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Gastric cancer (GC) or gastroesophageal junction cancer (GEJA) is the fifth most common cancer and the fourth leading cause of cancer death in the world.
Especially in China, the incidence rate is 29.
3/100,000 and the mortality rate is 21.
2/100,000
.
In about 20% of GC patients, human epidermal growth factor receptor 2 (HER2) is overexpressed ( immunohistochemical [IHC] score of 3+ or IHC 2+, fluorescence in situ hybridization [FISH] positive)
Gastric cancer (GC) or gastroesophageal junction cancer (GEJA) is the fifth most common cancer and the fourth leading cause of cancer death in the world.
RC48 is a new recombinant human anti-her2 monoclonal antibody, conjugated to a microtubule inhibitor (monomethyl auristatin E) through a cleavable linker
The study is a single-arm, open-label Phase II trial conducted in 31 academic hospitals or cancer centers in China
.
Eligible patients are at least 18 years old and have a life expectancy of more than 12 weeks; they have received at least 2 lines of treatment or above; histologically confirmed, locally advanced or metastatic GC or GEJA; ECOG is 0-1; according to the evaluation criteria of solid tumor response (RECIST version 1.
The study is a single-arm, open-label Phase II trial conducted in 31 academic hospitals or cancer centers in China
Between July 10, 2018 and December 6, 2019, 179 patients were evaluated, 125 of whom provided reliable evidence for this study and received at least one dose of RC48
All 125 patients received RC48 monotherapy at a dose of 2.
Efficacy evaluation
Efficacy evaluationCalculate PFS and TTP on the basis of IRC evaluation
.
As of November 20, 2020, 107 patients (85.
Calculate PFS and TTP on the basis of IRC evaluation
PFS and OS
PFS and OSThe subgroup analysis was performed based on age, ECOG functional status, primary site, tumor nodules, number of metastatic sites, HER2 status, previous trastuzumab treatment, previous taxane treatment, and previous treatment lines
.
Patients over 65 years of age had significantly longer PFS than younger patients (P = 0.
The subgroup analysis was performed based on age, ECOG functional status, primary site, tumor nodules, number of metastatic sites, HER2 status, previous trastuzumab treatment, previous taxane treatment, and previous treatment lines
All patients reported at least one AE
Adverse events
Adverse eventsIn summary, studies have shown that for patients with HER2 overexpression advanced gastric cancer or gastroesophageal junction cancer who have received 2 lines or more of chemotherapy in the past, RC48 shows considerable curative effect and controllable toxicity
.
.
Studies have shown that for patients with HER2 overexpression advanced gastric cancer or gastroesophageal junction cancer who have received 2 lines or more of chemotherapy in the past, RC48 shows considerable curative effect and controllable toxicity
.
Studies have shown that for patients with HER2 overexpression advanced gastric cancer or gastroesophageal junction cancer who have received 2 lines or more of chemotherapy in the past, RC48 shows considerable curative effect and controllable toxicity
.
Original source:
Original source:Peng Z, Liu T, Wei J, Wang A, He Y, Yang L, Zhang X, Fan N, Luo S, Li Z, Gu K, Lu J, Xu J, Fan Q, Xu R, Zhang L, Li E , Sun Y, Yu G, Bai C, Liu Y, Zeng J, Ying J, Liang X, Xu N, Gao C, Shu Y, Ma D, Dai G, Li S, Deng T, Cui Y, Fang J, Ba Y, Shen L.
Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single-arm phase II study.
Cancer Commun (Lond).
2021 Oct 19.
doi: 10.
1002/cac2.
12214.
Epub ahead of print.
PMID: 34665942.
Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single-arm phase II study.
Cancer Commun (Lond).
2021 Oct 19.
doi: 10.
1002/cac2.
12214.
Epub ahead of print.
PMID: 34665942.
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