Drug updated on 4/29/2024
| 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 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 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 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).
Summary
- Durvalumab (Imfinzi) is indicated for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (ES-SCLC), metastatic NSCLC without sensitizing EGFR mutations or ALK genomic tumor aberrations, locally advanced or metastatic biliary tract cancer (BTC), and unresectable hepatocellular carcinoma.
- A total of 13 systematic reviews/meta-analyses were reviewed to gather information about Durvalumab's safety and effectiveness in treating these conditions.
- In terms of effectiveness, when combined with chemotherapy, Durvalumab showed a favorable effect on overall survival and progression-free survival for patients with ES-SCLC compared to chemotherapy alone; it also improved outcomes in stage III NSCLC when added to chemoradiation therapy.
- The addition of Durvalumab into treatment regimens did not significantly increase the risk of experiencing any adverse events compared to chemotherapy alone suggesting a relatively favorable safety profile; however, it has been associated with higher incidences of immune-related adverse events requiring vigilant monitoring.
- For ES-SCLC treatment efficacy favored all planned subgroups according to age, sex and ECOG performance status indicating broad applicability across different patient demographics but particular attention is warranted for elderly poor-performance status patients receiving post-chemoradiation treatments in stage III NSCLS due demographic factors influencing certain side effects like pneumonitis rates.
- Compared against other immune checkpoint inhibitors such as atezolizumab while treating extensive-stage small cell lung cancer using platinum-etoposide plus immunotherapy had higher incidences grade 3 adverse events necessitating careful management side effects despite superior objective response rates from durvalumb-based regimen.
- Duravalumb demonstrated comparable or superior efficacy particularly when combined CT reflecting its strong potential specific contexts within ES-SCLC treatment landscape.
- Across various populations including different ages and ECOG statuses, Durvalumab maintains a consistent safety profile though attention to specific adverse events and subgroups is advised to maximize patient outcomes.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Imfinzi (durvalumab) Prescribing Information. | 2022 | 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 |