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

Durvalumab + Tremelimumab ± Paclitaxel in Advanced BTC After Platinum Chemotherapy.

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-10-12
Last Posted Date
2024-01-05
Lead Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Target Recruit Count
106
Registration Number
NCT03704480
Locations
🇫🇷

Hôpital Saint Eloi, Montpellier, France

🇫🇷

CHU Henri Mondor, Créteil, France

🇫🇷

CHU Dijon, Dijon, France

and more 25 locations

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-10-11
Last Posted Date
2024-11-06
Lead Sponsor
AstraZeneca
Target Recruit Count
730
Registration Number
NCT03703297
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Durvalumab Plus Tremelimumab With Concurrent Radiotherapy for Localized Muscle Invasive Bladder Cancer Treated With a Selective Bladder Preservation Approach

First Posted Date
2018-10-10
Last Posted Date
2024-12-05
Lead Sponsor
Spanish Oncology Genito-Urinary Group
Target Recruit Count
32
Registration Number
NCT03702179
Locations
🇪🇸

Instituto Catalán de Oncología Badalona, Badalona, Barcelona, Spain

🇪🇸

Hospital Universitario 12 de Octubre, Madrid, Spain

🇪🇸

Centro Oncológico de Galicia, La Coruña, Spain

and more 4 locations

Concurrent Neoadjuvant Chemoradiotherapy Plus Durvalumab (MEDI4736) in Resectable Stage III NSCLC

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2018-10-03
Last Posted Date
2019-09-26
Lead Sponsor
Yonsei University
Target Recruit Count
39
Registration Number
NCT03694236
Locations
🇰🇷

Severance Hospital, Seoul, Korea, Republic of

A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-10-02
Last Posted Date
2024-06-18
Lead Sponsor
AstraZeneca
Target Recruit Count
117
Registration Number
NCT03693300
Locations
🇬🇧

Research Site, Stoke on Trent, United Kingdom

Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

First Posted Date
2018-10-02
Last Posted Date
2023-12-08
Lead Sponsor
Trisha Wise-Draper
Target Recruit Count
36
Registration Number
NCT03691714
Locations
🇺🇸

UC Health, Cincinnati, Ohio, United States

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