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.
European biotechs are exploring new immunotherapy targets beyond PD-1/PD-L1, including BTLA, TIGIT, and SLAMF6. Lund University researchers discovered a SLAMF6-mediated immune evasion mechanism. BioNTech and GenMab are advancing next-generation ICIs and bispecific antibodies through strategic partnerships.
Durvalumab has been approved for rollout on the NHS for muscle-invasive bladder cancer. In a trial of more than 1,000 patients, it cut the risk of progression by 32% versus standard care.
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.
Dizal's Phase III trial of Zegfrovy for first-line NSCLC with EGFR exon20ins met its primary endpoint, showing improved progression-free survival. Meanwhile, Immutep halted its Phase III eftilagimod alfa trial, and AstraZeneca's LATIFY trial of ceralasertib plus Imfinzi failed to meet its overall survival endpoint.
AIM ImmunoTech partners with Thermo Fisher to design Phase 3 trial for Ampligen in pancreatic cancer, while Innovent Biologics begins dosing patients in Phase 3 study of IBI354 for HER2-positive breast cancer.
New ASCO guideline emphasizes biomarker-driven treatment for advanced gastroesophageal cancer, recommending upfront testing for HER2, PD-L1, MSI/MMR, and CLDN18.2 to guide immunotherapy and targeted therapy selection.
AIM ImmunoTech outlined key milestones for its Phase 2 DURIPANC trial evaluating Ampligen combined with durvalumab in metastatic pancreatic cancer, with primary endpoint evaluation expected in December 2026.
The FDA approved KEYTRUDA and its subcutaneous QLEX formulation for platinum-resistant ovarian cancer, marking the first PD-1 inhibitor cleared for this patient population based on Phase 3 results.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07554339 |
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07531095 |
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) |
RECRUITING | PHASE1 |
| NCT07511504 |
Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanced Hepatocellular Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07507968 |
TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07459634 |
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC |
NOT_YET_RECRUITING | PHASE2 |
| NCT07361497 |
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201) |
RECRUITING | PHASE3 |
| NCT07339059 |
Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer |
RECRUITING | PHASE2 |
| NCT07332351 |
Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial |
NOT_YET_RECRUITING | PHASE2 |
| NCT07288034 |
Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial |
RECRUITING | PHASE2 |
| NCT07247786 |
Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NSCLC Patients Using ICI Responders as Donors (MIGRANT) |
NOT_YET_RECRUITING | PHASE2 |
