Phase I pharmacokinetic, safety, and preliminary efficacy study of tiragolumab in combination with atezolizumab in Chinese patients with advanced solid tumors

Zou H, Li Z, Tian X, Ren Y (2022) The top 5 causes of death in China from 2000 to 2017. Sci Rep 12(1):8119. https://doi.org/10.1038/s41598-022-12256-8

Article  ADS  CAS  PubMed  PubMed Central  Google Scholar 

Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W (2022) Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 135(5):584–590. https://doi.org/10.1097/cm9.0000000000002108

Article  PubMed  Google Scholar 

Pilleron S, Sarfati D, Janssen-Heijnen M, Vignat J, Ferlay J, Bray F, Soerjomataram I (2019) Global cancer incidence in older adults, 2012 and 2035: a population-based study. Int J Cancer 144(1):49–58. https://doi.org/10.1002/ijc.31664

Article  CAS  PubMed  Google Scholar 

Tang W, Huang Y, Zhou D, Huang Y, Chen Y, Ren S, Li Y, Wu S, Zhao X, Song X, Wang H, Jin Y, Yu H, Zhang L, Li Y, Boulton D, Shen K (2021) Evolving drug regulatory landscape in China: a clinical pharmacology perspective. Clin Transl Sci 14(4):1222–1230. https://doi.org/10.1111/cts.12987

Article  PubMed  PubMed Central  Google Scholar 

Chen C, Lou N, Zheng X, Wang S, Chen H, Han X (2021) Trends of phase I clinical trials of new drugs in mainland China over the past 10 years (2011–2020). Front Med 8:777698. https://doi.org/10.3389/fmed.2021.777698

Article  Google Scholar 

Fang W, Zhao S, Zhang Y, Ma Y, Zhao H, Zhang L (2019) Ongoing phase I studies of immune checkpoint inhibitors in China. Oncologist 24(Suppl 1):S11–S20. https://doi.org/10.1634/theoncologist.2019-io-s1-s03

Article  PubMed  PubMed Central  Google Scholar 

Mokhtari RB, Sambi M, Qorri B, Baluch N, Ashayeri N, Kumar S, Cheng H-LM, Yeger H, Das B, Szewczuk MR (2021) The next-generation of combination cancer immunotherapy: epigenetic immunomodulators transmogrify immune training to enhance immunotherapy. Cancers 13(14):3596. https://doi.org/10.3390/cancers13143596

Article  CAS  PubMed  PubMed Central  Google Scholar 

Setlai BP, Hull R, Bida M, Durandt C, Mulaudzi TV, Chatziioannou A, Dlamini Z (2022) Immunosuppressive signaling pathways as targeted cancer therapies. Biomedicines 10(3):682. https://doi.org/10.3390/biomedicines10030682

Article  CAS  PubMed  PubMed Central  Google Scholar 

Manieri NA, Chiang EY, Grogan JL (2017) TIGIT: a key inhibitor of the cancer immunity cycle. Trends Immunol 38(1):20–28. https://doi.org/10.1016/j.it.2016.10.002

Article  CAS  PubMed  Google Scholar 

Johnston RJ, Comps-Agrar L, Hackney J, Yu X, Huseni M, Yang Y, Park S, Javinal V, Chiu H, Irving B, Eaton D, Grogan J (2014) The immunoreceptor TIGIT regulates antitumor and antiviral CD8(+) T cell effector function. Cancer Cell 26(6):923–937. https://doi.org/10.1016/j.ccell.2014.10.018

Article  CAS  PubMed  Google Scholar 

Chiang EY, Mellman I (2022) TIGIT-CD226-PVR axis: advancing immune checkpoint blockade for cancer immunotherapy. J Immunother Cancer 10(4):e004711. https://doi.org/10.1136/jitc-2022-004711

Article  PubMed  PubMed Central  Google Scholar 

Kim TW, Bedard PL, LoRusso P, Gordon MS, Bendell J, Oh D-Y, Ahn M-J, Garralda E, D’Angelo SP, Desai J, Hodi FS, Wainberg Z, Delord J-P, Cassier PA, Cervantes A, Gil-Martin M, Wu B, Patil NS, Jin Y, Hoang T, Mendus D, Wen X, Meng R, Cho BC (2023) Anti-TIGIT antibody tiragolumab alone or with atezolizumab in patients with advanced solid tumors: a phase 1a/1b nonrandomized controlled trial. JAMA Oncol 9(11):1574–1582. https://doi.org/10.1001/jamaoncol.2023.3867

Article  PubMed  PubMed Central  Google Scholar 

Chauvin J-M, Pagliano O, Fourcade J, Sun Z, Wang H, Sander C, Kirkwood JM, Chen T-HT, Maurer M, Korman AJ, Zarour HM (2015) TIGIT and PD-1 impair tumor antigen–specific CD8+ T cells in melanoma patients. J Clin Invest 125(5):2046–2058. https://doi.org/10.1172/JCI80445

Article  PubMed  PubMed Central  Google Scholar 

Garralda E, Oh DY, Italiano A, Bedard PL, Delord JP, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez-Vida A, Shemesh CS, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho BC, Kim TW, Wu B (2023) Pharmacokinetics (PK) of tiragolumab in first-in-human study in patients with mixed solid tumors (GO30103). J Clin Pharmacol (Online ahead of print). https://doi.org/10.1002/jcph.2397

Article  Google Scholar 

Cho BC, Abreu DR, Hussein M, Cobo M, Patel AJ, Secen N, Lee KH, Massuti B, Hiret S, Yang JCH, Barlesi F, Lee DH, Ares LP, Hsieh RW, Patil NS, Twomey P, Yang X, Meng R, Johnson ML (2022) Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol 23(6):781–792. https://doi.org/10.1016/S1470-2045(22)00226-1

Article  CAS  PubMed  Google Scholar 

Stroh M, Winter H, Marchand M, Claret L, Eppler S, Ruppel J, Abidoye O, Teng SL, Lin WT, Dayog S, Bruno R, Jin J, Girish S (2017) Clinical pharmacokinetics and pharmacodynamics of atezolizumab in metastatic urothelial carcinoma. Clin Pharmacol Ther 102(2):305–312. https://doi.org/10.1002/cpt.587

Article  CAS  PubMed  Google Scholar 

Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS (2019) ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant 25(4):625–638. https://doi.org/10.1016/j.bbmt.2018.12.758

Article  CAS  PubMed  Google Scholar 

Cáceres MC, Guerrero-Martín J, Pérez-Civantos D, Palomo-López P, Delgado-Mingorance JI, Durán-Gómez N (2019) The importance of early identification of infusion-related reactions to monoclonal antibodies. Ther Clin Risk Manag 15:965–977. https://doi.org/10.2147/TCRM.S204909

Article  PubMed  PubMed Central  Google Scholar 

Niu J, Maurice-Dror C, Lee DH, Kim DW, Nagrial A, Voskoboynik M, Chung HC, Mileham K, Vaishampayan U, Rasco D, Golan T, Bauer TM, Jimeno A, Chung V, Chartash E, Lala M, Chen Q, Healy JA, Ahn MJ (2022) First-in-human phase 1 study of the anti-TIGIT antibody vibostolimab as monotherapy or with pembrolizumab for advanced solid tumors, including non-small-cell lung cancer. Ann Oncol 33(2):169–180. https://doi.org/10.1016/j.annonc.2021.11.002

Article  CAS  PubMed  Google Scholar 

Mettu NB, Ulahannan SV, Bendell JC, Garrido-Laguna I, Strickler JH, Moore KN, Stagg R, Kapoun AM, Faoro L, Sharma S (2022) A phase 1a/b open-label, dose-escalation study of etigilimab alone or in combination with nivolumab in patients with locally advanced or metastatic solid tumors. Clin Cancer Res 28(5):882–892. https://doi.org/10.1158/1078-0432.ccr-21-2780

Article  CAS  PubMed  Google Scholar 

Dumbrava E, Rasco D, Patnaik A, Vaena D, Papadopoulos K, ElNaggar A, Adewoye A, Smith R, Ferré P, Vaknin I, Devarakonda S, Sharma M (2021) 477 COM902 (anti-TIGIT antibody) monotherapy – preliminary evaluation of safety, tolerability, pharmacokinetics and receptor occupancy in patients with advanced solid tumors (NCT04354246). J Immunother Cancer 9(Suppl 2):A507. https://doi.org/10.1136/jitc-2021-SITC2021.477

Article  Google Scholar 

Dumbrava E, Sharma M, Fleming G, Papadopoulos K, Sullivan R, Vaena D, Patnaik A, ElNaggar A, Adewoye A, Smith R, Ferré P, Barbiro I, Lim E, Rasco D (2021) 478 COM701 in combination with BMS-986207 (anti-TIGIT antibody) and nivolumab—preliminary results of safety, tolerability and pharmacokinetics in patients with advanced solid tumors (NCT04570839). J Immunother Cancer 9(Suppl 2):A508. https://doi.org/10.1136/jitc-2021-SITC2021.478

Article  Google Scholar 

Johnson ML, Fox W, Lee Y-G, Lee KH, Ahn HK, Kim Y-C, Lee K-Y, Lee J-S, He X, Park C, Pomponio D, Dang T, Phuong PH, Nuyten DSA, Hegde AM, Joshi R (2022) ARC-7: randomized phase 2 study of domvanalimab + zimberelimab ± etrumadenant versus zimberelimab in first-line, metastatic, PD-L1-high non-small cell lung cancer (NSCLC). J Clin Oncol 40(36_suppl):397600. https://doi.org/10.1200/JCO.2022.40.36_suppl.397600

Article  Google Scholar 

Yu Y, Huang D, Gao B, Zhao J, Hu Y, Zhuang W, Kao S, Xu W, Yao Y, Yang T, Lee Y, Kim J, Shiah H, Wang R, Zheng H, Tan W, Gao R, Kim HR, Lu S (2022) 1017P - AdvanTIG-105: phase Ib dose-expansion study of ociperlimab (OCI) + tislelizumab (TIS) with chemotherapy (chemo) in patients (pts) with metastatic squamous (sq) and non-squamous (non-sq) non-small cell lung cancer (NSCLC). Ann Oncol 33:S1019. https://doi.org/10.1016/j.annonc.2022.07.1143

Article  Google Scholar 

Cuende J, Preillon J, Noemie W, Mercier M, Tieppo P, Welsby I, Bodo V, McGrath Y, Van Den Mooter TF, Machiels J-P, Truong C, De Henau O, Driessens G, Libouban M (2022) Pharmacodynamic assessment of a-TIGIT mAb EOS-448 highlights multiple FcγR-mediated mode-of-actions in blood and tumor of patients with advanced solid tumors. Cancer Res 82(12_Suppl):LB189. https://doi.org/10.1158/1538-7445.AM2022-LB189

Article  Google Scholar 

Gill KL, Machavaram KK, Rose RH, Chetty M (2016) Potential sources of inter-subject variability in monoclonal antibody pharmacokinetics. Clin Pharmacokinet 55(7):789–805. https://doi.org/10.1007/s40262-015-0361-4

Article  CAS  PubMed  Google Scholar 

Zhang J, Cai J, Bello A, Roy A, Sheng J (2019) Model-based population pharmacokinetic analysis of nivolumab in chinese patients with previously treated advanced solid tumors, including non–small cell lung cancer. J Clin Pharmacol 59(10):1415–1424. https://doi.org/10.1002/jcph.1432

Article  CAS  PubMed  PubMed Central  Google Scholar 

Shang J, Huang L, Huang J, Ren X, Liu Y, Feng Y (2022) Population pharmacokinetic models of anti-PD-1 mAbs in patients with multiple tumor types: a systematic review. Front Immunol 13:871372. https://doi.org/10.3389/fimmu.2022.871372

Article  CAS  PubMed  PubMed Central  Google Scholar 

Rudin CM, Liu SV, Soo RA, Lu S, Hong MH, Lee J-S, Bryl M, Dumoulin DW, Rittmeyer A, Chiu C-H, Ozyilkan O, Johnson M, Navarro A, Novello S, Ozawa Y, Tam SH, Patil NS, Wen X, Huang M, Hoang T, Meng R, Reck M (2022) SKYSCRAPER-02: tiragolumab in combination with atezolizumab plus chemotherapy in untreated extensive-stage small-cell lung cancer. J Clin Oncol 42(3):324–335. https://doi.org/10.1200/JCO.23.01363

Article  CAS  Google Scholar 

Hsu C-H, Lu Z, Gao S, Wang J-Y, Sun J-M, Liu T, Fan Q, Cai J, Ge F, Li S, Zhang L, Cha E, Lin S (2024) SKYSCRAPER-08: A phase III, randomized, double-blind, placebo-controlled study of first-line (1L) tiragolumab (tira) + atezolizumab (atezo) and chemotherapy (CT) in patients (pts) with esophageal squamous cell carcinoma (ESCC). JCO 42:245–245. https://doi.org/10.1200/JCO.2024.42.3_suppl.245

留言 (0)

沒有登入
gif