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durvalumab (Imfinzi)

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: - pneumonitis 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 Mechanism of action: - human IgG1 monoclonal antibody - PD-L1 inhibitor - blocks PD-L1 binding to PD-1 & CD80

Interactions

drug adverse effects of checkpoint inhibitor(s)

General

antineoplastic monoclonal antibody checkpoint inhibitor; immune checkpoint inhibitor; PD-1/PD-L1 inhibitor

References

  1. 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 PMID: 28885881 Free full text http://www.nejm.org/doi/full/10.1056/NEJMoa1709937
  2. 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
  3. 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: 28817753
  4. Mulcahy N FDA OKs Durvalumab (Imfinzi) for Reducing Risk for NSCLC Progression, Medscape - Feb 16, 2018. https://www.medscape.com/viewarticle/892819
  5. 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. 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
  7. Medscape: durvalumab (Rx) https://reference.medscape.com/drug/imfinzi-durvalumab-1000145 - Imfinzi prescribing information https://www.azpicentral.com/imfinzi/imfinzi.pdf