On June 28, 2024, an article was published in Cancer Communications detailing a Phase I/Ib study on Disitamab Vedotin (RC48, brand name: Aidixi®) in the treatment of HER2-overexpressing and HER2-low advanced breast cancers (BCs).  Disitamab Vedotin is a novel antibody-drug conjugate (ADC) initially developed by RemeGen Co., Ltd. (“RemeGen”). Cancer Communications, sponsored by Sun Yat-sen University Cancer Center, is a top academic oncological journal with the highest impact factors in Asia. In 2023, it ranked No.1 among comprehensive oncological journals in Asia, boasting an impressive impact factor of 20.1.

2222.jpg

The published article reported the efficacy and safety of Disitamab Vedotin in the treatment of patients with HER2-overexpressing and HER2-low advanced breast cancer (ABC). All supporting data come from a study led by Professor Xu Binghe and Professor Wang Jiayu from China’s National Cancer Center/Cancer Hospital Chinese Academy of Medical Science.

The article presented a pooled analysis of the Phase I (C001) and the Phase Ib studies (C003). The C001 study enrolled 24 patients with HER2-overexpressing ABC, while C003 enrolled 46 patients with HER2-overexpressing ABC and 66 patients with HER2-low ABC. A pooled analysis revealed that, among patients who received Disitamab Vedotin at a dose of 2.0 mg/kg every two weeks, the confirmed overall response rate (cORR) and the median progression-free survival (PFS) were 42.9% and 5.7 months for those with HER2-overexpressing ABC, compared to 33.3% and 5.1 months for those with HER2-low ABC. The results demonstrated that Disitamab Vedotin had favorable efficacy and safety profiles among patients with HER2-overexpressing or HER2-low BCs.

The number of newly diagnosed cases of BC is rapidly rising globally. In 2020, 2.26 million individuals were reported diagnosed with BC for the first time globally with 416,000 in China. The outlook is particularly concerning for patients with ABC who face a 5-year survival rate of a mere 20% and a median overall survival of 2-3 years. Disitamab Vedotin is the first HER2-target ADC agent developed by a Chinese company with numerous studies performed on its monotherapies and combination therapies for BC. On June 13, 2024, RemeGen announced that a Phase Ⅲ clinical trial on Disitamab Vedotin among patients with HER2-positive ABC accompanied the liver metastasis had met its primary endpoint.