This study was led by Professor Jin Li of Dongfang Hospital, Tongji University, with the participation of a total of 17 centers across China. Previously, four other indications of SHR-A1811 have been included in the list of breakthrough therapeutic varieties by the Drug Evaluation Center of the State Drug Administration, and the indications are: recurrent or metastatic breast cancer with low expression of HER2, HER2-positive recurrent or metastatic breast cancer, HER2-mutated advanced non-small-cell lung cancer that has failed previous platinum-containing chemotherapy, and advanced non-small-cell lung cancer that has failed previous treatments of oxaliplatin, fluorouracil, and irinotecan, and has failed previous treatments of oxaliplatin, fluorouracil, and irinotecan. irinotecan treatment failure, and HER2-positive colorectal cancer.

In 2020, gastric cancer ranks 5th in global cancer incidence and 4th in mortality. HER2-positive gastric cancer is a unique disease subtype that requires different treatment strategies from HER2-negative gastric cancer. The global HER2-positive rate of gastric cancer is 7.3%-20.2%, and the HER2-positive rate of gastric cancer in China is 12-13%.

According to the Chinese Society of Clinical Oncology (CSCO) guidelines, the objective remission rate (ORR) of standard second-line treatment for HER2-positive adenocarcinoma of the stomach or gastroesophageal junction is 13.6%-26.5%, and the median OS is 5.2-9.5 months. Currently, there is no anti-HER2 drug approved for second-line treatment of HER2-positive gastric cancer in China, and there is a huge unmet clinical need for second-line treatment of HER2-positive advanced gastric cancer.

SHR-A1811 for injection is a HER2-targeted antibody-drug coupler independently developed by Hengrui Medicine. SHR-A1811 for injection can induce apoptosis by binding to and endocytosing with HER2-expressing tumor cells, releasing toxins through proteolytic shearing in the lysosomes of the tumor cells, and inducing cell-cycle blockade. ~III clinical studies, covering advanced solid tumors with HER2 expression or mutation, advanced gastric cancer or gastroesophageal adenocarcinoma, colorectal cancer, advanced non-small cell lung cancer, metastatic breast cancer and so on.

At the Annual Meeting of the European Society for Medical Oncology (ESMO) in 2023, Hengrui Medicine disclosed data from the study of SHR-A1811 in gastric cancer or gastroesophageal conjugate adenocarcinoma, which demonstrated the good efficacy and controllable safety of SHR-A1811. In terms of efficacy, in 32 subjects with HER2-positive gastric cancer, the ORR at the RP2D dose was 43.8% and the 6-month PFS rate was 74.1%.

https://mp.weixin.qq.com/s/aYdO6gG7HedI90PEDEq5nA