durvalumab (Imfinzi)
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Indications
- advanced of metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy
- improves progression-free survival after completion of chemoradiation for non-small cell lung carcinoma[1]
- median time to death or distant metastasis longer with durvalumab than with placebo (23.2 months vs 14.6 months)[1]
- FDA-approved for NSCLC after chemoradiation[4]
- metastatic head & neck cancer PD-L1 negative[5]
- hepatocellular carcinoma[6]
Contraindications
Dosage
- 10 mg/kg IV infusion over 60 minutes every 2 weeks
- continue until disease progression or unacceptable toxicity[2]
- durvalumab plus tremelimumab
- 20 mg/kg durvalumab every 4 weeks + tremelimumab 1 mg/kg every 4 weeks for 4 cycles, then durvalumab 10 mg/kg every 2 weeks[5]
single dose vials: 50 mg/mL, 500 mg/10 mL, 120 mg/2.4 mL
Adverse effects
- >= 15%
- fatigue
- musculoskeletal pain,
- constipation
- decreased appetite
- nausea
- peripheral edema
- urinary tract infection
- drug adverse effects of checkpoint inhibitor(s)
- drug adverse effects of pharmaceutical monoclonal antibodies
Mechanism of action
More general terms
References
- ↑ 1.0 1.1 1.2 Kris G Durvalumab After Chemoradiotherapy 'Immediately Changes Practice' in Patients With NSCLC. Medscape - Oct 27, 2017. https://www.medscape.com/viewarticle/887419
Antonia SJ, Villegas A, Daniel D et al Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med 2017; 377:1919-1929. November 16, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28885881 Free full text <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1709937 - ↑ 2.0 2.1 Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871
U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm - ↑ Powles T, O'Donnell PH, Massard C et al Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study. JAMA Oncol. 2017 Sep 14;3(9):e172411. Epub 2017 Sep 14. PMID: https://www.ncbi.nlm.nih.gov/pubmed/28817753
- ↑ 4.0 4.1 Mulcahy N FDA OKs Durvalumab (Imfinzi) for Reducing Risk for NSCLC Progression, Medscape - Feb 16, 2018. https://www.medscape.com/viewarticle/892819
- ↑ 5.0 5.1 5.2 Fuerst ML with comments by Klil-Drori AJ Durvalumab Combo Slows PD-L1-neg Advanced Head and Neck Cancer. Increase in 'clinically relevant' overall survival, with manageable toxicity MedPage Today. ASCO Reading Room 05.03.2018 https://www.medpagetoday.com/reading-room/asco/immunotherapy/72666
Siu L, et al A randomized, open-label, multicenter, global phase 2 study of durvalumab (D), tremelimumab (T), or D plus T in patients with PD-L1 low/negative recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): CONDOR Int J Rad Oncol Biol Physics 2018; 100 (5): 1307. Not indexed in PubMed - ↑ 6.0 6.1 Leiser M FDA approves tremelimumab with durvalumab for advanced liver cancer. Helio. Oct 24, 2022 https://www.healio.com/news/hematology-oncology/20221024/fda-approves-tremelimumab-with-durvalumab-for-advanced-liver-cancer
- ↑ Imfinzi prescribing information https://www.azpicentral.com/imfinzi/imfinzi.pdf