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

Clinical Trials

MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Subjects With Relapsed/Refractory DLBCL (D4190C00023)

Phase 1

Completed

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Drug: MEDI4736
Drug: AZD9150
Drug: tremelimumab

First Posted Date: 2015-09-15

Last Posted Date: 2019-02-27

Lead Sponsor: MedImmune LLC

Target Recruit Count: 32

Registration Number: NCT02549651

Locations: 🇬🇧
Research Site, Leicester, United Kingdom

Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

Phase 1

Active, not recruiting

Conditions: Muscle Invasive Bladder Cancer

Interventions: Drug: AZD4547
Drug: MEDI4736
Drug: Vistusertib
Drug: AZD9150
Drug: Olaparib
Drug: AZD1775
Drug: Selumetinib

First Posted Date: 2015-09-11

Last Posted Date: 2025-04-13

Lead Sponsor: AstraZeneca

Target Recruit Count: 117

Registration Number: NCT02546661

Locations: 🇬🇧
Research Site, Southampton, United Kingdom

Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)

Phase 3

Active, not recruiting

Conditions: Non Small Cell Lung Carcinoma NSCLC

Interventions: Biological: Durvalumab +Tremelimumab
Drug: Paclitaxel + carboplatin
Drug: Gemcitabine + cisplatin
Drug: Gemcitabine + carboplatin
Drug: Pemetrexed + cisplatin
Drug: Pemetrexed + carboplatin

First Posted Date: 2015-09-07

Last Posted Date: 2025-01-16

Lead Sponsor: AstraZeneca

Target Recruit Count: 953

Registration Number: NCT02542293

Locations: 🇬🇧
Research Site, Wolverhampton, United Kingdom

Durvalumab With or Without Tremelimumab in Advanced Incurable Solid Malignancies Given With or Without Standard Chemotherapy Regimens

Phase 1

Active, not recruiting

Conditions: Solid Malignancies

Interventions: Drug: durvalumab
Drug: tremelimumab

First Posted Date: 2015-09-01

Last Posted Date: 2025-02-17

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 153

Registration Number: NCT02537418

Locations: 🇨🇦
Tom Baker Cancer Centre, Calgary, Alberta, Canada
🇨🇦
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
🇨🇦
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada

and more 4 locations

Adjuvant Durvalumab for Esophageal Cancer

Phase 2

Conditions: Esophageal Cancer

Interventions: Drug: Durvalumab
Drug: Placebo

First Posted Date: 2015-08-11

Last Posted Date: 2019-12-09

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 86

Registration Number: NCT02520453

Locations: 🇰🇷
Samsung Medical Center, Seoul, MA, Korea, Republic of

A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

Phase 2

Active, not recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Biological: Tremelimumab
Biological: Durvalumab
Biological: Bevacizumab

First Posted Date: 2015-08-10

Last Posted Date: 2025-02-20

Lead Sponsor: MedImmune LLC

Target Recruit Count: 433

Registration Number: NCT02519348

Locations: 🇨🇳
Research Site, Taoyuan City, Taiwan

MEDI9447 Alone and in Combination With MEDI4736 in Adult Participants With Select Advanced Solid Tumors.

Phase 1

Completed

Conditions: Solid Tumors

Interventions: Drug: Oleclumab
Drug: Durvalumab

First Posted Date: 2015-07-21

Last Posted Date: 2023-07-11

Lead Sponsor: MedImmune LLC

Target Recruit Count: 192

Registration Number: NCT02503774

Locations: 🇰🇷
Research Site, Seoul, Korea, Republic of

Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck

Phase 1

Active, not recruiting

Conditions: Advanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: AZD9150
Drug: MEDI4736
Drug: AZD5069
Drug: tremelimumab (treme)

First Posted Date: 2015-07-16

Last Posted Date: 2025-04-27

Lead Sponsor: AstraZeneca

Target Recruit Count: 340

Registration Number: NCT02499328

Locations: 🇬🇧
Research Site, Taunton, United Kingdom

A Pilot Study of Response-Driven Adaptive Radiation Therapy for Patients With Locally Advanced Non-Small Cell Lung Cancer

Not Applicable

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Radiation: Response-driven Adaptive Radiation Therapy
Drug: Carboplatin
Drug: Paclitaxel
Device: FDG-PET
Device: V/Q SPECT
Drug: Durvalumab

First Posted Date: 2015-07-09

Last Posted Date: 2023-08-31

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 49

Registration Number: NCT02492867

Locations: 🇺🇸
VA Ann Arbor Healthcare System, Ann Arbor, Michigan, United States
🇺🇸
University of Michigan Cancer Center, Ann Arbor, Michigan, United States

Neoadjuvant MEDI4736 Concomitant With Weekly Nab-paclitaxel and Dose-dense AC for Stage I-III Triple Negative Breast Cancer

Phase 1

Completed

Conditions: Breast Neoplasms

Interventions: Drug: MEDI4736

First Posted Date: 2015-07-03

Last Posted Date: 2022-10-26

Lead Sponsor: Yale University

Target Recruit Count: 68

Registration Number: NCT02489448

Locations: 🇺🇸
Yale School of Medicine, New Haven, Connecticut, United States

Drug Development Updates

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