Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 500 mg/10 mL [50 mg/mL], 120 mg/2.4 mL [50 mg/mL]) |
Drug Class | Programmed death-ligand 1 blocking antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (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 non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (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
Summary
- Imfinzi (durvalumab) is used to treat various types of lung cancer, including unresectable Stage III NSCLC and extensive-stage small cell lung cancer (ES-SCLC), often in combination with other therapies. It is also indicated for treating advanced or metastatic biliary tract cancer and unresectable hepatocellular carcinoma (uHCC). Additionally, Imfinzi is used in combination therapies for treating primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
- This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-20]
- NSCLC: Durvalumab demonstrated pooled 1-year OS and PFS rates of 85% and 60%, respectively, indicating effectiveness in unresectable stage III NSCLC. Real-world evidence supports these findings, showing consistency with the PACIFIC trial.
- ES-SCLC: Durvalumab combined with chemotherapy improved OS (HR 0.84) and PFS (HR 0.81) compared to chemotherapy alone. Durvalumab also showed superior ORR compared to atezolizumab. 5. aHCC: Durvalumab, particularly when combined with tremelimumab, showed PFS benefits over lenvatinib, donatinib, and tremelimumab alone. Among compared therapies, durvalumab was the most tolerated.
- BTC: The combination of GemCis + durvalumab indicated a trend toward improved OS and a significant PFS benefit over standard treatment (GemCis).
- Non-Small Cell Lung Cancer (NSCLC): The pooled incidence of all-grade pneumonitis was 27%, grade ≥3 pneumonitis was 8%, and discontinuation due to pneumonitis was 17%. The safety profile was consistent with the PACIFIC trial.
- Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Durvalumab was associated with a higher risk of any-grade and grade ≥3 adverse events compared to chemotherapy alone, with a higher incidence of immune-related adverse events compared to atezolizumab.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Imfinzi (durvalumab) Prescribing Information. | 2023 | AstraZeneca Pharmaceuticals LP., Wilmington, DE |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
A practical guide for the systemic treatment of biliary tract cancer in Canada. | 2023 | Current Oncology |
Society for immunotherapy of cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lung cancer and mesothelioma. | 2022 | Journal for Immunotherapy of Cancer |
Pan-Asian adapted ESMO Clinical Practice Guidelines for the management of patients with locally-advanced unresectable non-small-cell lung cancer: a KSMO-ESMO initiative endorsed by CSCO, ISMPO, JSMO, MOS, SSO and TOS. | 2020 | Annals of Oncology |
Management of immunotherapy-related toxicities, version 1.2019, NCCN Clinical Practice Guidelines in Oncology. | 2019 | Journal of the National Comprehensive Cancer Network |