LBA53 Sintilimab plus chemotherapy (chemo) versus chemo as first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-16): First results of a randomized, double-blind, phase III study

Xu, Jianming; Jiang, Hong; Pan, Yueyin; Gu, Kai; Cang, Shundong; Han, Li; Shu, Yongqian; Li, J.; Zhao, Jiuda; Pan, Hongming; Luo, Suxia; Qin, Yanru; Guo, Qixin; Bai, Yu; Ye, Ling; Guo, Yu; Li, Z.; Liu, Y.; Wang, Y.; Hong-lin, Zhou

doi:10.1016/j.annonc.2021.08.2133

Cited by 110 publications

(96 citation statements)

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“…As presented at ESMO 2021, the first results show a survival benefit of the combination therapy in all randomized patients versus chemotherapy plus placebo (median OS 15.2 vs. 12.3 mths, HR 0.77 (95% CI 0.63-0.94), p = 0.0090). This effect was even more clear in the group of patients with PD-L1 CPS ≥ 5 tumors (median OS 18.4 vs. 12.9 mths (HR 0.66 (95% CI 0.51-0.86), p = 0.0023)) [23].…”

Section: Palliative First-line Therapymentioning

confidence: 89%

Immunotherapy in Gastric Cancer

Högner

Möhler

2022

Current Oncology

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Immune checkpoint inhibition is a new standard of targeted therapy in the treatment of advanced or metastatic gastric cancer (GC) and is represented in various combinations with and without chemotherapy in every therapy line within clinical trials. In advanced adenocarcinoma of GC, gastroesophageal junction cancer (GEJC) and esophageal cancer (EC), the combination of nivolumab and chemotherapy in first-line therapy improves overall survival (OS) in PD-L1 (programmed cell death protein 1)-positive patients with approval in Europe (PD-L1 CPS (combined positivity score) ≥ 5), USA and Taiwan (CHECKMATE-649) and pembrolizumab plus chemotherapy for GEJC and EC in Europe (CPS ≥ 10) and the USA (KEYNOTE-590). Furthermore, pembrolizumab plus trastuzumab and chemotherapy show clear benefits in OS and are approved as first-line treatment of Her2 (human epidermal growth factor receptor-2)-positive tumors in the USA (KEYNOTE-811). Nivolumab demonstrates superior OS regardless of PD-L1 expression in third-line therapy with approval in Japan (ATTRACTION-02) and pembrolizumab prolonged the duration of response in PD-L1 positive patients with approval in the USA in PD-L1 CPS ≥ 1 patients (KEYNOTE-059). This review reflects the rationale and current results of phase II and III clinical trials investigating various immune checkpoint inhibitors targeting PD-L1/1 and CTLA (anticytotoxic T-lymphocyte-associated antigen)-4 in combination with and without chemotherapy and Her2-targeted therapy in GC.

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Section: Palliative First-line Therapymentioning

confidence: 89%

Immunotherapy in Gastric Cancer

Högner

Möhler

2022

Current Oncology

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“…Data from the phase 3 CheckMate-649 trial ( 22 ) showed that the first-line combination therapy of nivolumab and chemotherapy showed a survival benefit in patients with advanced gastric cancer, in contrast to the chemotherapy alone. ORIENT-16 ( 23 ) demonstrated sintilimab in combination with chemotherapy significantly prolonged OS (18.4 months) in the first-line treatment of advanced gastric cancer, superior to that of nivolumab. In addition to its low price, sintilimab also had significantly lower toxicities than pembrolizumab and nivolumab.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of sintilimab combination therapy for the treatment of 48 patients with advanced malignant tumors

Huang¹,

Zhao²,

Hu³

et al. 2022

Transl Cancer Res TCR

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Background: Sintilimab is a recombinant fully human anti-programmed death 1 (PD-1) monoclonal antibody that blocks the interaction of PD-1 with its ligand. We evaluated the safety and efficacy of sintilimab combined with chemotherapy and targeted therapy in the treatment of advanced malignant tumors. Methods:We performed a retrospective analysis of the clinical data of patients with advanced malignant tumors treated with sintilimab combined with chemotherapy and targeted therapy admitted to the Third

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“…For patients with CPS ≥ 10 tumors, the median OS was 20.0 months versus 11.3 months, in favor of the sintilimab arm. Although these results are encouraging, the data regarding patients with lower CPS levels was not explicitly reported, yet the results do show the same phenomenon as seen with CHECKMATE-649, with less pronounced HRs as patients with lower PD-L1 levels were added to the analyses [ 45 ]. These results are consistent with prior studies and support the use of sintilimab in patients with CPS ≥ 10 tumors.…”

Section: The Use Of Ici In the First-line Settingmentioning

confidence: 96%

“…ORIENT-16 was a randomized, double-blind, phase 3 trial that evaluated the efficacy and safety of sintilimab plus CAPOX vs. placebo plus CAPOX for first-line treatment of advanced gastric and GEJ AC among Chinese patients [ 45 ]. In the prespecified interim analysis, 650 patients were randomized to receive sintilimab plus CAPOX ( n = 327) and placebo plus CAPOX ( n = 323).…”

Section: The Use Of Ici In the First-line Settingmentioning

confidence: 99%

Immune-Checkpoint Inhibition in the Treatment of Gastro-Esophageal Cancer: A Closer Look at the Emerging Evidence

Paydary

Reizine

Catenacci

2021

Cancers

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To date, several trials have evaluated the safety and efficacy of immune-checkpoint inhibitors (ICI) for the treatment of gastroesophageal cancers (GEC). In the US, ICIs have established indications for second-line treatment of microsatellite unstable tumors, while their use in third-line settings was recently withdrawn. Notably, the use of ICIs for first-line therapy of GEC is rapidly evolving, which currently includes high PD-L1 expressing tumors, irrespective of HER2 status, and in the adjuvant setting after neoadjuvant chemoradiotherapy in select patients. In this article, we review the results of studies that have evaluated the utility of ICI in the third-line, second-line, first-line, and peri-operative treatment settings of GECs. Considerations should be made before making any cross-trial comparisons since these trials vary in chemotherapy backbone, anatomical and histological eligibility, biomarker assessment, PD-L1 diagnostic antibodies, and definition of PD-L1 positivity. Regardless, the totality of the data suggest that first-line ICI use may most benefit GEC patients with high PD-L1 combined positivity score (CPS) ≥5 or ≥10, irrespective of histology or anatomy. Moreover, although PD-L1 by CPS has a good negative predictive value for significant benefit from ICIs, it has a low positive predictive value. Therefore, there is a pressing need to identify better biomarkers to predict benefit from ICIs among these patients.

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LBA53 Sintilimab plus chemotherapy (chemo) versus chemo as first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-16): First results of a randomized, double-blind, phase III study

Abstract: Sintilimab plus chemotherapy (chemo) versus chemo as first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-16): First results of a randomized, double-blind, phase III study

Cited by 110 publications

References 0 publications

Immunotherapy in Gastric Cancer

Immunotherapy in Gastric Cancer

Safety and efficacy of sintilimab combination therapy for the treatment of 48 patients with advanced malignant tumors

Immune-Checkpoint Inhibition in the Treatment of Gastro-Esophageal Cancer: A Closer Look at the Emerging Evidence

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