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

Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2022-05-16
Last Posted Date
2024-10-14
Lead Sponsor
AstraZeneca
Target Recruit Count
47
Registration Number
NCT05374603
Locations
🇨🇳

Research Site, Zhengzhou, China

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

First Posted Date
2022-05-04
Last Posted Date
2024-07-25
Lead Sponsor
Amgen
Target Recruit Count
340
Registration Number
NCT05361395
Locations
🇺🇸

University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Christiana Care Health Services, Newark, Delaware, United States

🇺🇸

Henry Ford Health System, Detroit, Michigan, United States

and more 41 locations

Himalaya Early Access Program

First Posted Date
2022-04-26
Last Posted Date
2022-12-14
Lead Sponsor
AstraZeneca
Registration Number
NCT05345678
Locations
🇺🇸

Research Site, Morgantown, West Virginia, United States

An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC

First Posted Date
2022-04-14
Last Posted Date
2022-04-14
Lead Sponsor
Chinese PLA General Hospital
Target Recruit Count
65
Registration Number
NCT05327582
Locations
🇨🇳

Biotherapeutic Department of Chinese PLA General Hospital, Beijing, Beijing, China

Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

First Posted Date
2022-03-31
Last Posted Date
2024-07-29
Lead Sponsor
AstraZeneca
Target Recruit Count
725
Registration Number
NCT05301842
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab

Phase 3
Conditions
Interventions
First Posted Date
2022-03-31
Last Posted Date
2024-12-18
Lead Sponsor
AstraZeneca
Target Recruit Count
61
Registration Number
NCT05303532
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)

First Posted Date
2022-03-28
Last Posted Date
2024-12-19
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
784
Registration Number
NCT05298423
Locations
🇨🇳

Tianjin Cancer Hospital ( Site 0329), Tianjin, Tianjin, China

🇨🇳

Hangzhou Cancer Hospital-Medical Oncology ( Site 0302), Hangzhou, Zhejiang, China

🇨🇳

The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301), Hangzhou, Zhejiang, China

and more 157 locations

Neoadjuvant Immunotherapy With Durvalumab (MEDI4736) in Non-Surgical Early Stage or Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Followed by Radical Radiotherapy or Chemoradiotherapy

First Posted Date
2022-03-04
Last Posted Date
2022-03-04
Lead Sponsor
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Target Recruit Count
30
Registration Number
NCT05267392
Locations
🇵🇹

Instituto Português de Oncologia do Porto FG, EPE (IPO-Porto), Porto, Portugal

Durvalumab (MEDI4736) Plus Platinum-based Chemotherapy in Advanced LCNEC: a Pilot Phase II Study

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2022-03-02
Last Posted Date
2022-03-02
Lead Sponsor
Elizabeth Dudnik
Target Recruit Count
22
Registration Number
NCT05262985
Locations
🇮🇱

Assuta MC, Tel Aviv, Israel

Refining Adjuvant Treatment in Endometrial Cancer Based on Molecular Features

First Posted Date
2022-02-24
Last Posted Date
2024-11-28
Lead Sponsor
Leiden University Medical Center
Target Recruit Count
1615
Registration Number
NCT05255653
Locations
🇨🇦

The POLEmut-BLUE trial: Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada

🇳🇱

Medisch Spectrum Twente, Enschede, Netherlands

🇳🇱

The MMRd-GREEN trial: Leiden University Medical Center, Leiden, Netherlands

and more 11 locations
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