab for Relapsed/Refractory Germ Cell Tumors

First Posted Date
2017-05-17
Last Posted Date
2024-12-04
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
30
Registration Number
NCT03158064
Locations
🇺🇸

Memorial Sloan Kettering Westchester, Harrison, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

Memorial Sloan Kettering Nassau, Uniondale, New York, United States

and more 4 locations

Radiation Therapy and Durvalumab, With or Without Tremelimumab, in Patients With Bladder Cancer

First Posted Date
2017-05-12
Last Posted Date
2017-10-19
Lead Sponsor
Terence Friedlander, MD
Registration Number
NCT03150836
Locations
🇺🇸

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC

First Posted Date
2017-05-05
Last Posted Date
2024-08-29
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
61
Registration Number
NCT03141359
Locations
🇺🇸

Levine Cancer Institute, Charlotte, North Carolina, United States

Durvalumab and Tremelimumab for Adjuvant Therapy of Resected NSCLC

First Posted Date
2017-04-26
Last Posted Date
2017-12-06
Lead Sponsor
Columbia University
Registration Number
NCT03130764
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