The 57th annual meeting of the American Society of Clinical Oncology (ASCO) was opened on June 4, 2021 (Eastern Time). RemeGen released the latest data of a number of clinical studies on Disitamab Vedotin, an ADC drug independently researched and developed in China, by Poster Discussion and Poster. The new breakthrough made by RC48 in urothelial carcinoma and breast cancer is exciting.
ASCO annual meeting brings the world's top oncology experts, well-known pharmaceutical companies, research institutions and investment institutions together and it is recognized as the largest, highest academic level and most authoritative academic event in the field of oncology in the world. Before then, Disitamab Vedotin developed by RemeGen has been presented at ASCO for three consecutive years, and its clinical research results for urothelial carcinoma, gastric cancer, breast cancer and other indications continue to bring surprises to patients.
In 2021 ASCO annual meeting, RemeGen released clinical research conclusion by Beijing Cancer Hospital Professor Guo Jun about over expression of HER2 local advancement or the single arm multicenter phaseⅡ clinical research of urothelial carcinoma. This study showed that Disitamab Vedotin has prominent curative effect and survival benefit for patients who has received second-line or above systemic chemotherapy. (Poster#4584)
Besides, RemeGen released the results of Phase Ib/Ⅱ study in combination with PD-1 antibody Toripalimab in locally advancement or metastatic urothelial carcinoma of Disitamab Vedotin, this research is led by Beijing Cancer Hospital Professor Guo Jun and conducted by Professor Sheng Xinan.
The research showed that Disitamab Vedotin combined PD-1 monoclonal antibody has prominent curative effect on first-line metastatic urothelial carcinoma.
In 16 patients with varying levels of HER2 expression, the objective response rate(ORR) reached 100%! This outstanding efficacy not only successfully validates the treatment concept of ADC combined with immune checkpoint inhibitors, but also expected to be a major breakthrough in the treatment of first-line urothelial carcinoma. This study deserves continued attention for its long-term PFS and OS survival benefits. (Poster#4534)
Prior to the release of the results of the two clinical studies, breakthrough therapy designation was granted to Disitamab Vedotin by both FDA and NMPA in Urothelial Carcinoma based on its world’s leading clinical data, it was the first time for a China ADC drug.
In addition to its breakthroughs in Urothelial Carcinoma, Disitamab Vedotin has also shown encouraging data in breast cancer.
In ASCO 2021, the pooled analysis of Phase Ⅰ and Phase 1B study of Disitamab Vedotin in the treatment of HER2-positive and HER2-low expressed breast cancer which is led by Cancer Hospital Chinese Academy of Medical Sciences Professor Xu Binghe and Professor Wang Jiayu was released. This is the second time that Disitamab Vedotin been included in the Poster Discussion of ASCO following the urothelial carcinoma study in 2019. The strong strength of Disitamab Vedotin in the HER2 field has attracted continuous attention from the academic community.
This analysis showed that Disitamab Vedotin had a favorable response in patients with low expression of HER2. Notably, in patients with very low HER2 expression (IHC 1+), Disitamab Vedotin still showed a good response rate and progression-free survival benefit, which brings new hope for meeting the clinical needs of patients with low HER2 expression. (Poster#1022)