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REVIEW

Evaluating the Therapeutic Potential of Durvalumab in Adults with Locally Advanced or Metastatic Biliary Tract Cancer: Evidence to Date

ORCID Icon, ORCID Icon & ORCID Icon
Pages 383-394 | Received 17 Jan 2024, Accepted 06 May 2024, Published online: 17 May 2024

References

  • Baria K, De Toni EN, Yu B, et al. Worldwide incidence and mortality of biliary tract cancer. Gastro Hep Adv. 2022;1(4):618–626. doi:10.1016/j.gastha.2022.04.007
  • Ellington TD, Momin B, Wilson RJ, et al. Incidence and mortality of cancers of the biliary tract, gallbladder, and liver by sex, age, race/ethnicity, and stage at diagnosis: United States, 2013 to 2017. Cancer Epidemiol Biomarkers Prev. 2021;30(9):1607–1614. doi:10.1158/1055-9965.EPI-21-0265
  • Jiang Y, Jiang L, Li F, et al. The epidemiological trends of biliary tract cancers in the United States of America. BMC Gastroenterol. 2022;22(1):22. doi:10.1186/s12876-022-02094-3
  • Tella SH, Wieczorek M, Hodge D, et al. A glimpse into the future of cholangiocarcinoma: predicting the future incidence based on the current epidemiological data. J Clin Oncol. 2023;41(4_suppl):616. doi:10.1200/JCO.2023.41.4_suppl.616
  • Valle J, Wasan H, Palmer DH, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010;362:1273–1281.
  • Shroff RT, Guthrie KA, Scott AJ, et al. SWOG 1815: a Phase III randomized trial of gemcitabine, cisplatin, and nab-paclitaxel versus gemcitabine and cisplatin in newly diagnosed, advanced biliary tract cancers. J Clin Oncol. 2023;41(4_suppl):LBA490–LBA490. doi:10.1200/JCO.2023.41.4_suppl.LBA490
  • marc PJ, Desrame J, Edeline J, et al. Modified FOLFIRINOX Versus CISGEM chemotherapy for patients with advanced biliary tract cancer (PRODIGE 38 AMEBICA): a Randomized Phase II study. J Clin Oncol. 2022;40(3):262–271. doi:10.1200/JCO.21.00679
  • Finn RS, Qin S, Ikeda M, et al. Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma. N Engl J Med. 2020;382(20):1894–1905. doi:10.1056/NEJMoa1915745
  • Abou-Alfa GK, Chan SL, Kudo M, et al. Phase 3 randomized, open-label, multicenter study of tremelimumab (T) and durvalumab (D) as first-line therapy in patients (pts) with unresectable hepatocellular carcinoma (uHCC): HIMALAYA. J Clin Oncol. 2022;40(4_suppl):379. doi:10.1200/JCO.2022.40.4_suppl.379
  • Greten TF, Schwabe R, Bardeesy N, et al. Immunology and immunotherapy of cholangiocarcinoma. Nat Rev Gastroenterol Hepatol. 2023;20(6):349–365. doi:10.1038/s41575-022-00741-4
  • Zhou G, Sprengers D, Mancham S, et al. Reduction of immunosuppressive tumor microenvironment in cholangiocarcinoma by ex vivo targeting immune checkpoint molecules. J Hepatol. 2019;71(4):753–762. doi:10.1016/j.jhep.2019.05.026
  • Llovet JM, Castet F, Heikenwalder M, et al. Immunotherapies for hepatocellular carcinoma. Nat Rev Clin Oncol. 2022;19(3):151–172. doi:10.1038/s41571-021-00573-2
  • Dunn C, Peppa D, Khanna P, et al. Temporal analysis of early immune responses in patients with acute hepatitis B virus infection. Gastroenterology. 2009;137(4):1289–1300. doi:10.1053/j.gastro.2009.06.054
  • Dustin LB. Innate and adaptive immune responses in chronic HCV infection. Curr Drug Targets. 2017;18(7):826–843. doi:10.2174/1389450116666150825110532
  • Gao M, Huang A, Sun Z, et al. Granulocytic myeloid-derived suppressor cell population increases with the severity of alcoholic liver disease. J Cell Mol Med. 2019;23(3):2032–2041. doi:10.1111/jcmm.14109
  • Job S, Rapoud D, Dos Santos A, et al. Identification of four immune subtypes characterized by distinct composition and functions of tumor microenvironment in intrahepatic cholangiocarcinoma. Hepatology. 2020;72(3):965–981. doi:10.1002/hep.31092
  • Nakamura H, Arai Y, Totoki Y, et al. Genomic spectra of biliary tract cancer. Nat Genet. 2015;47(9):1003–1010. doi:10.1038/ng.3375
  • Sabbatino F, Villani V, Yearley JH, et al. PD-L1 and HLA Class I Antigen Expression and Clinical Course of the Disease in Intrahepatic Cholangiocarcinoma. Clin Cancer Res. 2016;22(2):470–478. doi:10.1158/1078-0432.CCR-15-0715
  • Sun D, Ma J, Wang J, et al. Anti-PD-1 therapy combined with chemotherapy in patients with advanced biliary tract cancer. Cancer Immunol Immunother. 2019;68(9):1527–1535. doi:10.1007/s00262-019-02386-w
  • Ricci AD, D’alessandro R, Rizzo A, et al. Durvalumab in advanced cholangiocarcinoma: is someone knocking down the door? Immunotherapy. 2023;15(7):477–486. doi:10.2217/imt-2022-0301
  • Apetoh L, Ladoire S, Coukos G, et al. Combining immunotherapy and anticancer agents: the right path to achieve cancer cure? Ann Oncol off J Eur Soc Med Oncol. 2015;26(9):1813–1823. doi:10.1093/annonc/mdv209
  • Fournier C, Rivera Vargas T, Martin T, et al. Immunotherapeutic properties of chemotherapy. Curr Opin Pharmacol. 2017;35:83–88. doi:10.1016/j.coph.2017.05.003
  • Stewart R, Morrow M, Hammond SA, et al. Identification and Characterization of MEDI4736, an Antagonistic Anti-PD-L1 Monoclonal Antibody. Cancer Immunol Res. 2015;3(9):1052–1062. doi:10.1158/2326-6066.CIR-14-0191
  • Lutzky J, Antonia SJ, Blake-Haskins A, et al. A phase 1 study of MEDI4736, an anti–PD-L1 antibody, in patients with advanced solid tumors. J Clin Oncol. 2014;32(15_suppl):3001. doi:10.1200/jco.2014.32.15_suppl.3001
  • Oh DY, Lee KH, Lee DW, et al. Gemcitabine and cisplatin plus durvalumab with or without tremelimumab in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, single-centre, phase 2 study. lancet Gastroenterol Hepatol. 2022;7(6):522–532. doi:10.1016/S2468-1253(22)00043-7
  • D-Y O, Ruth A, Qin S, et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. NEJM Evid. 2022;3:1.
  • Rimini M, Fornaro L, Lonardi S, et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: an early exploratory analysis of real-world data. Liver Int. 2023;43(8):1803–1812. doi:10.1111/liv.15641
  • D-Y O, He AR, Qin S, et al. Updated overall survival (OS) from the phase III TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in patients (pts) with advanced biliary tract cancer (BTC). Ann Oncol. 2022;33:S1462–S1463. doi:10.1016/j.annonc.2022.10.114
  • Valle JW, Qin S, Antonuzzo L, et al. Impact of mutation status on efficacy outcomes in TOPAZ-1: a phase III study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+GC) in advanced biliary tract cancer (BTC). Ann Oncol. 2022;33:S1457. doi:10.1016/j.annonc.2022.10.104
  • Burris III HA, Okusaka T, Vogel A. Patient-reported outcomes for the phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. J Clin Oncol. 2022;40(16_suppl):4070. doi:10.1200/JCO.2022.40.16_suppl.4070
  • Zhao Q, Xie R, Zhong W, et al. Cost-effectiveness analysis of adding durvalumab to chemotherapy as first-line treatment for advanced biliary tract cancer based on the TOPAZ-1 trial. Cost Eff Resour Alloc. 2023;21(1):21. doi:10.1186/s12962-023-00430-2
  • Ye ZM, Xu Z, Li H, et al. Cost-effectiveness analysis of durvalumab plus chemotherapy as first-line treatment for biliary tract cancer. Front Public Health. 2023;11:2.
  • Piha-Paul SA, Oh DY, Ueno M, et al. Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: results from the KEYNOTE −158 and KEYNOTE −028 studies. Int J Cancer. 2020;147(8):2190–2198. doi:10.1002/ijc.33013
  • Kelley RK, Ueno M, Yoo C, et al. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;401(10391):1853–1865. doi:10.1016/S0140-6736(23)00727-4
  • Ueno M, Ikeda M, Morizane C, et al. Nivolumab alone or in combination with cisplatin plus gemcitabine in Japanese patients with unresectable or recurrent biliary tract cancer: a non-randomised, multicentre, open-label, phase 1 study. lancet Gastroenterol Hepatol. 2019;4(8):611–621. doi:10.1016/S2468-1253(19)30086-X
  • Feng K, Liu Y, Zhao Y, et al. Efficacy and biomarker analysis of nivolumab plus gemcitabine and cisplatin in patients with unresectable or metastatic biliary tract cancers: results from a phase II study. J Immunother Cancer. 2020;8(1):e000367. doi:10.1136/jitc-2019-000367
  • Sahai V, Griffith KA, Beg MS, et al. A randomized phase 2 trial of nivolumab, gemcitabine, and cisplatin or nivolumab and ipilimumab in previously untreated advanced biliary cancer: bilT −01. Cancer. 2022;128(19):3523–3530. doi:10.1002/cncr.34394
  • Beri N. Immune checkpoint inhibitors in cholangiocarcinoma. Immunotherapy. 2023;15(7):541–551. doi:10.2217/imt-2022-0288
  • Maio M, Ascierto PA, Manzyuk L, et al. Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study. Ann Oncol off J Eur Soc Med Oncol. 2022;33(9):929–938. doi:10.1016/j.annonc.2022.05.519
  • Ahn S, chan LJ, Shin DW, et al. High PD-L1 expression is associated with therapeutic response to pembrolizumab in patients with advanced biliary tract cancer. Sci Rep. 2020;10(1):10. doi:10.1038/s41598-019-56089-4
  • Liddell SS, Chakrabarti S, Wintheiser GA, et al. Tumor mutational burden is a potential predictive biomarker for response to immune checkpoint inhibitors in patients with advanced biliary tract cancer. JCO Precis Oncol. 2022;6:2.
  • Rizzo A, Ricci AD, Brandi G. PD-L1, TMB, MSI, and other predictors of response to immune checkpoint inhibitors in biliary tract cancer. Cancers. 2021;13(3):1–11. doi:10.3390/cancers13030558
  • Frega G, Cossio FP, Banales JM, et al. Lacking immunotherapy biomarkers for biliary tract cancer: a comprehensive systematic literature review and meta-analysis. Cells. 2023;12(16):2098. doi:10.3390/cells12162098
  • Weinberg BA, Xiu J, Lindberg MR, et al. Molecular profiling of biliary cancers reveals distinct molecular alterations and potential therapeutic targets. J Gastrointest Oncol. 2019;10(4):652–662. doi:10.21037/jgo.2018.08.18
  • Zhou B, Gao Y, Zhang P, et al. Acquired resistance to immune checkpoint blockades: the underlying mechanisms and potential strategies. Front Immunol. 2021;2:12.
  • Rizzo A, Ricci AD, Brandi G. Durvalumab: an investigational anti-PD-L1 antibody for the treatment of biliary tract cancer. Expert Opin Investig Drugs. 2021;30(4):343–350. doi:10.1080/13543784.2021.1897102
  • Kim DW, Kim Y, Kovari BP, et al. Biomarker analysis from a phase II multi-institutional study of nivolumab in patients with advanced refractory biliary tract cancer. Eur J Cancer. 2022;176:171–180. doi:10.1016/j.ejca.2022.09.014
  • Chen X, Wang D, Liu J, et al. Genomic alterations in biliary tract cancer predict prognosis and immunotherapy outcomes. J Immunother Cancer. 2021;2:9.
  • Lo JH, Agarwal R, Goff LW, et al. Immunotherapy in biliary tract cancers: current standard-of-care and emerging strategies. Cancers. 2023;16(1):15. doi:10.3390/cancers16010015
  • Merters J, Lamarca A. Integrating cytotoxic, targeted and immune therapies for cholangiocarcinoma. J Hepatol. 2023;78(3):652–657. doi:10.1016/j.jhep.2022.11.005
  • Storandt MH, Kurniali PC, Mahipal A, et al. Targeted therapies in advanced cholangiocarcinoma. Life. 2023;13(10):2066. doi:10.3390/life13102066
  • Zhang W, Shi J, Wang Y, et al. Next-generation sequencing-guided molecular-targeted therapy and immunotherapy for biliary tract cancers. Cancer Immunol Immunother. 2021;70(4):1001–1014. doi:10.1007/s00262-020-02745-y
  • Demols A, Bucalau A-M, Mans L. The path to personalized treatment in advanced and metastatic biliary tract cancers: a review of new targeted therapies and immunotherapy. Curr Opin Oncol. 2022;34(4):403–411. doi:10.1097/CCO.0000000000000850
  • Dong X, Zhang Z, Zhang Q, et al. Triple therapy in biliary tract cancers: gemOX plus immune checkpoint inhibitor in combination with lenvatinib or NGS-guided targeted therapy. J Cancer Res Clin Oncol. 2023;149:1917–1927. doi:10.1007/s00432-022-04166-z
  • Zhang W, Xiang D, Lu C, et al. GemOX plus immune checkpoint inhibitor in combination with lenvatinib or NGS-guided targeted therapy in patients with biliary tract cancers. J Clin Oncol. 2022;40(16_suppl):e16133–e16133. doi:10.1200/JCO.2022.40.16_suppl.e16133
  • Zhang Q, Liu X, Wei S, et al. Lenvatinib plus PD-1 inhibitors as first-line treatment in patients with unresectable biliary tract cancer: a single-arm, open-label, phase II study. Front Oncol. 2021;3:11.
  • Lin J, Yang X, Long J, et al. Pembrolizumab combined with lenvatinib as non-first-line therapy in patients with refractory biliary tract carcinoma. Hepatobiliary Surg Nutr. 2020;9(4):414–424. doi:10.21037/hbsn-20-338
  • Shi C, Li Y, Yang C, et al. Lenvatinib plus programmed cell death protein-1 inhibitor beyond first-line systemic therapy in refractory advanced biliary tract cancer: a real-world retrospective study in China. Front Immunol. 2022;2:13.
  • Zhu C, Xue J, Wang Y, et al. Efficacy and safety of lenvatinib combined with PD-1/PD-L1 inhibitors plus Gemox chemotherapy in advanced biliary tract cancer. Front Immunol. 2023;2:14.
  • Doki Y, Ueno M, Hsu CH, et al. Tolerability and efficacy of durvalumab, either as monotherapy or in combination with tremelimumab, in patients from Asia with advanced biliary tract, esophageal, or head-and-neck cancer. Cancer Med. 2022;11(13):2550–2560. doi:10.1002/cam4.4593
  • Boilève A, Hilmi M, Gougis P, et al. Triplet combination of durvalumab, tremelimumab, and paclitaxel in biliary tract carcinomas: safety run-in results of the randomized IMMUNOBIL PRODIGE 57 phase II trial. Eur J Cancer. 2021;143:55–63. doi:10.1016/j.ejca.2020.10.027
  • Elias C, Zeidan YH, Bouferraa Y, et al. A phase II single arm study of Nivolumab with stereotactic Ablative radiation Therapy after induction chemotherapy in CHOlangiocarcinoma (NATCHO). BMC Cancer. 2022;22(1). doi:10.1186/s12885-022-10373-1
  • Maithel SK, Keilson JM, Cao HST, et al. NEO-GAP: a single-arm, phase II feasibility trial of neoadjuvant gemcitabine, cisplatin, and nab-paclitaxel for resectable, high-risk intrahepatic cholangiocarcinoma. Ann Surg Oncol. 2023;30(11):6558–6566. doi:10.1245/s10434-023-13809-5