Journal
CELL REPORTS MEDICINE
Volume 3, Issue 11, Pages -Publisher
CELL PRESS
DOI: 10.1016/j.xcrm.2022.100814
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Funding
- Novocodex Biopharmaceuticals
- National Natural Science Foundation of China [82073377, 81772587, 82172861]
- Natural Science Foundation of Guangdong [2021A1515012439, 2021A1515011743]
- Science and Technology Program of Guangdong [2019B020227002]
- CAMS Innovation Fund for Medical Sciences (CIFMS) [2019-I2M-5-036]
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This clinical trial evaluates the efficacy and tolerability of ARX788 in patients with HER2-positive advanced gastric adenocarcinoma. The results demonstrate that ARX788 has promising anti-tumor activity and good tolerability in these patients.
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 15th, 2019, and March 14th, 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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