Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009;101(10):708–20.
Article PubMed PubMed Central Google Scholar
Eisenhauer EA, O’Dwyer PJ, Christian M, Humphrey JS. Phase I clinical trial design in cancer drug development. J Clin Oncol. 2000;18(3):684–92.
Article CAS PubMed Google Scholar
Optimizing Dosing in Oncology Drug Development. Friends of cancer research 2021. p. https://friendsofcancerresearch.org/sites/default/files/2021-11/Optimizing_Dosing_in_Oncology_Drug_Development.pdf.
Administration FaD. Project optimus: reforming the dose optimization and dose selection paradigm in oncology. 2022. 01/31/2022 [cited; Available from: https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus.
Shah M, Rahman A, Theoret MR, Pazdur R. The drug-dosing conundrum in oncology—when less is more. N Engl J Med. 2021;385(16):1445–7.
Tosi D, Laghzali Y, Vinches M, Alexandre M, Homicsko K, Fasolo A, et al. Clinical development strategies and outcomes in first-in-human trials of monoclonal antibodies. J Clin Oncol. 2015;33(19):2158–65.
Article CAS PubMed 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
Casneuf T, Xu XS, Adams HC 3rd, Axel AE, Chiu C, Khan I, et al. Effects of daratumumab on natural killer cells and impact on clinical outcomes in relapsed or refractory multiple myeloma. Blood Adv. 2017;1(23):2105–14.
Article CAS PubMed PubMed Central Google Scholar
Tang Y, Li X, Cao Y. Which factors matter the most? Revisiting and dissecting antibody therapeutic doses. Drug Discov Today. 2021;26(8):1980–90.
Article CAS PubMed PubMed Central Google Scholar
Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49(10):633–59.
Article CAS PubMed Google Scholar
Cella D, Motzer RJ, Suarez C, Blum SI, Ejzykowicz F, Hamilton M, et al. Patient-reported outcomes with first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma treated in CheckMate 9ER: an open-label, randomised, phase 3 trial. Lancet Oncol. 2022;23(2):292–303.
Article CAS PubMed PubMed Central Google Scholar
Ahamadi M, Freshwater T, Prohn M, Li CH, de Alwis DP, de Greef R, et al. Model-based characterization of the pharmacokinetics of pembrolizumab: a humanized anti-PD-1 monoclonal antibody in advanced solid tumors. CPT Pharmacometr Syst Pharmacol. 2017;6(1):49–57.
Dolgos H, Trusheim M, Gross D, Halle JP, Ogden J, Osterwalder B, et al. Translational Medicine Guide transforms drug development processes: the recent Merck experience. Drug Discov Today. 2016;21(3):517–26.
Conforti F, Pala L, Bagnardi V, De Pas T, Martinetti M, Viale G, et al. Cancer immunotherapy efficacy and patients’ sex: a systematic review and meta-analysis. Lancet Oncol. 2018;19(6):737–46.
Article CAS PubMed Google Scholar
Cai J, Chen H, Lu M, Zhang Y, Lu B, You L, et al. Advances in the epidemiology of pancreatic cancer: trends, risk factors, screening, and prognosis. Cancer Lett. 2021;1(520):1–11.
Lunsumio, INN-mosunetuzumab. https://www.ema.europa.eu/en/documents/product-information/lunsumio-epar-product-information_en.pdf. 2022.
Budde LE, Assouline S, Sehn LH, Schuster SJ, Yoon SS, Yoon DH, et al. Single-agent mosunetuzumab shows durable complete responses in patients with relapsed or refractory B-cell lymphomas: phase I dose-escalation study. J Clin Oncol. 2022;40(5):481–91.
Article CAS PubMed Google Scholar
Feng Y, Wang X, Bajaj G, Agrawal S, Bello A, Lestini B, et al. Nivolumab exposure–response analyses of efficacy and safety in previously treated squamous or nonsquamous non-small cell lung cancer. Clin Cancer Res. 2017;23(18):5394–405.
Article CAS PubMed Google Scholar
Wang Y, Booth B, Rahman A, Kim G, Huang SM, Zineh I. Toward greater insights on pharmacokinetics and exposure-response relationships for therapeutic biologics in oncology drug development. Clin Pharmacol Ther. 2017;101(5):582–4.
Article CAS PubMed Google Scholar
Clemens PL, Yan X, Lokhorst HM, Lonial S, Losic N, Khan I, et al. Pharmacokinetics of daratumumab following intravenous infusion in relapsed or refractory multiple myeloma after prior proteasome inhibitor and immunomodulatory drug treatment. Clin Pharmacokinet. 2017;56(8):915–24.
Article CAS PubMed Google Scholar
Bajaj G, Wang X, Agrawal S, Gupta M, Roy A, Feng Y. Model-based population pharmacokinetic analysis of nivolumab in patients with solid tumors. CPT Pharmacometr Syst Pharmacol. 2017;6(1):58–66.
Wang X, Feng Y, Bajaj G, Gupta M, Agrawal S, Yang A, et al. Quantitative characterization of the exposure-response relationship for cancer immunotherapy: a case study of nivolumab in patients with advanced melanoma. CPT Pharmacometr Syst Pharmacol. 2017;6(1):40–8.
Paci A, Desnoyer A, Delahousse J, Blondel L, Maritaz C, Chaput N, et al. Pharmacokinetic/pharmacodynamic relationship of therapeutic monoclonal antibodies used in oncology: part 1, monoclonal antibodies, antibody-drug conjugates and bispecific T-cell engagers. Eur J Cancer. 2020;128:107–18.
Article CAS PubMed Google Scholar
Labrijn AF, Janmaat ML, Reichert JM, Parren P. Bispecific antibodies: a mechanistic review of the pipeline. Nat Rev Drug Discov. 2019;18(8):585–608.
Article CAS PubMed Google Scholar
Dhillon S. Tebentafusp: first approval. Drugs. 2022.
留言 (0)