On November 22, RemeGen Co., Ltd.

On November 22, RemeGen Co., Ltd. (688331.SH/9995.HK) announced that the top international oncology journal, Journal of Clinical Oncology, published online the integrated analysis results of phase 2 clinical trials of Disitamab Vedotin (Trade Name: Aidixi®) for HER2-positive (IHC 3+ or 2+) locally advanced or metastatic urothelial cancer.

Journal of Clinical Oncology has been published by the American Society of Clinical Oncology since 1983, and its impact factor in 2022 is as high as 50.717. JCO is one of the oldest oncology journals highly recognized and respected by the global oncology community. It is committed to making the latest clinical research public as quickly as possible and providing doctors with high-quality theoretical support, making it a major source of information for medical professionals.

The two phase 2 open-label, multi-center, single-arm studies (RC48-C005 and RC48-C009) published this time are pooled analyses of Disitamab Vedotin in patients with HER2-overexpressing (IHC 2+ or 3+) locally advanced or metastatic urothelial carcinoma. Based on these two studies, the urothelial cancer indication of Disitamab Vedotin was approved for marketing in China by NMPA on December 31, 2021.

A total of 107 patients who had received systemic chemotherapy at least once were included in the 2 studies. Study results showed an objective response rate of 50.5% (95% CI, 40.6-60.3) as assessed by the Blinded Independent Review Committee. Consistent results were also observed in patients with liver metastases and those previously treated with PD-1/L1. As of May 10, 2022, the median duration of response (DOR) was 7.3 months, and the median progression-free survival was 5.9 months (95% CI, 4.3-7.2), and the overall survival was 14.2 months (95% CI, 9.7-18.8), and patients’ safety and tolerability were favorable.

Dr. Fang Jianmin, CEO of RemeGen says: “Disitamab Vedotin is one of the first HER2-targeted medicines in the world with significant clinical value for metastatic or locally advanced urothelial cancer. These two studies published in JCO also accelerated the approval of the medicine in China. Meanwhile, a large-scale global study initiated by our partner, Seagen, is also underway, and we look forward to the early benefit of Disitamab Vedotin to patients around the world.”

Professor Guo Jun from Peking University Cancer Hospital, the principal clinical investigator of Disitamab Vedotin says: “We are deeply committed to providing effective and safe treatment options to extend and improve the quality of life of patients with HER2-positive locally advanced or metastatic urothelial cancer. In these studies, we are pleased to find that Disitamab Vedotin has outstanding efficacy and safety in patients with refractory advanced urothelial cancer that has progressed on after chemotherapy.”