Durvalumab

(Imfinzi®)

Durvalumab

Drug updated on 10/30/2024

Dosage FormInjection (intravenous; 500 mg/10 mL [50 mg/mL], 120 mg/2.4 mL [50 mg/mL])
Drug ClassProgrammed death-ligand 1 blocking antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements
  • Indicated as a single agent, for the treatment of adult patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy
  • Indicated in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations
  • Indicated in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
  • Indicated in combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC)
  • Indicated in combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC)
  • Indicated in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

Latest News

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Summary
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  • This summary is based on the review of 35 systematic review(s)/meta-analysis(es). [1-35]
  • Biliary Tract Cancer (BTC) Patients: The addition of immunotherapy to gemcitabine and cisplatin (GemCis) significantly improved overall survival (OS), with a mean OS difference of 1.21 months at 24 months (95% CI: 0.49-1.93, p < 0.001). In the TOPAZ-1 and KEYNOTE-966 trials, patients treated with GemCis plus durvalumab or pembrolizumab had OS of 13.52 and 13.60 months, respectively, compared to GemCis alone.
  • Hepatocellular Carcinoma (HCC) Patients: Tremelimumab plus durvalumab (Tre + Du) provided a comparable OS benefit to atezolizumab plus bevacizumab (Atezo + Beva). Progression-free survival (PFS) was higher with Atezo + Beva compared to Tre + Du.
  • Non-Small Cell Lung Cancer (NSCLC) Patients: Consolidation therapy with immune checkpoint inhibitors (ICIs) following chemoradiotherapy (CRT) significantly improved OS (1-year OS: 77% vs. 83%) and PFS (1-year PFS: 51% vs. 53%) compared to CRT alone. Durvalumab further improved 1-year OS to 85% and 1-year PFS to 60% in real-world studies. Durvalumab consolidation therapy following chemoradiotherapy was associated with an overall pneumonitis rate of 27-41%, with grade ≥3 pneumonitis occurring in 6-8% of patients. This safety profile was consistent with findings in the PACIFIC trial and real-world studies.
  • Triple-Negative Breast Cancer (TNBC) Patients: Pembrolizumab plus chemotherapy demonstrated superior OS and PFS outcomes compared to other treatments, particularly in PD-L1-positive populations. Pembrolizumab plus chemotherapy led to a higher incidence of grade ≥3 treatment-related adverse events (trAEs) compared to other regimens, with atezolizumab showing fewer grade ≥3 adverse events.
  • Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M-HNSCC) Patients: Combination therapy of durvalumab and tremelimumab resulted in higher rates of grade 3-4 trAEs and treatment discontinuation compared to durvalumab monotherapy, although overall adverse event rates were similar between the groups.
  • Population and Subgroup Considerations: Across the studies, certain subgroups exhibited higher efficacy with specific treatments. HCC patients from the Asia-Pacific region and those with HBV infection showed enhanced response rates to durvalumab-based therapies. In NSCLC patients, greater survival benefits were observed in those with PD-L1 expression ≥1%. TNBC patients who were PD-L1 positive demonstrated superior outcomes when treated with pembrolizumab plus chemotherapy. BTC patients consistently showed improved OS and PFS across various subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
Imfinzi (durvalumab) Prescribing Information.2024AstraZeneca, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The role of immune checkpoint inhibitors in the first-line treatment for patients with advanced biliary tract cancer: a systematic review and meta-analysis of randomized trials2024Frontiers in Oncology
Evaluation of Overall Survival by Restricted Mean Survival Time of Advanced Biliary Tract Cancer treated with Immunotherapy: A Systematic Review and Meta-Analysis2024Cancers
The emerging therapies are reshaping the first-line treatment for advanced hepatocellular carcinoma: a systematic review and network meta-analysis2024Therapeutic Advances in Gastroenterology
Efficacy of consolidation of immune checkpoint inhibitor after chemoradiation for unresectable, locally advanced PD‑L1 negative non‑small cell lung cancer: A systematic review and meta‑analysis2024Oncology Letters
Chemoradiotherapy Combined with Immunotherapy in Stage III Non-Small Cell Lung Cancer: A Systematic Review and Meta-Analysis of Efficacy and Safety Outcomes2024Oncology
Immune Checkpoint Inhibitors Serve as the First-Line Treatment for Advanced Head and Neck Cancer2024The Laryngoscope
Durvalumab with or without tremelimumab for patients with recurrent or metastatic squamous cell carcinoma of the head and neck: a systematic review and meta-analysis2023Frontiers in Immunology
Atezolizumab in Combination with Bevacizumab for the Management of Patients with Hepatocellular Carcinoma in the First-Line Setting: Systematic Literature Review and Meta-Analysis2023Liver Cancer
The timing of durvalumab administration affects the risk of pneumonitis in patients with locally advanced non-small cell lung cancer: a systematic review and meta-analysis2023BMC Cancer
Adverse events induced by durvalumab and tremelimumab combination regimens: a systematic review and meta-analysis2023Therapeutic Advances in Medical Oncology
Efficacy and safety of consolidation durvalumab after chemoradiation therapy for stage III non-small-cell lung cancer: a systematic review, meta-analysis, and meta-regression of real-world studies2023Frontiers in Pharmacology
Immune checkpoint inhibitors in first-line therapies of metastatic or early triple-negative breast cancer: a systematic review and network meta-analysis2023Frontiers in Endocrinology
Comparative efficacy and safety of PD-1/PD-L1 inhibitors in triple negative breast cancer: a systematic review and network meta-analysis of randomized controlled trials2023Cancer Cell International
Comprehensive Evaluation of Anti-PD-1, Anti-PD-L1, Anti-CTLA-4 and Their Combined Immunotherapy in Clinical Trials: A Systematic Review and Meta-analysis2022Frontiers in Pharmacology
How Immunotherapy Modified the Therapeutic Scenario of Endometrial Cancer: A Systematic Review2022Frontiers in Oncology
From Interferon to Checkpoint Inhibition Therapy-A Systematic Review of New Immune-Modulating Agents in Bacillus Calmette-Guerin (BCG) Refractory Non-Muscle-Invasive Bladder Cancer (NMIBC)2022Cancers
Severe immune-related adverse events of immune checkpoint inhibitors for advanced non-small cell lung cancer: a network meta-analysis of randomized clinical trials2022Cancer Immunology
Addition of Immune Checkpoint Inhibitors to Chemotherapy vs Chemotherapy Alone as First-Line Treatment in Extensive-Stage Small-Cell Lung Carcinoma: A Systematic Review and Meta-Analysis2022Oncology and Therapy
Real-World Safety and Efficacy of Consolidation Durvalumab After Chemoradiation Therapy for Stage III Non-small Cell Lung Cancer: A Systematic Review and Meta-analysis2022International Journal of Radiation Oncology
The relationship between blood-based tumor mutation burden level and efficacy of PD-1/PD-L1 inhibitors in advanced non-small cell lung cancer: a systematic review and meta-analysis2021BMC Cancer
Adverse events associated with immune checkpoint inhibitors in patients with breast cancer: A systematic review and meta-analysis2021International Immunopharmacology
Meta-analysis of immune-related adverse events in phase 3 clinical trials assessing immune checkpoint inhibitors for lung cancer2021Critical Reviews in Oncology/Hematology
Immune checkpoint inhibitors for treatment of small-cell lung cancer: a systematic review and meta-analysis2021Annals of Translational Medicine
Immune Checkpoint Inhibition With Chemoradiotherapy in Stage III Non-small-cell Lung Cancer: A Systematic Review and Meta-analysis of Safety Results2021Clinical Lung Cancer
Systematic review of first-line chemotherapy for chemo-naive extensive-stage small-cell lung cancer: network meta-analysis2020Therapeutic Advances in Medical Oncology
The efficiency and safety of immune checkpoint inhibitors in the treatment of small cell lung cancer: a meta-analysis2020Annals of Palliative Medicine
Diagnosis and Management of Hematological Adverse Events Induced by Immune Checkpoint Inhibitors: A Systematic Review2020Frontiers in Immunology
Rationale and Outcomes for Neoadjuvant Immunotherapy in Urothelial Carcinoma of the Bladder2020European Urology Oncology
Efficacy and safety of immune checkpoint inhibitors in patients with advanced non-small cell lung cancer (NSCLC): a systematic literature review2020Oncoimmunology
Durvalumab and tremelimumab combination therapy versus durvalumab or tremelimumab monotherapy for patients with solid tumors: A systematic review and meta-analysis2020Medicine
Meta-analysis of immune-related adverse events of immune checkpoint inhibitor therapy in cancer patients2020Thoracic Cancer
The efficacy and safety of immunotherapy targeting the PD-1 pathway for advanced urothelial carcinoma: a meta-analysis of published clinical trials2020Clinical & Translational Oncology
Programmed cell death-1 inhibitor-related sclerosing cholangitis: A systematic review2020World Journal of Gastroenterology
Association of PD-L1 expression status with the efficacy of PD-1/PD-L1 inhibitors and overall survival in solid tumours: A systematic review and meta-analysis2020International Journal of Cancer
The Differences in the Safety and Tolerability of Immune Checkpoint Inhibitors as Treatment for Non-Small Cell Lung Cancer and Melanoma: Network Meta-Analysis and Systematic Review2019Frontiers in Pharmacology

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