Toripalimab, axitinib combination shows promise in advanced clear cell renal cell carcinoma

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The combination of toripalimab and axitinib is a highly effective first-line treatment option for patients with previously untreated, intermediate- to poor-risk advanced clear cell renal cell carcinoma (RCC), according to data from the Phase 3 RENOTORCH study.

This combination therapy significantly prolonged progression-free survival (PFS) and demonstrated a higher overall response rate (ORR) compared to the standard treatment with sunitinib.

The study, which included 421 patients with unresectable or metastatic RCC, randomized participants to receive either toripalimab (240 mg intravenously every 3 weeks) plus axitinib (5 mg orally twice daily), or sunitinib (50 mg orally once daily for 4 weeks in a 6-week cycle, or 2 weeks in a 3-week cycle).

After a median follow-up of 14.6 months, the toripalimab-axitinib combination demonstrated a 35% reduction in the risk of disease progression or death compared to sunitinib. The PFS was notably extended, with the toripalimab-axitinib group achieving a median PFS of 18.0 months, as opposed to 9.8 months in the sunitinib group.

Overall response rate was significantly higher in the toripalimab-axitinib group, showing a 56.7% response rate compared to 30.8% in the sunitinib group.

The study also indicated a trend towards improved overall survival in the toripalimab-axitinib group, with a hazard ratio (HR) of 0.61, suggesting a 39% reduction in the risk of death compared to the sunitinib group.

Treatment-related grade ≥3 adverse events were reported in 61.5% of patients receiving toripalimab-axitinib, and 58.6% of patients in the sunitinib group, reinforcing the tolerability of both therapies.

Yan XQ, Ye MJ, Zou Q, et al. Toripalimab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma: RENOTORCH, a randomized, open-label, phase III study. Ann Oncol. 2023;S0923-7534(23)04003-6. doi: 10.1016/j.annonc.2023.09.3108. Epub ahead of print. PMID: 37872020.