scholarly journals Study on Efficacy and Safety of Low-Dose Apatinib Combined with Camrelizumab and SOX Regimen as First-Line Treatment of Locally Advanced and Unresectable Gastric/Gastroesophageal Junction Cancer: A Protocol for an Open-Label, Dose Escalation and Extension Phase Ib Clinical Trial

2021 ◽  
Vol Volume 14 ◽  
pp. 4859-4865
Author(s):  
Kang-Xin Wang ◽  
Ting-Yun Cui ◽  
Xu-Dong Yang ◽  
Guo-Qun Wang ◽  
Qiu-Sheng Jiang ◽  
...  
Keyword(s):  
Low Dose ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Efficacy And Safety ◽  
First Line ◽  
Open Label ◽  
Phase Ib ◽  
Gastroesophageal Junction Cancer ◽  
Label Dose ◽  
First Line Treatment

Efficacy and safety of toripalimab combination with SOX regimen as a first-line treatment in patients with unresectable locally advanced or recurrent/metastatic gastric/gastroesophageal junction cancer: Preliminary data from a single-armed, exploratory study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16015-e16015
Author(s):  
Xiaolin Lin ◽  
Qing Xia ◽  
Ting Han ◽  
Meng Zhuo ◽  
Haiyan Yang ◽  
...  
Keyword(s):  
Disease Control ◽  
Gastroesophageal Junction ◽  
Objective Response ◽  
Locally Advanced ◽  
Disease Control Rate ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Gastroesophageal Junction Cancer ◽  
First Line Treatment

e16015 Background: Gastric cancer (GC) is one of the most common malignancies of the digestive system with a poor prognosis and limited treatment option. Currently immunotherapy is approved for the third-line treatment of GC, but there are limited data on first-line treatment. Therefore, this study will further explore the efficacy and safety of the domestic PD-1 antibody toripalimab combined with S-1 plus oxaliplatin (SOX) regimen as the first-line treatment of unresectable locally advanced or recurrent/metastatic gastric/gastroesophageal junction cancer. Methods: A prospective, single-armed, exploratory, investigated initiated trial explores the efficacy and safety of toripalimab combined with SOX regimen as first-line treatment of unresectable locally advanced or recurrent/metastatic gastric/gastroesophageal junction cancer. The primary objectives are objective response rate (ORR). Secondary objectives include disease control rate (DCR), DOR, PFS, and OS. The dosage regimen is: Toripalimab, 240mg D1; oxaliplatin, 130mg/m2, D1 ; S-1, 40mg/m2, bid oral D1-14 days, every 21 days as a cycle and plan 6 cycles of treatment. Tumor responses were assessed radiologically every two cycles. Major eligibility requirements include: unresectable advanced, recurrent or metastatic gastric/gastroesophageal junction cancer with diagnoses confirmed histologically or cytologically, age 18 and 80 years, first-line treatment, at least one measurable lesion according to RECIST 1.1, ECOG 0-1, adequate organ function and HER-2 negative. Results: So far, 17 of planned 20 patients have been enrolled. 14 patients completed 2 cycles of treatment, the ORR rate was 57% (8/14) and the disease control rate (DCR) was 93% (13/14). 10 patients completed 4 cycles of treatment, the ORR rate was 60% (6/10) and the disease control rate (DCR) was 90% (9/10). 7 patients completed 6 cycles of treatment, the ORR rate was 43% (3/7) and the disease control rate (DCR) was 57% (4/7). Common adverse reactions during treatment in 17 patients included rash 17.6% (3/17), diarrhea 41.2% (7/17), hypothyroidism 11.8% (2/17), elevated amylase 35.3% (6/17), decreased platelets 41.2% (7/17), mostly grade I-II. Conclusions: Toripalimab combination with SOX regimen as a first-line treatment demonstrated promising anti-tumor activity in unresectable locally advanced or recurrent/metastatic gastric/gastroesophageal junction cancer patients with a good ORR and controllable safety. Clinical trial information: NCT04202484.

CA224-060: A randomized, open label, phase II trial of relatlimab (anti-LAG-3) and nivolumab with chemotherapy versus nivolumab with chemotherapy as first-line treatment in patients with gastric or gastroesophageal junction adenocarcinoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS4143-TPS4143 ◽  
Author(s):  
Kynan Feeney ◽  
Ronan Kelly ◽  
Lara Rachel Lipton ◽  
Joseph Chao ◽  
Mirelis Acosta-Rivera ◽  
...  
Keyword(s):  
T Cell ◽  
Immune Checkpoint ◽  
Gastroesophageal Junction ◽  
Objective Response ◽  
Locally Advanced ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Multiple Tumor ◽  
First Line Treatment

TPS4143 Background: Blockade of the immune checkpoint receptor programmed death-1 (PD-1) has shown clinical benefit in multiple tumor types. Nivolumab (anti–PD-1) has demonstrated a survival advantage versus (vs) placebo in patients (pts) with advanced gastric cancer (GC) or gastroesophageal junction cancer (GEJC) (Kang YK et al. Lancet 2017;390:2461–71). Lymphocyte activation gene 3 (LAG-3) is an immune checkpoint molecule that negatively regulates effector T-cell function and is a marker of T-cell exhaustion. Preliminary data in melanoma suggest that combining nivolumab with relatlimab (anti–LAG-3) could improve efficacy without substantially increasing toxicity vs nivolumab especially, but not exclusively, in LAG-3-expressing pts (Ascierto PA et al. Ann Oncol 2017;28(S5):LBA18). Furthermore, LAG-3 expression was as high as 33% in an analysis of solid tumors including GC (Edwards R et al. J Immunother Cancer 2017;5(S3):P510). Study CA224-060 will assess the clinical efficacy and safety of relatlimab and nivolumab with chemotherapy for first-line treatment of GC or GEJC. Methods: This is a randomized, open-label, multicenter, phase 2 study of relatlimab and nivolumab with oxaliplatin-based chemotherapy vs nivolumab with oxaliplatin-based chemotherapy. Approximately 250 adult pts with untreated, locally advanced, unresectable or metastatic GC or GEJC will be enrolled. To be randomized, pts must have tumor tissue for analysis of biomarkers, LAG-3 status, and PD-L1 combined positive score. Key exclusion criteria include HER2-positive status, untreated CNS metastases, or significant cardiovascular disease. The primary endpoint is objective response rate (ORR) using RECIST v.1.1 by blinded independent central review in LAG-3-expressing pts. Other endpoints include investigator-assessed ORR, ORR in LAG-3-negative pts, duration of response, overall survival, progression-free survival, and safety and tolerability. Efficacy signals in biomarker subgroups will be explored. Currently, 26 sites are activated with 15 randomized pts. Clinical trial information: NCT03662659.

scholarly journals Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100

2020 ◽  
pp. JCO.20.00892
Author(s):  
Markus Moehler ◽  
Mikhail Dvorkin ◽  
Narikazu Boku ◽  
Mustafa Özgüroğlu ◽  
Min-Hee Ryu ◽  
...  
Keyword(s):  
Induction Chemotherapy ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Growth Factor Receptor ◽  
Phase Iii ◽  
First Line ◽  
Open Label ◽  
Phase Iii Trial ◽  
Gastroesophageal Junction Cancer ◽  
Positive Population

PURPOSE The role of maintenance therapy for gastric (GC) or gastroesophageal junction cancer (GEJC) is unclear. We investigated avelumab (anti–programmed death ligand-1 [PD-L1]) maintenance after first-line induction chemotherapy for GC/GEJC. PATIENTS AND METHODS JAVELIN Gastric 100 was a global, open-label, phase III trial. Eligible patients had untreated, unresectable, human epidermal growth factor receptor 2–negative, locally advanced or metastatic GC or GEJC. Patients without progressive disease after 12 weeks of first-line chemotherapy with oxaliplatin plus a fluoropyrimidine were randomly assigned 1:1 to avelumab 10 mg/kg every 2 weeks or continued chemotherapy, stratified by region (Asia v non-Asia). The primary end point was overall survival (OS) after induction chemotherapy in all randomly assigned patients or the PD-L1–positive randomly assigned population (≥ 1% of tumor cells; 73-10 assay). RESULTS A total of 805 patients received induction; 499 were randomly assigned to avelumab (n = 249) or continued chemotherapy (n = 250). Median OS was 10.4 months (95% CI, 9.1 to 12.0 months) versus 10.9 months (95% CI, 9.6 to 12.4 months) and 24-month OS rate was 22.1% versus 15.5% with avelumab versus chemotherapy, respectively (hazard ratio [HR], 0.91; 95% CI, 0.74 to 1.11; P = .1779). In the PD-L1–positive population (n = 54), the HR for OS was 1.13 (95% CI, 0.57 to 2.23; P = .6352). In an exploratory analysis of the PD-L1–positive population, defined as combined positive score ≥ 1 (22C3 assay; n = 137), median OS was 14.9 months (95% CI, 8.7 to 17.3 months) with avelumab versus 11.6 months (95% CI, 8.4 to 12.6 months) with chemotherapy (unstratified HR, 0.72; 95% CI, 0.49 to 1.05). With avelumab and chemotherapy, treatment-related adverse events (TRAEs) occurred in 149 (61.3%) and 184 (77.3%) patients, including grade ≥ 3 TRAEs in 31 (12.8%) and 78 (32.8%) patients, respectively. CONCLUSION JAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1–positive population.

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