Toripalimab + axitinib combination approved in China for frontline renal cell carcinoma
The National Medical Products Administration of China has approved toripalimab combined with axitinib (Inlyta) for use in the first-line treatment of patients with medium- to high-risk unresectable or metastatic renal cell carcinoma (RCC)
The regulatory decision was supported by data from the phase III RENOTORCH study (NCT04394975) in which the doublet (n = 210) significantly improved blinded independent central review (BICR)–assessed progression-free survival (PFS) vs sunitinib (Sutent) monotherapy (n = 211), at a median of 18.0 months (95% CI, 15.0-not evaluable [NE]) and 9.8 months (95% CI, 8.3-13.8), respectively (stratified, HR; 0.65; 95% CI, 0.49-0.86; P = .0028). The 12-month PFS rates with the doublet and the monotherapy were 62.7% and 45.4%, respectively; at 24 months, these rates were 44.6% and 30.2%, respectively.
“From a global perspective, targeted therapy in combination with immunotherapy has become the standard treatment approach for advanced RCC,” Professor Jun Guo, MD, PhD, from Peking University Cancer Hospital, stated in a press release. “However, no such treatments have been approved in China. The approval of toripalimab’s new indications opens a new chapter in combined targeted therapy and immunotherapy in China, and it will transform current clinical practices for advanced RCC and introduce new treatment options for medium to high-risk patients.”
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