RENOTORCH: Examining Toripalimab Plus Axitinib for Previously Untreated aRCC

Toripalimab is a known monoclonal antibody against PD-1; anti-PD-1 antibodies plus antiangiogenic therapy can play a synergistic antitumor role in the treatment of advanced renal cell cancer (aRCC). The randomized, open-label, phase 3 RENOTORCH trial compared toripalimab plus axitinib with sunitinib as a first-line treatment for aRCC. Results were presented by Dr. Xinan Sheng at the European Society for Medical Oncology Congress 2023.

The trial enrolled patients with untreated unresectable or metastatic clear cell RCC (mccRCC) who were ranked as intermediate or poor risk per the International Metastatic Renal Cell Carcinoma Database Consortium criteria. The primary end point was progression-free survival (PFS).

A total of 421 patients were enrolled and randomized 1:1 to receive toripalimab 240 mg intravenously once every 3 weeks plus axitinib 5 mg orally twice daily, or sunitinib 50 mg orally once daily for 4 weeks (6-week cycle) or 2 weeks (3-week cycle). The toripalimab-plus-axitinib arm included 210 patients, and the sunitinib arm included 211 patients. After a median follow-up of 14.6 months, the toripalimab-plus-axitinib arm showed a significant improvement in median PFS compared with the sunitinib arm (18.0 vs 9.8 months; hazard ratio [HR], 0.66; 95% CI, 0.49-0.87; P=.0034).

The 1-year PFS rates in the toripalimab-plus-axitinib arm and sunitinib arm were 62.5% and 45.4%, respectively. The objective response rate (ORR) was 56.7% (95% CI, 49.7-63.5) in the toripalimab-plus-axitinib arm versus 30.8% (95% CI, 24.6-37.5) in the sunitinib arm (P<.0001). The median overall survival was not reached in the toripalimab-plus-axitinib arm and was reached at 26.8 months in the sunitinib arm (HR, 0.61; 95% CI, 0.40-0.92; P=.0186). The incidence of grade ≥3 adverse events (AEs; 71.2% vs 67.1%), AEs leading to discontinuation of treatment (14.4% vs 8.1%), and fatal AEs (1.0% vs 1.0%) were similar in both treatment arms.

In patients with previously untreated advanced RCC, toripalimab plus axitinib resulted in significantly longer PFS and a higher ORR than sunitinib, supporting the use of toripalimab plus axitinib as a first-line treatment for aRCC.