On December 28, the antibody-conjugated drug (ADC) vedotin (RC48-ADC) developed by Rongchang Biological was officially granted breakthrough therapy qualification by CDE. Indications are patients with locally advanced or metastatic urothelial carcinoma (including bladder, ureter, renal pelvis, and urethral origin) who have advanced HER2 overexpression after failure of chemotherapy. In response to this indication, the U.S. FDA has granted Vidicutumab breakthrough therapy approval on September 21.
For a long time, surgery and platinum-containing chemotherapy have been important treatments for urothelial cancer. For patients with inoperable advanced stages, the first-line therapy is usually platinum-containing chemotherapy. Resistance to chemotherapy can lead to tumor recurrence and disease progression, and the prognosis is poor. Literature data shows that the median overall survival of patients with metastatic advanced urothelial cancer is only about 14 months [1], and more effective treatments are urgently needed.
Vidicuzumab fills the huge clinical demand for HER2-positive urothelial cancer
Urothelial cancer is the ninth most common malignant tumor worldwide, and its morbidity and mortality account for male genitourinary system tumors. First place, and is on the rise year by year. Most (90%-95%) occur in the lower urinary tract (bladder and urethra), and the rest occur in the upper urinary tract (calyces, renal pelvis and ureter) [2]. Bladder cancer is the most common type of urothelial cancer. According to Datamonitor Healthcare estimates, there were more than 540,000 newly diagnosed patients worldwide in 2018, and this number is expected to increase to 600,000 cases by 2027. Bladder cancer is the fifth most common cancer in the United States and Europe, and the sixth most fatal male malignant tumor in China. In 2015, there were approximately 62,000 newly diagnosed cases in China.
Previously, vedicitumumab was approved by the US FDA as a breakthrough therapy for urothelial cancer, based on the results of a phase II study led by Professor Guo Jun, deputy dean of Peking University Cancer Hospital. Data show that 43 subjects with urothelial cancer who failed first-line and above system chemotherapy received vedicituzumab with an objective response rate (cORR) of 51.2% and a disease control rate (DCR) of 90.7%. The ORR of patients who had received immunotherapy was 62.5%. As of April 30, 2019, the median PFS was 6.9 months.
Currently, no drugs for the treatment of HER2-positive urothelial cancer have been approved at home and abroad. Vidicuzumab has achieved a major breakthrough in the efficacy of this segment of the population. It is not only efficient, but also greatly prolongs the survival period of patients who have failed first-line treatment, and can meet huge clinical needs. Vidicuzumab was awarded breakthrough therapy designation by CDE based on the clinical data it has obtained. The clinical development and registration process in China will undoubtedly be greatly accelerated, which is expected to fill the gap in the clinical treatment of HER2-positive urothelial carcinoma.
References
[1] Progress in the treatment of advanced urothelial cancer, Journal of Practical Oncology (2020), Vol.35: 292-297
[2] Progress in the surgical treatment of upper urothelial cancer, Southeast National Defense Medicine, 2020, 22 (4): 399-402
