Burotto M, Zvirbule Z, Mochalova A, Runglodvatana Y, Herraez-Baranda L, Liu SN, et al. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023;34(8):693–702.

Article  CAS  PubMed  Google Scholar 

Tecentriq. SUMMARY OF PRODUCT CHARACTERISTIC - Tecentriq. 2023.

Pharma F. Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes 2023 [Available from: https://www.fiercepharma.com/pharma/roches-subcutaneous-tecentriq-hits-fda-delay-amid-manufacturing-process-changes].

Roche. Roche’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types 2023 [Available from: https://www.roche.com/media/releases/med-cor-2023-11-14].

Felip E, Burotto M, Zvirbule Z, Herraez-Baranda LA, Chanu P, Kshirsagar S, et al. Results of a dose-finding phase 1b study of subcutaneous atezolizumab in patients with locally advanced or metastatic non-small cell lung cancer. Clin Pharmacol Drug Dev. 2021;10(10):1142–55.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bittner B, Richter W, Schmidt J. Subcutaneous administration of biotherapeutics: an overview of current challenges and opportunities. BioDrugs. 2018;32(5):425–40.

Article  PubMed  PubMed Central  Google Scholar 

Turner MR, Balu-Iyer SV. Challenges and opportunities for the subcutaneous delivery of therapeutic proteins. J Pharm Sci. 2018;107(5):1247–60.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Das M, Ogale S, Jovanoski N, Johnson A, Nguyen C, Bhagwakar J, Lee JS. Cost-effectiveness of adjuvant atezolizumab for patients with stage II-IIIA PD-L1+ non-small-cell lung cancer. Immunotherapy. 2023;15(8):573–81.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bluethmann SM, Mariotto AB, Rowland JH. Anticipating the “Silver Tsunami”: prevalence trajectories and comorbidity burden among older cancer survivors in the United States. Cancer Epidemiol Biomarkers Prev. 2016;25(7):1029–36.

Article  PubMed  PubMed Central  Google Scholar 

Leighl NB, Nirmalakumar S, Ezeife DA, Gyawali B. An arm and a leg: the rising cost of cancer drugs and impact on access. Am Soc Clin Oncol Educ Book. 2021;41:1–12.

Article  PubMed  Google Scholar 

Mariotto AB, Enewold L, Zhao J, Zeruto CA, Yabroff KR. Medical care costs associated with cancer survivorship in the United States. Cancer Epidemiol Biomarkers Prev. 2020;29(7):1304–12.

Article  PubMed  PubMed Central  Google Scholar 

Desai A, Gyawali B. Financial toxicity of cancer treatment: Moving the discussion from acknowledgement of the problem to identifying solutions. EClinicalMedicine. 2020;20: 100269.

Article  PubMed  PubMed Central  Google Scholar 

Pisu M, Martin MY. Financial toxicity: a common problem affecting patient care and health. Nat Rev Dis Primers. 2022;8(1):7.

Article  PubMed  PubMed Central  Google Scholar 

FDA. Pharmacokinetic-Based criteria for supporting alternative dosing regimens of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for treatment of patients with cancer guidance for industry. 2022. [Available from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetic-based-criteria-supporting-alternative-dosing-regimens-programmed-cell-death-receptor].

Hendrikx J, Haanen J, Voest EE, Schellens JHM, Huitema ADR, Beijnen JH. Fixed dosing of monoclonal antibodies in oncology. Oncologist. 2017;22(10):1212–21.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Zhao X, Suryawanshi S, Hruska M, Feng Y, Wang X, Shen J, et al. Assessment of nivolumab benefit-risk profile of a 240-mg flat dose relative to a 3-mg/kg dosing regimen in patients with advanced tumors. Ann Oncol. 2017;28(8):2002–8.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Freshwater T, Kondic A, Ahamadi M, Li CH, de Greef R, de Alwis D, Stone JA. Evaluation of dosing strategy for pembrolizumab for oncology indications. J Immunother Cancer. 2017;5:43.

Article  PubMed  PubMed Central  Google Scholar 

Deng R, Bumbaca D, Pastuskovas CV, Boswell CA, West D, Cowan KJ, et al. Preclinical pharmacokinetics, pharmacodynamics, tissue distribution, and tumor penetration of anti-PD-L1 monoclonal antibody, an immune checkpoint inhibitor. MAbs. 2016;8(3):593–603.

Article  CAS  PubMed  PubMed Central  Google Scholar 

FDA. Center for drug evaluation and research. Application number: 761034orig1s000. Clinical pharmacology and biopharmaceutics review(s). 2016. [Available from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761034orig1s000clinpharmr.pdf].

Peer CJ, Zimmerman SM, Figg WD, Goldstein DA, Ratain MJ. Subcutaneous atezolizumab: a jab without a benefit. Clin Pharmacol Drug Dev. 2022;11(1):134–5.

Article  CAS  PubMed  Google Scholar 

Willmann S, Höhn K, Edginton A, Sevestre M, Solodenko J, Weiss W, et al. Development of a physiology-based whole-body population model for assessing the influence of individual variability on the pharmacokinetics of drugs. J Pharmacokinet Pharmacodyn. 2007;34(3):401–31.

Article  PubMed  Google Scholar 

Bureau USC. QuickFacts - Population estimates 2023 [Available from:https://www.census.gov/quickfacts/fact/tableUS/PST045223.

Seidell JC. Epidemiology of obesity. Semin Vasc Med. 2005;5(1):3–14.

Article  PubMed  Google Scholar 

Wu B, Sternheim N, Agarwal P, Suchomel J, Vadhavkar S, Bruno R, et al. Evaluation of atezolizumab immunogenicity: clinical pharmacology (part 1). Clin Transl Sci. 2022;15(1):130–40.

Article  CAS  PubMed  Google Scholar 

Patel A, Hande V, Mr K, Dange H, Das AK, Murugesan V, et al. Effectiveness of immune checkpoint inhibitors in various tumor types treated by low, per-weight, and conventional doses at a tertiary care center in Mumbai. JCO Glob Oncol. 2024;10: e2300312.

Article  PubMed  PubMed Central  Google Scholar 

Agrawal S, Feng Y, Roy A, Kollia G, Lestini B. Nivolumab dose selection: challenges, opportunities, and lessons learned for cancer immunotherapy. J Immunother Cancer. 2016;4:72.

Article  PubMed  PubMed Central  Google Scholar 

Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014;515(7528):563–7.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Powles T, Eder JP, Fine GD, Braiteh FS, Loriot Y, Cruz C, et al. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature. 2014;515(7528):558–62.

Article  CAS  PubMed  Google Scholar 

Chou CH, Hsu LF. Model-based simulation to support the extended dosing regimens of atezolizumab. Eur J Clin Pharmacol. 2021;77(1):87–93.

Article  CAS  PubMed  Google Scholar 

Stroh M, Winter H, Marchand M, Claret L, Eppler S, Ruppel J, et al. Clinical pharmacokinetics and pharmacodynamics of atezolizumab in metastatic urothelial carcinoma. Clin Pharmacol Ther. 2017;102(2):305–12.

Article  CAS  PubMed  Google Scholar 

Datta-Mannan A, Estwick S, Zhou C, Choi H, Douglass NE, Witcher DR, et al. Influence of physiochemical properties on the subcutaneous absorption and bioavailability of monoclonal antibodies. MAbs. 2020;12(1):1770028.

Article  PubMed  PubMed Central  Google Scholar 

Peer CJ, Schmidt KT, Arisa O, Richardson WJ, Paydary K, Goldstein DA, et al. In silico re-optimization of atezolizumab dosing using population pharmacokinetic simulation and exposure-response simulation. J Clin Pharmacol. 2023;63(6):672–80.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Marolleau S, Mogenet A, Boeri C, Hamimed M, Ciccolini J, Greillier L. Killing a fly with a sledgehammer: atezolizumab exposure in real-world lung cancer patients. CPT Pharmacometr Syst Pharmacol. 2023;12(11):1795–803.

Article  CAS  Google Scholar