• The use of Tecentriq in patients on dialysis have not been formally established.
• The use of Tecentriq is not contraindicated in patients requiring dialysis.
• Atezolizumab has a large molecular weight (144.356 kDa) and should continue to circulate in serum after dialysis.
• Patients on dialysis were excluded from Roche pivotal clinical trials.
• Case reports of dialysis patients using Tecentriq are available.

AE= Adverse event

eGFR= Estimated glomerular filtration rate

ES-SCLC= Extensive-stage small cell lung cancer 

GU= Genitourinary 

HD= Hemodialysis

IV= Intravenous

kDA= Kilodaltons

LCNEC= Large cell neuroendocrine carcinoma

NSCLC= Non-small cell lung cancer

PK= Pharmacokinetics

UC= Urothelial cell carcinoma

The use of Tecentriq in patients requiring dialysis is not contraindicated, however the safety and efficacy has not been formally assessed. Administering Tecentriq to patients on dialysis would be a decision made by the treating physician, and should be based upon an appropriate risk-benefit assessment.

Tecentriq-related AEs with relevance to renal function were observed in Tecentriq clinical trials: [1]

• Blood creatinine increased (common, ≥ 1/100 to < 1/10)
• Nephritis (uncommon, ≥ 1/1000 to < 1/100)

Appropriate clinical caution and monitoring is recommended. Patients should be monitored for changes in renal function. Tecentriq should be used as described in the local label.

The pharmacokinetics of Tecentriq in patients on dialysis has not been formally established. 

Roche’s Phase 1 study assessing Tecentriq pharmacokinetics in patients with renal dysfunction did not include patients on dialysis.[1] Only 8 patients with severe renal impairment (eGFR 15 to 29 ml/min/1.73 m²) were included, thus data on patients with severe renal impairment is too limited to formal conclusions in this patient population.

There were no clinically meaningful differences in the clearance of Tecentriq in patients with mild (eGFR 60 to 89 ml/min/1.73 m²; n = 208) or moderate (eGFR 30 to 59 ml/min/1.73 m²; n = 116) renal impairment compared with patients with normal renal function (eGFR greater than or equal to 90 ml/min/1.73 m²; n = 140).

According to these results, no Tecentriq dose adjustments were recommended in patients with mild to moderate renal impairment.[1 See local label for further information on the PK of Tecentriq.

Dialysis membranes are typically permeable to molecules up to 15 kDa. Larger molecules are retained by dialysis membranes. 

As atezolizumab has a molecular weight of 144.356 kDa, [2] it should not be filtered out of the body during dialysis [3]. Tecentriq should therefore continue to circulate in serum after dialysis.

Patients on dialysis were excluded from Tecentriq pivotal clinical trials, including OAK [4], IMvigor210 [5], and IMpower150 [6], however patients with mild to moderate renal impairment were included.

The SAUL study was a single-arm, multicenter, international, open-label Phase 3b study that evaluated the safety and efficacy of Tecentriq 1,200 mg IV every three weeks in patients with previously treated, locally advanced or metastatic UC or non-urothelial carcinoma of the urinary tract.[7] The SAUL study included patients who were generally ineligible for clinical trials, such as those with renal impairment or requiring dialysis. 46 patients (5%) of patients in SAUL had severe renal dysfunction (creatinine clearance of <30 ml/min), however no patients requiring dialysis were enrolled.[8]

Table 1 provides information on published case reports of dialysis patients receiving Tecentriq.

Table 1: Case reports of patients receiving Tecentriq whilst on dialysis

1. Roche Internal Regulatory Document (Accessed July 2023).
2. FDA Pharmacology/ toxicology BLA review and evaluation of Tecentriq (UC). Available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761034Orig1s000PharmR.pdf.
3. Kitchlu A, Jhaveri K, Sprangers B, et al. Immune checkpoint inhibitor use in patients with end-stage kidney disease: an analysis of reported cases and literature review. Clin Kidney J 2021;14:2012-2022. https://www.ncbi.nlm.nih.gov/pubmed/34476087
4. Rittmeyer A, Barlesi F, Waterkamp D, et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet 2017;389:255-265. https://www.ncbi.nlm.nih.gov/pubmed/27979383
5. Balar A, Galsky M, Rosenberg J, et al. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet 2017;389:67-76. https://www.ncbi.nlm.nih.gov/pubmed/27939400
6. Socinski M, Jotte R, Cappuzzo F, et al. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med 2018;378:2288-2301. https://www.ncbi.nlm.nih.gov/pubmed/29863955
7. Sternberg CLYJNea. Primary Results from SAUL, a Multinational Single-arm Safety Study of Atezolizumab Therapy for Locally Advanced or Metastatic Urothelial or Nonurothelial Carcinoma of the Urinary Tract. Eur Urol 2019;76:73-81. https://www.ncbi.nlm.nih.gov/pubmed/30910346
8. Merseburger A, Castellano D, Powles T, et al. Safety and Efficacy of Atezolizumab in Understudied Populations with Pretreated Urinary Tract Carcinoma: Subgroup Analyses of the SAUL Study in Real-World Practice. J Urol 2021;206:240-251. https://www.ncbi.nlm.nih.gov/pubmed/33835866
9. Parisi A, Cortellini A, Cannita K, et al. Safe Administration of anti-PD-L1 Atezolizumab in a Patient with Metastatic Urothelial Cell Carcinoma and End-Stage Renal Disease on Dialysis. Case Rep Oncol Med 2019;2019:3452762. https://www.ncbi.nlm.nih.gov/pubmed/30881713
10. Cheun H, Kim M, Lee H, et al. Safety and efficacy of immune checkpoint inhibitors for end-stage renal disease patients undergoing dialysis: a retrospective case series and literature review. Invest New Drugs 2019;37:579-583. https://www.ncbi.nlm.nih.gov/pubmed/30298302
11. Hirsch J, Wanchoo R, Ng J, et al. Use of Immune Checkpoint Inhibitors in End Stage Kidney Disease Patients, Single Center Experience and Review of the Literature. Kidney360 2020;1:399-402. https://www.ncbi.nlm.nih.gov/pubmed/35369378
12. Mahmood A, Chowdhury S. Experience with atezolizumab immunotherapy for a patient with non-small cell lung cancer on renal dialysis. Lung Cancer 2019;127: S95-S96.
13. Imaji M, Fujimoto D, Kato M, et al. Chemotherapy plus atezolizumab for a patient with small cell lung cancer undergoing haemodialysis: a case report and review of literature. Respirol Case Rep 2021;9:e00741. https://www.ncbi.nlm.nih.gov/pubmed/33777399
14. Strohbehn I, Lee M, Seethapathy H, et al. Safety and Efficacy of Immune Checkpoint Inhibitors in Patients on Dialysis: A Retrospective Case Series. Am J Kidney Dis 2020;76:299-302. https://www.ncbi.nlm.nih.gov/pubmed/32417401
15. Watari N, Yamaguchi K, Masuda T, et al. Tolerability and efficacy of IMpower133 regimen modified for dialysis patients with extensive-stage small cell lung cancer: Two case reports. Thorac Cancer 2021;12:2956-2960. https://www.ncbi.nlm.nih.gov/pubmed/34587368
16. Cuenca A, Rosales I, Lee R, et al. Resolution of a High Grade and Metastatic BK Polyomavirus-Associated Urothelial Cell Carcinoma Following Radical Allograft Nephroureterectomy and Immune Checkpoint Treatment: A Case Report. Transplant Proc 2020;52:2720-2725. https://www.ncbi.nlm.nih.gov/pubmed/32741665
17. Kuo M, Su P, Huang C, et al. Safety and Efficacy of Immune Checkpoint Inhibitors for Patients With Metastatic Urothelial Carcinoma and End-Stage Renal Disease: Experiences From Real-World Practice. Front Oncol 2020;10:584834. https://www.ncbi.nlm.nih.gov/pubmed/33330066
18. Imai R, Kitamura A. Successful treatment with atezolizumab in a haemodialysis patient with large cell neuroendocrine carcinoma. Respirol Case Rep 2023;11:e01193. https://www.ncbi.nlm.nih.gov/pubmed/37484711