1445P CS1001, an anti-PD-L1 antibody, combined with standard of care (SOC) chemotherapy for first line (1L) advanced GC/GEJ and ESCC: Preliminary results from 2 phase Ib cohorts of CS1001-101 study

Shen, Lin; Li, J.; Miao, Zhanhui; Xu, Nong; Liu, B.; Li, X.; Zhang, Q.; Gao, Quanli; Zhao, Yanqiu; Pan, Hongming; Pei, Zhijun; Li, W.; Xia, Haoran; Wang, J.; Dai, Hangjun; Shi, Qianling; Yang, Jingwen

doi:10.1016/j.annonc.2020.08.1951

Cited by 9 publications

(8 citation statements)

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“…The treatment-emergent adverse events reported in this study were consistent with the safety profile of sugemalimab 13 , 14 , 16 , 17 and other immune checkpoint inhibitors in similar patients. 18 - 20 Treatment-related adverse events were manageable as most of them were grade 1-2 in severity.…”

Section: Discussionsupporting

confidence: 81%

“…Our safety findings were consistent with the expected safety profile of this drug class and with previous reports of sugemalimab in advanced non-smallcell lung cancer and other solid tumors. 13,14,16,17 In this study, the majority of responding patients achieved complete response, and although cross-trial comparison is difficult and should be interpreted with caution, this was numerically higher than the reported data from other PD-1/PD-L1 inhibitors. [18][19][20] Moreover, achieving complete response, instead of partial response, has been closely correlated with longer survival in ENKTL.…”

Section: Discussioncontrasting

confidence: 65%

“…Our safety findings were consistent with the expected safety profile of this drug class and with previous reports of sugemalimab in advanced non–small-cell lung cancer and other solid tumors. 13 , 14 , 16 , 17 …”

Section: Discussionmentioning

confidence: 99%

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Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study

Huang

Tao

Hao

et al. 2023

JCO

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PURPOSE Relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) is a rare and aggressive type of non-Hodgkin lymphoma with limited treatment options. This phase II study evaluated the efficacy and safety of sugemalimab, an anti–PD-L1 monoclonal antibody, in R/R ENKTL. METHODS Eligible patients received sugemalimab 1,200 mg intravenously once every 3 weeks for up to 24 months or until progression, death, or study withdrawal. The primary end point was objective response rate (ORR) assessed by an independent radiologic review committee. Key secondary end points included ORR assessed by the investigators, complete response rate, duration of response, and safety. RESULTS At the data cutoff (February 23, 2022), 80 patients were enrolled and followed for a median of 18.7 months. At baseline, 54 (67.5%) had stage IV disease and 39 (48.8%) had received ≥2 lines of prior systemic therapy. Independent radiologic review committee–assessed ORR was 44.9% (95% CI, 33.6 to 56.6); 28 (35.9%) patients achieved a complete response and seven (9.0%) achieved a partial response, with a 12-month duration of response rate of 82.5% (95% CI, 62.0 to 92.6). Investigator-assessed ORR was 45.6% (95% CI, 34.3 to 57.2), and 24 (30.4%) patients achieved a complete response. Most treatment-emergent adverse events were grade 1-2 in severity, and grade ≥ 3 events were reported in 32 (40.0%) patients. CONCLUSION Sugemalimab showed robust and durable antitumor activity in R/R ENKTL. Treatment was well tolerated with expected safety profile for this drug class.

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Section: Discussionsupporting

confidence: 81%

Section: Discussioncontrasting

confidence: 65%

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Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study

Huang

Tao

Hao

et al. 2023

JCO

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“…Immune checkpoint inhibitors that target programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) have shown promising survival benefits and manageable safety in first-line treatment of patients with G/GEJ cancers in the CheckMate-649 10 , GEMSTONE-101 11 , and ORIENT-16 trials 12 . By binding to PD-1, activating antigen-specific T cells, and reversing the immune evasion of cancer, immunotherapy may be more effective in the early stages of G/GEJ cancers when the tumor is still present after the approach known as neoadjuvant therapy 13 .…”

Section: Introductionmentioning

confidence: 99%

Neoadjuvant sintilimab in combination with concurrent chemoradiotherapy for locally advanced gastric or gastroesophageal junction adenocarcinoma: a single-arm phase 2 trial

Wei,

Lu,

Liu

et al. 2023

Nat Commun

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In this multicenter, single-arm phase 2 trial (ChiCTR1900024428), patients with locally advanced gastric/gastroesophageal junction cancers receive one cycle of sintilimab (anti-PD1) and chemotherapy (S-1 and nab-paclitaxel), followed by 5 weeks of concurrent chemoradiotherapy and sintilimab, and another cycle of sintilimab and chemotherapy thereafter. Surgery is preferably scheduled within one to three weeks, and three cycles of adjuvant sintilimab and chemotherapy are administrated. The primary endpoint is the pathological complete response. Our results meet the pre-specified primary endpoint. Thirteen of 34 (38.2%) enrolled patients achieve pathological complete response (95% CI: 22.2-56.4). The secondary objectives include disease-free survival (DFS), major pathological response, R0 resection rate, overall survival (OS), event-free survival (EFS), and safety profile. The median DFS and EFS were 17.0 (95%CI: 11.1-20.9) and 21.1 (95%CI: 14.7-26.1) months, respectively, while the median OS was not reached, and the 1-year OS rate was 92.6% (95%CI: 50.1-99.5%). Seventeen patients (50.0%) have grade ≥3 adverse events during preoperative therapy. In prespecified exploratory biomarker analysis, CD3+ T cells, CD56+ NK cells, and the M1/M1 + M2-like macrophage infiltration at baseline are associated with pathological complete response. Here, we show the promising efficacy and manageable safety profile of sintilimab in combination with concurrent chemoradiotherapy for the perioperative treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma.

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“…In China, guidelines list nivolumab plus XELOX/FOLFOX the preferred regimen for PD-L1-positive AGC ( 9 ). Additionally, in China, many newly developed domestic ICIs are used in clinical trials for first-line treatment of AGC, such as ORIENT-16 ( 10 ), CS1001-101 ( 11 ) and SHR1210 ( 12 ). The above research results have confirmed the exact efficacy of paclitaxel plus ICIs in the therapy of AGC.…”

Section: Introductionmentioning

confidence: 99%

Immune checkpoint inhibitors combined with paclitaxel-based chemotherapy versus chemotherapy alone as first-line treatment in HER2-negative advanced gastric cancer: result of a multicenter retrospective study

Fang,

Zhao,

et al. 2024

J Gastrointest Oncol

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Background Platinum-based chemotherapy combined with immune checkpoint inhibitors (ICIs) is now becoming the standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-negative advanced gastric cancer (AGC). In China, paclitaxel has shown good efficacy and tolerability in AGC as an alternative for first-line therapy. Combining ICIs with paclitaxel-based chemotherapy may lead to improved tumor immune microenvironment, but evidence in paclitaxel combing with ICIs as first-line regimen is lacking. This multicenter, retrospective research aims to compare effectiveness and tolerability of paclitaxel-based chemotherapy combined with ICIs versus chemotherapy alone as a first-line treatment of HER2-negative AGC in a real-world setting. Methods Eighty-six patients with HER2-negative AGC were included from 2017 to 2022. Among them, 57 patients received paclitaxel-based chemotherapy plus ICIs, and 29 patients received paclitaxel-based chemotherapy alone. We compared the efficacy and incidence of adverse events between the two therapy options. Results Significant improvements in median progression-free survival (PFS) (8.77 versus 7.47 months; P=0.04) and median overall survival (OS) (15.70 versus 14.33 months; P=0.04) were observed in the ICIs combined with paclitaxel-based chemotherapy group. The use of ICIs also significantly prolonged the duration of response (DOR) (7.47 versus 4.59 months; P=0.02). Meanwhile, the ICIs plus chemotherapy group demonstrated significantly improved objective response rate (ORR) (50.9% vs. 27.6%; P=0.03) and disease control rate (DCR) (98.3% vs. 82.8%; P=0.01), and the side effects were tolerable. Conclusions In summary, for HER2-negative AGC, ICIs plus paclitaxel-based chemotherapy is effective with mild toxicities, which should be considered as an alternative first-line therapy regimen.

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1445P CS1001, an anti-PD-L1 antibody, combined with standard of care (SOC) chemotherapy for first line (1L) advanced GC/GEJ and ESCC: Preliminary results from 2 phase Ib cohorts of CS1001-101 study

Cited by 9 publications

References 0 publications

Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study

Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study

Neoadjuvant sintilimab in combination with concurrent chemoradiotherapy for locally advanced gastric or gastroesophageal junction adenocarcinoma: a single-arm phase 2 trial

Immune checkpoint inhibitors combined with paclitaxel-based chemotherapy versus chemotherapy alone as first-line treatment in HER2-negative advanced gastric cancer: result of a multicenter retrospective study

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