Second-line chemoimmunotherapy with nivolumab and paclitaxel in immune-related biomarker-enriched advanced gastric cancer: a multicenter phase Ib/II study

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424.

Article  PubMed  Google Scholar 

Hong S, Won YJ, Park YR, Jung KW, Kong HJ, Lee ES, et al. Cancer statistics in Korea: incidence, mortality, survival, and prevalence in 2017. Cancer Res Treat. 2020;52(2):335–50.

Article  PubMed  PubMed Central  Google Scholar 

Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224–35.

Article  CAS  PubMed  Google Scholar 

Satoh T, Xu RH, Chung HC, Sun GP, Doi T, Xu JM, et al. Lapatinib plus paclitaxel versus paclitaxel alone in the second-line treatment of HER2-amplified advanced gastric cancer in Asian populations: TyTAN–a randomized, phase III study. J Clin Oncol. 2014;32(19):2039–49.

Article  CAS  PubMed  Google Scholar 

Bang YJ, Xu RH, Chin K, Lee KW, Park SH, Rha SY, et al. Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(12):1637–51.

Article  CAS  PubMed  Google Scholar 

Lee J, Kim ST, Kim K, Lee H, Kozarewa I, Mortimer PGS, et al. Tumor genomic profiling guides patients with metastatic gastric cancer to targeted treatment: the VIKTORY umbrella trial. Cancer Discov. 2019;9(10):1388–405.

Article  CAS  PubMed  Google Scholar 

Lorenzen S, Knorrenschild JR, Pauligk C, Hegewisch-Becker S, Seraphin J, Thuss-Patience P, et al. Phase III randomized, double-blind study of paclitaxel with and without everolimus in patients with advanced gastric or esophagogastric junction carcinoma who have progressed after therapy with a fluoropyrimidine/platinum-containing regimen (RADPAC). Int J Cancer. 2020;147(9):2493–502.

Article  CAS  PubMed  Google Scholar 

Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, et al. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;390(10111):2461–71.

Article  CAS  PubMed  Google Scholar 

Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, et al. Safety and efficacy of pembrolizumab monotherapy in patients with previously treated advanced gastric and gastroesophageal junction cancer: phase 2 clinical KEYNOTE-059 trial. JAMA Oncol. 2018;4(5): e180013.

Article  PubMed  PubMed Central  Google Scholar 

Shitara K, Ozguroglu M, Bang YJ, Di Bartolomeo M, Mandala M, Ryu MH, et al. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. Lancet. 2018;392(10142):123–33.

Article  CAS  PubMed  Google Scholar 

Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021;398(10294):27–40.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, et al. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022. https://doi.org/10.1016/S1470-2045(21)00692-6.

Article  PubMed  Google Scholar 

Janjigian YY, Kawazoe A, Yanez P, Li N, Lonardi S, Kolesnik O, et al. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021. https://doi.org/10.1038/s41586-021-04161-3.

Article  PubMed  PubMed Central  Google Scholar 

Shitara K, Lordick F, Bang YJ, Enzinger P, Ilson D, Shah MA, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023;401(10389):1655–68.

Article  CAS  PubMed  Google Scholar 

Shah MA, Shitara K, Ajani JA, Bang YJ, Enzinger P, Ilson D, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023. https://doi.org/10.1038/s41591-023-02465-7.

Article  PubMed  PubMed Central  Google Scholar 

Shitara K, Van Cutsem E, Bang YJ, Fuchs C, Wyrwicz L, Lee KW, et al. Efficacy and safety of pembrolizumab or pembrolizumab plus chemotherapy vs chemotherapy alone for patients with first-line, advanced gastric cancer: the KEYNOTE-062 phase 3 randomized clinical trial. JAMA Oncol. 2022. https://doi.org/10.1001/jamaoncol.2020.3370.

Article  PubMed  PubMed Central  Google Scholar 

Kim ST, Cristescu R, Bass AJ, Kim KM, Odegaard JI, Kim K, et al. Comprehensive molecular characterization of clinical responses to PD-1 inhibition in metastatic gastric cancer. Nat Med. 2018;24(9):1449–58.

Article  CAS  PubMed  Google Scholar 

Lee CK, Kim HS, Jung M, Kim H, Bae WK, Koo DH, et al. Open-Label, Multicenter, Randomized, Biomarker-Integrated Umbrella Trial for Second-Line Treatment of Advanced Gastric Cancer: K-Umbrella Gastric Cancer Study. J Clin Oncol. 2023:JCO2300971. https://doi.org/10.1200/JCO.23.00971

Kwon WS, Che J, Rha SY, Chung HC, Han HJ, Kim J, et al. Development and validation of a targeted sequencing panel for application to treatment-refractory solid tumor. J Clin Oncol. 2021;39(3 Suppl):245.

Article  Google Scholar 

Sanchez-Vega F, Mina M, Armenia J, Chatila WK, Luna A, La KC, et al. Oncogenic signaling pathways in the cancer genome atlas. Cell. 2018;173(2):321-37 e10.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bigot F, Castanon E, Baldini C, Hollebecque A, Carmona A, Postel-Vinay S, et al. Prospective validation of a prognostic score for patients in immunotherapy phase I trials: the gustave roussy immune score (GRIm-score). Eur J Cancer. 2017;84:212–8.

Article  CAS  PubMed  Google Scholar 

Chowell D, Morris LGT, Grigg CM, Weber JK, Samstein RM, Makarov V, et al. Patient HLA class I genotype influences cancer response to checkpoint blockade immunotherapy. Science. 2018;359(6375):582–7.

Article  CAS  PubMed  Google Scholar 

Xu RH, Zhang Y, Pan H, Feng J, Zhang T, Liu T, et al. Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): a randomised, multicentre, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021;6:1015–24.

Article  PubMed  Google Scholar 

Nakajima TE, Kadowaki S, Minashi K, Nishina T, Yamanaka T, Hayashi Y, et al. Multicenter phase I/II Study of nivolumab combined with paclitaxel plus ramucirumab as second-line treatment in patients with advanced gastric cancer. Clin Cancer Res. 2021;27(4):1029–36.

Article  CAS  PubMed  Google Scholar 

Lee WS, Yang H, Chon HJ, Kim C. Combination of anti-angiogenic therapy and immune checkpoint blockade normalizes vascular-immune crosstalk to potentiate cancer immunity. Exp Mol Med. 2020;52(9):1475–85.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kubota Y, Kawazoe A, Sasaki A, Mishima S, Sawada K, Nakamura Y, et al. The impact of molecular subtype on efficacy of chemotherapy and checkpoint inhibition in advanced gastric cancer. Clin Cancer Res. 2020;26(14):3784–90.

Article  CAS  PubMed  Google Scholar 

Sun YT, Guan WL, Zhao Q, Wang DS, Lu SX, He CY, et al. PD-1 antibody camrelizumab for epstein-barr virus-positive metastatic gastric cancer: a single-arm, open-label, phase 2 trial. Am J Cancer Res. 2021;11(10):5006–15.

CAS  PubMed  PubMed Central  Google Scholar 

Rha SY, Lee C-k, Kim HS, Kang B, Jung M, Kwon WS, et al. A multi-institutional phase Ib/II trial of first-line triplet regimen (Pembrolizumab, Trastuzumab, Chemotherapy) for HER2-positive advanced gastric and gastroesophageal junction cancer (PANTHERA Trial): Molecular profiling and clinical update. J Clin Oncol. 2021;39(3 Suppl):218.

Article  Google Scholar 

Stutvoet TS, Kol A, de Vries EG, de Bruyn M, Fehrmann RS, Terwisscha van Scheltinga AG, et al. MAPK pathway activity plays a key role in PD-L1 expression of lung adenocarcinoma cells. J Pathol. 2019;249(1):52–64.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Garcia-Aranda M, Redondo M. Targeting protein kinases to enhance the response to anti-PD-1/PD-L1 immunotherapy. Int J Mol Sci. 2019;20(9):2296.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Wang JY, Xiu J, Baca Y, Arai H, Battaglin F, Kawanishi N, et al. Distinct genomic landscapes of gastroesophageal adenocarcinoma depending on PD-L1 expression identify mutations in RAS-MAPK pathway and TP53 as potential predictors of immunotherapy efficacy. Ann Oncol. 2021;32(7):906–16.

Article  CAS  PubMed  Google Scholar 

Pan JW, Zabidi MMA, Chong BK, Meng MY, Ng PS, Hasan SN, et al. Germline APOBEC3B deletion increases somatic hypermutation in Asian breast cancer that is associated with Her2 subtype, PIK3CA mutations, and immune activation. Int J Cancer. 2021. https://doi.org/10.1002/ijc.33463.

Article  PubMed  Google Scholar 

Sette A, Sidney J. HLA supertypes and supermotifs: a functional perspective on HLA polymorphism. Curr Opin Immunol. 1998;10(4):478–82.

Article  CAS  PubMed  Google Scholar 

Abed A, Calapre L, Lo J, Correia S, Bowyer S, Chopra A, et al. Prognostic value of HLA-I homozygosity in patients with non-small cell lung cancer treated with single agent immunotherapy. J Immunother Cancer. 2020;8(2): e001620.

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