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

Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer

First Posted Date
2019-04-22
Last Posted Date
2024-11-28
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
25
Registration Number
NCT03923270
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC

First Posted Date
2019-04-02
Last Posted Date
2024-02-28
Lead Sponsor
Humanity & Health Medical Group Limited
Target Recruit Count
30
Registration Number
NCT03899428
Locations
🇭🇰

Humanity & Health Research Centre, Hong Kong, Hong Kong SAR, Hong Kong

Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

First Posted Date
2019-03-14
Last Posted Date
2022-05-31
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
17
Registration Number
NCT03874325
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-03-14
Last Posted Date
2024-11-27
Lead Sponsor
AstraZeneca
Target Recruit Count
810
Registration Number
NCT03875235
Locations
🇬🇧

Research Site, Sheffield, United Kingdom

Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer:

First Posted Date
2019-03-14
Last Posted Date
2024-12-20
Lead Sponsor
Jules Bordet Institute
Target Recruit Count
147
Registration Number
NCT03875573
Locations
🇧🇪

Universitaire Ziekenhuizen, Leuven, Belgium

🇧🇪

Institut Jules Bordet, Bruxelles, Belgium

🇧🇪

Cliniques Universitaires Saint-Luc, Bruxelles, Belgium

and more 4 locations

Pre-operAtive Non-Anthracycline Chemotherapy, Durvalumab +/- RAdiation Therapy in Triple Negative Breast Cancer

First Posted Date
2019-03-13
Last Posted Date
2021-08-25
Lead Sponsor
Cedars-Sinai Medical Center
Registration Number
NCT03872505
Locations
🇺🇸

Cedars Sinai Medical Center, Los Angeles, California, United States

Improve Checkpoint-blockade Response in Advanced Urothelial Cancer

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-03-12
Last Posted Date
2024-02-23
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
53
Registration Number
NCT03871036
Locations
🇳🇱

Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, Netherlands

A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2019-02-20
Last Posted Date
2024-06-12
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
60
Registration Number
NCT03847649
Locations
🇨🇦

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada

🇨🇦

Windsor Regional Cancer Centre, Windsor, Ontario, Canada

🇨🇦

BCCA - Vancouver, Vancouver, British Columbia, Canada

and more 9 locations

Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-02-20
Last Posted Date
2024-11-25
Lead Sponsor
AstraZeneca
Target Recruit Count
908
Registration Number
NCT03847428
Locations
🇻🇳

Research Site, Hochiminh, Vietnam

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