(Kidney Cancer) Opdivo + Cabometyx Combination Therapy Approved in Japan

On August 25, 2021, Ono Pharmaceutical and Takeda Pharmaceutical announced that Opdivo (nivolumab) plus Cabometyx (cabozantinib) combination therapy received approval for treating patients with unresectable or metastatic renal cell carcinoma.

Kidney cancer affects approximately 25,000 new patients per year in Japan, with approximately 8,550 deaths annually. Renal cell carcinoma accounts for 90% of these cases.

This approval was based on the CheckMate-9ER Phase III clinical trial results. The trial assigned patients in a 1:1 ratio to either the Opdivo combination therapy group (every 2 weeks: Opdivo 240mg + once-daily Cabometyx 40mg) or the Sunitinib group (every 6 weeks: Sunitinib 50mg once daily for 4 weeks followed by 2 weeks rest). The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS) and objective response rate (ORR). Analysis results showed significant improvement in progression-free survival, overall survival, and objective response rate. The safety profile of the Opdivo plus Cabometyx combination therapy was consistent with previously reported adverse event data.

Source: https://www.ono.co.jp/news/20210825.html

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