Exelixis recently announced that its Japanese partner Takeda Pharmaceuticals has obtained approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to produce and sell the targeted anticancer drug Cabometyx (cabozantinib) for unresectable and metastatic renal cell carcinoma RCC) treatment of patients. According to the cooperation and licensing agreement signed by both parties, Exelixis is eligible to receive a milestone payment of US $ 31 million when the first commercial sale of Cabometyx for unresectable or metastatic RCC is performed in Takeda.
This approval is based on data from 3 clinical studies: (1) The METEOR study, a key phase III study sponsored by Exelixis, receiving treatment with at least one VEGF receptor tyrosine kinase inhibitor (VEGFR-TKI) In advanced RCC patients with advanced disease, the efficacy and safety of Cabometyx relative to everolimus were evaluated; (2) CABOSUN study, which is a phase II study sponsored by the Cancer Clinical Trials Alliance (ACTO), It was conducted in middle- and high-risk patients with advanced RCC who had not received previous treatment, and compared the efficacy and safety of Cabometyx compared to sunitinib (Sunitinib); The study was conducted in 35 Japanese patients with advanced RCC who had progressed after VEGFR-TKI treatment.
Kidney cancer is one of the most common types of cancer in men and women. Clear cell RCC is the most common type of kidney cancer in adults. If found early, the 5-year survival rate of RCC is high. For patients with advanced or advanced metastatic RCC, the 5-year survival rate is only 12%.
Most clear cell RCC tumors have lower than normal levels of von Hippel-Lindau (VHL) protein, which results in higher levels of MET, AXL, and VEGF. These proteins can promote tumor angiogenesis, growth, invasion and metastasis. MET and AXL may provide escape routes that drive resistance to VEGF receptor inhibitors.
Cabometyx's active pharmaceutical ingredient is cabozantinib, which exerts an anti-tumor effect through targeted inhibition of MET, VEGFR2 and RET signaling pathways, killing tumor cells, reducing metastasis and inhibiting angiogenesis. In the United States and the European Union, Cabometyx is approved for the treatment of patients with advanced RCC and patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib.
Exelixis granted Takeda exclusive rights in 2017 regarding the commercialization and further clinical development of Cabometyx for all indications in the Japanese market in the future. In January 2020, Takeda submitted an application for Cabometyx in Japan to treat hepatocellular carcinoma (HCC) who had previously received sorafenib, triggering a milestone payment of $ 10 million.