Reference Detail

Ref Type

Journal Article

PMID

(33457083)

Authors

Xu J, Xu N, Bai Y, Liu R, Mao C, Sui H, Wang X, Jiang Q, Dou Y

Title

Anti-PD-1 antibody HX008 combined with oxaliplatin plus capecitabine for advanced gastric or esophagogastric junction cancer: a multicenter, single-arm, open-label, phase Ib trial.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Oncoimmunology	10	1	2020 12 31	1864908	Oncoimmunology

URL

Abstract Text

Anti-PD-1 monoclonal antibody is approved as an option for third-line treatment of advanced gastric and gastroesophageal junction (G/GEJ) cancer in several countries, but no anti-PD-1 monoclonal antibody treatment is yet approved for first-line treatment of advanced G/GEJ cancer. We report a phase Ib trial of HX008, a highly selective, humanized anti-programmed death-1 monoclonal antibody, plus oxaliplatin and capecitabine as first-line treatment for advanced G/GEJ cancer. Patients with previously untreated, locally advanced or metastatic G/GEJ cancer were enrolled. All patients received HX008 3 mg/kg intravenously every 3 weeks, oxaliplatin 130 mg/m2 intravenously on day 1 every 3 weeks (up to 6 cycles), and capecitabine 1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break. The primary end point was the incidence of adverse events and serious adverse events. In total, 35 patients were enrolled. Median follow-up was 12.7 months. Most frequent (>10%) grade ≥3 treatment-related adverse events were anemia (27.5%), neutropenia (20%), thrombocytopenia (17.1%), leukopenia (17.1%) and fatigue (17.3%). Objective response rate was 60.0% (95% confidence interval [CI] 42.1-76.1%). Disease control rate was 77.1% (95% CI 59.9-89.6). Median time to response and duration of response were 1.4 months (range 1.3-2.9) and 12.3 months (range 1.4-17.9+), respectively. Median PFS was 9.2 months (95% CI 5.4-not reached). These results demonstrated that HX008 combined with oxaliplatin plus capecitabine was well tolerated and demonstrated encouraging efficacy as first-line treatment for advanced G/GEJ cancer. This study was registered in china, register number was CTR20181270.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 positive	gastroesophageal junction adenocarcinoma	not predictive	Capecitabine + HX008 + Oxaliplatin	Phase I	Actionable	In a Phase Ib trial, treatment with HX008, Xeloda (capecitabine), and Eloxatin (oxaliplatin) combination therapy resulted in an objective response rate (ORR) of 75% (9/12) and disease control rate (DCR) of 83.3% (10/12) in CD274 (PD-L1)-positive gastric or gastroesophageal junction cancer patients, compared to an ORR and DCR of 66.7% (6/9) and 100% (9/9) respectively in CD274 (PD-L1)-negative patients; however, no difference was observed in progression-free survival (p=0.19) (PMID: 33457083).	33457083
CD274 positive	stomach cancer	not predictive	Capecitabine + HX008 + Oxaliplatin	Phase I	Actionable	In a Phase Ib trial, treatment with HX008, Xeloda (capecitabine), and Eloxatin (oxaliplatin) combination therapy resulted in an objective response rate (ORR) of 75% (9/12) and disease control rate (DCR) of 83.3% (10/12) in CD274 (PD-L1)-positive gastric or gastroesophageal junction cancer patients, compared to an ORR and DCR of 66.7% (6/9) and 100% (9/9) respectively in CD274 (PD-L1)-negative patients; however, no difference was observed in progression-free survival (p=0.19) (PMID: 33457083).	33457083