Durvalumab

Drug

Drug Profile

Durvalumab is a human IgG1 monoclonal antibody immune checkpoint inhibitor marketed as Imfinzi and used across multiple cancers including lung, biliary tract, bladder, endometrial, and gastric/GEJ settings. It targets PD-L1 and blocks PD-L1 interactions with PD-1 and CD80 on T cells. The product has U.S. approvals since 2017 with continued indication expansions.

Drug Class
Immune checkpoint inhibitor monoclonal antibody (anti-PD-L1)
Approval Status
Approved for medical use in the United States in May 2017 and in the European Union in September 2018, with multiple later FDA label expansions through 2025
Mechanism of Action
Binds PD-L1 and blocks PD-L1 interactions with PD-1 and CD80 on T cells
Brand Names
  • Imfinzi
Indications
  • \Urothelial carcinoma\
  • \Stage III unresectable NSCLC after chemoradiation\
  • \Extensive-stage small cell lung cancer (with platinum-etoposide)\
  • \Biliary tract cancer (with gemcitabine/cisplatin)\
  • \Additional approved uses including endometrial, muscle-invasive bladder, and gastric/GEJ adenocarcinoma regimens\

Related News

Hengrui Gets NMPA Nod for ADC Phase II Trial, Reports Positive Obesity Data

Hengrui Medicine won NMPA clearance for a Phase II NSCLC trial combining SHR-A2009 ADC with adebrelimab or EGFR-TKI, and with partner Kailera reported up to 12.1% weight loss in a Phase II obesity study of oral ribupatide. SHR-A2009 monotherapy NDA is under review for NSCLC, and cumulative R&D on SHR-A2009 has reached RMB 330 million.

Recent Cancer Research Advances Span Treatments and Biomarkers

A phase one trial of RSO-021 achieved disease control in 67% of relapsed mesothelioma patients. Other advances include daraxonrasib for NRAS-driven melanoma, an aneuploidy biomarker for PARP inhibitor response in childhood cancers, and new research into a cancer target and cholangiocarcinoma treatment.

Studies Evaluate Thoracic Radiotherapy Approaches in Lung Cancer

Two studies report on thoracic radiotherapy for lung cancer: a phase III trial found adding radiotherapy to chemoimmunotherapy did not improve survival in extensive-stage small cell lung cancer, while a retrospective review showed high local control rates with single-fraction 28 Gy stereotactic body radiotherapy.

Clinical Trial Advances in Cancer Immunotherapy and Targeted Therapies

Moderna and Merck advance a Phase 2 trial of mRNA cancer vaccine V940 with pembrolizumab and chemotherapy for metastatic squamous NSCLC. In biliary tract cancer, first-line treatment combines chemotherapy with immunotherapy, while targeted therapy resistance prompts liquid biopsy. ImmunityBio tests a chemotherapy-free NK-cell regimen in non-Hodgkin lymphoma.

Related Clinical Trials

NCT ID Title Status Phase
NCT07766187

Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma

NOT_YET_RECRUITING PHASE2
NCT07765433

Testing the Addition of Ivonescimab Combined With Standard Chemotherapy Compared to the Usual Chemotherapy and Immunotherapy Treatment for Patients With Advanced Biliary Tract Cancer

NOT_YET_RECRUITING PHASE2/PHASE3
NCT07759492

Personnalized Immunotherapy in Patients With Stage III Non-small Cell Lung Cancer

NOT_YET_RECRUITING PHASE2
NCT07720284

An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC

RECRUITING PHASE3
NCT07718139

Demographics, Clinical Characteristics and Outcomes in Resected Non-Small Cell Lung Cancer Patients Receiving Immunotherapy in Europe and Canada

ACTIVE_NOT_RECRUITING
NCT07710885

Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer

RECRUITING PHASE3
NCT07672223

A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)

NOT_YET_RECRUITING PHASE3
NCT07639528

Preoperative Durvalumab, Cisplatin, Gemcitabine With or Without Futibatinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, OPTIC Trial

NOT_YET_RECRUITING PHASE2
NCT07637513

Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer

NOT_YET_RECRUITING PHASE3
NCT07625930

RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial

NOT_YET_RECRUITING PHASE2