Nghiên cứu Giai đoạn I/II để đánh giá dược lực học lâm sàng và độ an toàn của liều đơn gia tăng và nhiều liều PF-06881894 qua đường tiêm dưới da ở phụ nữ mắc ung thư vú không di căn xa
Tóm tắt
Đánh giá dược lực học (PD), dược động học (PK) và độ an toàn của liều đơn và nhiều liều PF-06881894 (pegfilgrastim-apgf; Nyvepria™), một thuốc tương tự sinh học của pegfilgrastim tham chiếu (Neulasta®), ở phụ nữ mắc ung thư vú di căn không xa.
Trong Giai đoạn I (Chu kỳ 0) của nghiên cứu Giai đoạn I/II này, đáp ứng PD (số lượng bạch cầu trung tính tuyệt đối [ANC]; số lượng CD34 + ), hồ sơ PK, và độ an toàn của một liều đơn 3 hoặc 6 mg PF-06881894 được đánh giá ở bệnh nhân chưa điều trị hóa trị trước khi phẫu thuật vú triệt để. Trong Giai đoạn II (Chu kỳ 1–4), đáp ứng PD (thời gian giảm bạch cầu trung tính nặng [DSN, Chu kỳ 1], ANC [Chu kỳ 1 và 4]) và hồ sơ PK (Chu kỳ 1 và 4) của liều đơn và nhiều liều 6 mg PF-06881894 sử dụng đồng thời với hóa trị và sau phẫu thuật vú triệt để được đánh giá.
Hai mươi lăm bệnh nhân (tuổi trung bình 59 năm) đã được ghi danh (Chu kỳ 0,
PF-06881894 dưới dạng một liều đơn 3 hoặc 6 mg trước phẫu thuật triệt để, hoặc nhiều liều 6 mg/cycle sau phẫu thuật, với/không có hóa trị ức chế tủy xương, nhất quán với dược lý lâm sàng và hồ sơ độ an toàn của pegfilgrastim tham chiếu.
Tháng 10 năm 2017. Mã số Đăng ký ClinicalTrials.gov: NCT02650193. Số EudraCT: 2015-002057-35.
Từ khóa
Tài liệu tham khảo
Lucas AJ, Olin JL, Coleman MD (2018) Management and preventive measures for febrile neutropenia. P T 43(4):228–232
Wang L, Baser O, Kutikova L, Page JH, Barron R (2015) The impact of primary prophylaxis with granulocyte colony-stimulating factors on febrile neutropenia during chemotherapy: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer 23(11):3131–3140. https://doi.org/10.1007/s00520-015-2686-9
Lyman GH, Dale DC, Culakova E, Poniewierski MS, Wolff DA, Kuderer NM, Huang M, Crawford J (2013) The impact of the granulocyte colony-stimulating factor on chemotherapy dose intensity and cancer survival: a systematic review and meta-analysis of randomized controlled trials. Ann Oncol: Off J Eur Soc Med Oncol 24(10):2475–2484. https://doi.org/10.1093/annonc/mdt226
Chambers P, Jani Y, Wei L, Kipps E, Forster MD, Wong ICK (2019) Patient factors and their impact on neutropenic events: a systematic review and meta-analysis. Support Care Cancer 27(7):2413–2424. https://doi.org/10.1007/s00520-019-04773-6
Lyman GH, Dale DC, Legg JC, Abella E, Morrow PK, Whittaker S, Crawford J (2015) Assessing patients’ risk of febrile neutropenia: is there a correlation between physician-assessed risk and model-predicted risk? Cancer Med 4(8):1153–1160. https://doi.org/10.1002/cam4.454
Smith TJ, Bohlke K, Lyman GH, Carson KR, Crawford J, Cross SJ, Goldberg JM, Khatcheressian JL, Leighl NB, Perkins CL, Somlo G, Wade JL, Wozniak AJ, Armitage JO, American Society of Clinical Oncology (2015) Recommendations for the use of WBC growth factors: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 33(28):3199–3212. https://doi.org/10.1200/JCO.2015.62.3488
Becker PS, Griffiths EA, Alwan LM, Bachiashvili K, Brown A, Cool R, Curtin P, Dinner S, Gojo I, Hicks A, Kallam A, Kidwai WZ, Kloth DD, Kraut EH, Landsburg D, Lyman GH, Miller R, Mukherjee S, Patel S, Perez LE, Poust A, Rampal R, Rosovsky R, Roy V, Rugo HS, Shayani S, Vasu S, Wadleigh M, Westbrook K, Westervelt P, Burns J, Keller J, Pluchino LA (2020) NCCN guidelines insights: hematopoietic growth factors, version 1.2020. J Natl Compr Canc Netw 18(1):12–22. https://doi.org/10.6004/jnccn.2020.0002
Shao L, Wang Y, Chang J, Luo Y, Meng A, Zhou D (2013) Hematopoietic stem cell senescence and cancer therapy-induced long-term bone marrow injury. Transl Cancer Res 2(5):397–411. https://doi.org/10.3978/j.issn.2218-676X.2013.07.03
Danova M, Antonuzzo A, Spandonaro F, Pronzato P (2020) Biosimilar pegfilgrastim and adherence to guidelines for chemotherapy-induced neutropenia and infections in cancer patients. Infez Med 28(1):127–129
National Comprehensive Cancer Network® (2020) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Myeloid growth factors (version 1.2017). https://www.nccn.org/professionals/physician_gls/default.aspx. Accessed 2 February 2021
Melhem M, Delor I, Perez-Ruixo JJ, Harrold J, Chow A, Wu L, Jacqmin P (2018) Pharmacokinetic-pharmacodynamic modelling of neutrophil response to G-CSF in healthy subjects and patients with chemotherapy-induced neutropenia. Br J Clin Pharmacol 84(5):911–925. https://doi.org/10.1111/bcp.13504
Lee J, Lee JE, Kim Z, Han SW, Hur SM, Kim SY, Lee MH, Lim CW (2018) Pegfilgrastim for primary prophylaxis of febrile neutropenia in breast cancer patients undergoing TAC chemotherapy. Ann Surg Treat Res 94(5):223–228. https://doi.org/10.4174/astr.2018.94.5.223
Li Y, Klippel Z, Shih X, Wang H, Reiner M, Page JH (2016) Trajectory of absolute neutrophil counts in patients treated with pegfilgrastim on the day of chemotherapy versus the day after chemotherapy. Cancer Chemother Pharmacol 77(4):703–712. https://doi.org/10.1007/s00280-016-2970-5
Cornes P, Gascon P, Vulto AG, Aapro M (2020) Biosimilar pegfilgrastim: improving access and optimising practice to supportive care that enables cure. BioDrugs 34(3):255–263. https://doi.org/10.1007/s40259-020-00411-4
Amgen Inc. (2019) NEULASTA® (pegfilgrastim) prescribing infomation. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s180lbl.pdf. Accessed 2 February 2021
Pfizer Inc. (2020) NYVEPRIA™ (pegfilgrastim-apgf) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761111lbl.pdf Accessed 2 February 2021
U.S. Food and Drug Administration (2015) Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed 2 February 2021
Molineux G (2004) The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta®). Curr Pharm Des 10(11):1235–1244. https://doi.org/10.2174/1381612043452613
Crawford J (2003) Safety and efficacy of pegfilgrastim in patients receiving myelosuppressive chemotherapy. Pharmacotherapy 23(8 Pt 2):15S–19S. https://doi.org/10.1592/phco.23.9.15s.32889
Aapro M, Boccia R, Leonard R, Camps C, Campone M, Choquet S, Danova M, Glaspy J, Hus I, Link H, Sliwa T, Tesch H, Valero V (2017) Refining the role of pegfilgrastim (a long-acting G-CSF) for prevention of chemotherapy-induced febrile neutropenia: consensus guidance recommendations. Support Care Cancer 25(11):3295–3304. https://doi.org/10.1007/s00520-017-3842-1
CLINICAL STUDY PROTOCOL (2015) ZIN-130-1504 A phase 1-2 ascending dose study to assess the pharmacodynamics, pharmacokinetics, and safety of HSP-130 in subjects with non-metastatic breast cancer following single-dose and multiple-dose administration by subcutaneous injection. https://clinicaltrials.gov/ProvidedDocs/93/NCT02650193/Prot_000.pdf
U.S. Food and Drug Administration (2001) Guidance for Industry: Bioanalytical Method Validation, May 2001. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CMV). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070107.pdf. Accessed 2 February 2021
U.S. Food and Drug Administration (2013) Guidance for industry: bioanalytical method validation,. September 2013. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CMV). https://www.regulations.gov/document?D=FDA-2013-D-1020-0002. Accessed 2 February 2021
Amgen Ltd. (2018) NEULASTA® (pegfilgrastim) summary of product characteristics. https://www.medicines.org.uk/emc/product/6770/smpc#DOCREVISION. Accessed 2 February 2021
Moosavi S, Borema T, Ewesuedo R, Harris S, Levy J, May TB, Summers M, Thomas JS, Zhang J, Yao HM (2020) PF-06881894, a proposed biosimilar to pegfilgrastim, versus US-licensed and EU-approved pegfilgrastim reference products (Neulasta®): pharmacodynamics, pharmacokinetics, immunogenicity, and safety of single or multiple subcutaneous doses in healthy volunteers. Adv Ther 37(7):3370–3391. https://doi.org/10.1007/s12325-020-01387-x
Johnston E, Crawford J, Blackwell S, Bjurstrom T, Lockbaum P, Roskos L, Yang BB, Gardner S, Miller-Messana MA, Shoemaker D, Garst J, Schwab G (2000) Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol 18(13):2522–2528. https://doi.org/10.1200/JCO.2000.18.13.2522
Brito M, Esteves S, Andre R, Isidoro M, Moreira A (2016) Comparison of effectiveness of biosimilar filgrastim (Nivestim), reference Amgen filgrastim and pegfilgrastim in febrile neutropenia primary prevention in breast cancer patients treated with neo(adjuvant) TAC: a non-interventional cohort study. Support Care Cancer 24(2):597–603. https://doi.org/10.1007/s00520-015-2818-2
Clemons M, Fergusson D, Simos D, Mates M, Robinson A, Califaretti N, Zibdawi L, Bahl M, Raphael J, Ibrahim MFK, Fernandes R, Pitre L, Aseyev O, Stober C, Vandermeer L, Saunders D, Hutton B, Mallick R, Pond GR, Awan A, Hilton J (2020) A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer. Ann Oncol: Off J Eur Soc Med Oncol 31(7):951–957. https://doi.org/10.1016/j.annonc.2020.04.005
Yang BB, Kido A, Shibata A (2007) Serum pegfilgrastim concentrations during recovery of absolute neutrophil count in patients with cancer receiving pegfilgrastim after chemotherapy. Pharmacotherapy 27(10):1387–1393. https://doi.org/10.1592/phco.27.10.1387
Cameron D (2009) Management of chemotherapy-associated febrile neutropenia. Br J Cancer 101(Suppl 1):18–22. https://doi.org/10.1038/sj.bjc.6605272
Crawford J, Dale DC, Lyman GH (2004) Chemotherapy-induced neutropenia. Cancer 100(2):228–237. https://doi.org/10.1002/cncr.11882
Moon JM, Chun BJ (2009) Predicting the complicated neutropenic fever in the emergency department. Emerg Med J 26(11):802–806. https://doi.org/10.1136/emj.2008.064865
Yang BB, Kido A (2011) Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet 50(5):295–306. https://doi.org/10.2165/11586040-000000000-00000
Yang BB, Savin MA, Green M (2012) Prevention of chemotherapy-induced neutropenia with pegfilgrastim: pharmacokinetics and patient outcomes. Chemotherapy 58(5):387–398. https://doi.org/10.1159/000345626
Li L, Ma L, Schrieber SJ, Rahman NA, Deisseroth A, Farrell AT, Wang Y, Sinha V, Marathe A (2018) Quantitative relationship between AUEC of absolute neutrophil count and duration of severe neutropenia for G-CSF in breast cancer patients. Clin Pharmacol Ther 104(4):742–748. https://doi.org/10.1002/cpt.991
Yang Q, Jacobs TM, McCallen JD, Moore DT, Huckaby JT, Edelstein JN, Lai SK (2016) Analysis of pre-existing IgG and IgM antibodies against polyethylene glycol (PEG) in the general population. Anal Chem 88(23):11804–11812. https://doi.org/10.1021/acs.analchem.6b03437
Wang Y, Chen L, Liu F, Zhao N, Xu L, Fu B, Li Y (2019) Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: a systematic review and Bayesian network meta-analysis. Sci Rep 9(1):15374. https://doi.org/10.1038/s41598-019-51982-4
Waller CF, Tiessen RG, Lawrence TE, Shaw A, Liu MS, Sharma R, Baczkowski M, Kothekar MA, Micales CE, Barve A, Ranganna GM, Pennella EJ (2018) A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim. J Cancer Res Clin Oncol 144(6):1087–1095. https://doi.org/10.1007/s00432-018-2643-3
Harbeck N, Wang J, Otto GP, Gattu S, Krendyukov A (2019) Safety analysis of proposed pegfilgrastim biosimilar in phase I and phase III studies. Future Oncol 15(12):1313–1322. https://doi.org/10.2217/fon-2018-0878
Bellon A, Wang J, Skerjanec A, Velinova M, Dickerson D, Sabet A, Ngo L, O’Reilly T, Tomek C, Schussler S, Schier-Mumzhiu S, Gattu S, Koch SD, Schelcher C, Dobreva M, Boldea A, Nakov R, Otto GP (2020) A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics. Br J Clin Pharmacol 86(6):1139–1149. https://doi.org/10.1111/bcp.14226
Botteri E, Krendyukov A, Curigliano G (2018) Comparing granulocyte colony-stimulating factor filgrastim and pegfilgrastim to its biosimilars in terms of efficacy and safety: a meta-analysis of randomised clinical trials in breast cancer patients. Eur J Cancer 89:49–55. https://doi.org/10.1016/j.ejca.2017.10.034
Desai K, Misra P, Kher S, Shah N (2018) Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy. Exp Hematol Oncol 7:22. https://doi.org/10.1186/s40164-018-0114-9
Kahan Z, Grecea D, Smakal M, Tjulandin S, Bondarenko I, Perjesi L, Illes A, Horvat-Karajz K, Aradi I (2019) Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy. BMC Cancer 19(1):122. https://doi.org/10.1186/s12885-019-5329-6
Kang KW, Lee BH, Jeon MJ, Yu ES, Kim DS, Lee SR, Sung HJ, Choi CW, Park Y, Kim BS (2020) Efficacy and safety of two pegfilgrastim biosimilars: tripegfilgrastim and pegteograstim. Cancer Med 9(17):6102–6110. https://doi.org/10.1002/cam4.3261
Waller CF, Ranganna GM, Pennella EJ, Blakeley C, Bronchud MH, Mattano LA Jr, Berzoy O, Voitko N, Shparyk Y, Lytvyn I, Rusyn A, Popov V, Láng I, Beckmann K, Sharma R, Baczkowski M, Kothekar M, Barve A (2019) Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia. Ann Hematol 98(5):1217–1224. https://doi.org/10.1007/s00277-019-03639-5
Zhou C, Huang Y, Wang D, An C, Zhou F, Li Y, Chen G, Wu C, He J, Wu G, Song X, Gao J, Liu W, Li B, Shi J, Huang C, Yu J, Feng J, Yue H, Shi M, Xia J (2016) A randomized multicenter phase iii study of single administration of mecapegfilgrastim (HHPG-19K), a pegfilgrastim biosimilar, for prophylaxis of chemotherapy-induced neutropenia in patients with advanced non-small-cell lung cancer (NSCLC). Clin Lung Cancer 17(2):119–127. https://doi.org/10.1016/j.cllc.2015.12.002