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DRUG:

Imfinzi (durvalumab)

i
Other names: MEDI4736, MEDI-4736, MEDI 4736
Company:
AstraZeneca
Drug class:
PD-L1 inhibitor
Related drugs:
17h
Current Development of Perioperative Immune Checkpoint Inhibitor Therapy for Muscle-Invasive Bladder Cancer (PubMed, Gan To Kagaku Ryoho)
Muscle-invasive bladder cancer(MIBC)carries a high risk of recurrence.The standard treatment has been cisplatin-based neoadjuvant chemotherapy(NAC)followed by radical cystectomy(RC), but nearly half of patients are cisplatin-ineligible and unable to receive optimal NAC.Furthermore, recurrence after NAC plus RC remains common, highlighting the need for effective adjuvant strategies.Recent advances in immune checkpoint inhibitors(ICIs)have revolutionized perioperative treatment paradigms.The phase Ⅲ CheckMate 274 trial demonstrated that adjuvant nivolumab significantly prolonged disease-free survival(DFS), particularly in PD-L1-positive patients.In the IMvigor010 trial, adjuvant atezolizumab did not improve DFS in the overall population, but a biomarker-driven subanalysis revealed marked benefit in patients with postoperative circulating tumor DNA(ctDNA)positivity.Based on these findings, the ongoing IMvigor011 trial restricts adjuvant atezolizumab to ctDNA-positive patients.The NIAGARA trial evaluated a comprehensive perioperative approach using neoadjuvant gemcitabine-cisplatin plus durvalumab followed by adjuvant durvalumab for 1 year.This regimen significantly improved DFS, overall survival(OS), and pathological complete response(pCR)rates without increasing Grade ≥3 toxicities.ctDNA has emerged as a promising biomarker for risk stratification and treatment monitoring, potentially enabling precision perioperative immunotherapy.This review summarizes pivotal phase Ⅲ trials of perioperative ICI therapy in MIBC and discusses the role of ctDNA-guided strategies, envisioning a shift from universal ICI administration to biomarker-driven, individualized perioperative approaches.
Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • gemcitabine
3d
Trial of INI-4001 in Patients With Advanced Solid Tumours (clinicaltrials.gov)
P1, N=50, Recruiting, Inimmune Corporation | Not yet recruiting --> Recruiting | Trial completion date: Apr 2026 --> Mar 2027 | Trial primary completion date: Aug 2024 --> Oct 2026
Enrollment open • Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Libtayo (cemiplimab-rwlc)
3d
A Case of Simultaneous Resection of Single Lung and Liver Metastases with Combined Immunotherapy after Radical Surgery for Hepatocellular Carcinoma (PubMed, Gan To Kagaku Ryoho)
Early postoperatively, he developed a single S3 metastasis in the left lung and started combination therapy with atezolizumab plus bevacizumab...He was treated with lenvatinib for a short period of time postoperatively, but recurred multiple metastases in both lungs on CT scan 3 months later. He has been treated with a combination of durvalumab plus tremelimumab while submitting to cancer genome testing, which revealed TMB-high and MSI-high. Tissue sampling is essential for the diagnosis of inter-hepatic metastasis or multicentric occurrence, and in the case of ipsilateral hepatopulmonary metastasis, trans-diaphragmatic approach surgery is effective for less incision surgery. Combined immunoadjuvant therapy for resected HCC has shown efficacy in short-term results.
Journal
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TMB (Tumor Mutational Burden)
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TMB-H • MSI-H/dMMR
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Lenvima (lenvatinib) • Imjudo (tremelimumab-actl)
4d
Emerging Therapeutic Synergies: Combining PD-1 Inhibitors With Poly-ADP-Ribose Polymerase (PARP) Inhibitors in the Treatment of Gynecologic Cancers. (PubMed, Cureus)
In recurrent ovarian cancer, niraparib+pembrolizumab showed modest activity with durable responses in homologous recombination-deficient (HRD) tumors; olaparib+durvalumab demonstrated high activity in gBRCA platinum-sensitive relapse, and adding bevacizumab broadened benefit in non-BRCA cohorts. In the newly diagnosed disease, rucaparib+nivolumab maintenance failed to improve PFS versus rucaparib alone. Endometrial trials (olaparib+durvalumab; talazoparib+avelumab in mismatch repair-proficient disease) showed limited activity overall, with signals restricted to biomarker-selected subgroups...PARP+PD-1/PD-L1 combinations are most compelling in ovarian cancer, particularly in BRCA/HRD tumors and, in selected settings, with the addition of bevacizumab, while frontline maintenance benefit remains unproven and endometrial activity is modest. Biomarker-guided selection, rational triplets with non-cytotoxic partners, and optimized sequencing warrant further evaluation.
Review • Journal • BRCA Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
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HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • STING (stimulator of interferon response cGAMP interactor 1)
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • Bavencio (avelumab) • Talzenna (talazoparib) • Zejula (niraparib) • Rubraca (rucaparib)
4d
Enrollment open
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IL2 (Interleukin 2)
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Opdivo (nivolumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl) • Aybintio (bevacizumab biosimilar) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn)
5d
Tumor Mutational Burden-High Intrahepatic Cholangiocarcinoma Presenting with Solitary Brain Metastasis: A Case of Precision Oncology. (PubMed, Surg Case Rep)
This case suggests that an integrated approach, combining aggressive local therapy with systemic immunotherapy informed by biomarkers, can achieve a favorable outcome in selected patients with ICC. The identification of a high tumor mutational burden was crucial in guiding treatment and supports its potential as a predictive biomarker. This precision oncology strategy may improve the poor prognosis associated with this condition.
Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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TMB (Tumor Mutational Burden)
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TMB-H
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cisplatin • Imfinzi (durvalumab) • gemcitabine
5d
Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI (clinicaltrials.gov)
P=N/A, N=236, Completed, AstraZeneca | Active, not recruiting --> Completed | Trial completion date: Jul 2026 --> Nov 2025 | Trial primary completion date: Jul 2026 --> Nov 2025
Trial completion • Trial completion date • Trial primary completion date
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Imfinzi (durvalumab)
6d
ENHANCE: A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
P2, N=60, Recruiting, John Sfakianos | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1)
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Imfinzi (durvalumab) • monalizumab (IPH2201)
7d
Durvalumab-containing treatment for recurrent or metastatic pulmonary sarcomatoid carcinoma: A pooled post hoc analysis of two KCSG phase II trials. (PubMed, Lung Cancer)
Durvalumab-containing combination therapy showed promising efficacy in patients with R/M PSC, irrespective of PD-L1 expression. A lower CD4+/CD8+ ratio may be associated with favorable disease control.
P2 data • Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
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Imfinzi (durvalumab)
7d
Adjuvant Durvalumab in Completely Resected Early-Stage Non-Small Cell Lung Cancer. (PubMed, J Clin Oncol)
Adjuvant durvalumab following complete resection was not associated with improvement in DFS compared with placebo in EGFR-/ALK- NSCLC, regardless of PD-L1 status.
Journal • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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PD-L1 expression • EGFR mutation • ALK rearrangement
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Imfinzi (durvalumab)
7d
Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx
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Keytruda (pembrolizumab) • carboplatin • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • Datroway (datopotamab deruxtecan-dlnk)
8d
New P2 trial
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cisplatin • Imfinzi (durvalumab) • gemcitabine • Adstiladrin (nadofaragene firadenovec-vncg)