Drug updated on 10/30/2024
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 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
Summary
- 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 Title | Year | Source |
---|---|---|
Imfinzi (durvalumab) Prescribing Information. | 2024 | AstraZeneca, 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 |