Phase 1 multicenter, dose-expansion study of ARX788 as monotherapy in HER2-positive advanced gastric and gastroesophageal junction adenocarcinoma.

Cell Rep Med

Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou 510060, P.R. China; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou 510060, P.R. China. Electronic address:

Published: November 2022

AI Article Synopsis

  • ARX788 is an experimental drug designed for treating advanced gastric cancer that expresses HER2, utilizing a targeted approach by combining an antibody with a toxic drug (AS269).
  • In a clinical trial involving 30 patients who didn’t respond to standard treatment, over 93% experienced side effects, but the drug showed a 37.9% success rate in reducing tumors.
  • The study found median progression-free survival of 4.1 months and overall survival of 10.7 months, indicating that ARX788 is not only tolerable but also has potential benefits for patients with this type of cancer.

Article Abstract

ARX788 is an anti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugate with AS269 as cytotoxic payload. In this phase 1 multicenter dose-expansion clinical trial, patients with HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma failing to respond to prior trastuzumab-based standard treatment were enrolled. Between July 15, 2019, and March 14, 2022, 30 participants were enrolled. Twenty-eight (93.3%) patients experienced at least one drug-related adverse event (AE) and 13.3% experienced grade 3 ARX788-related AEs. The confirmed objective response rate is 37.9% (95% confidence interval [CI]: 20.7%-57.7%) and the disease control rate is 55.2% (95% CI: 35.7%-73.6%). With a median follow up of 10 months, the median progression-free survival and overall survival are 4.1 (95% CI: 1.4-6.4) and 10.7 months (95% CI: 4.8-not reached), respectively. The median duration of response is 8.4 (95% CI: 2.1-18.9) months. ARX788 is well tolerated and has promising anti-tumor activity in patients with HER2-positive advanced gastric adenocarcinoma (ChinaDrugTrials.org.cn: CTR20190639).

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9729820PMC
http://dx.doi.org/10.1016/j.xcrm.2022.100814DOI Listing

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