20 Results The CABOSUN trial enrolled 157 patients who were randomised 1:1 to receive cabozantinib (n=78) or sunitinib (n=79). Patient characteristics: • 81% of patients were intermediate risk • 19% of patients were poor risk according to IMDC criteria • 25% of patients had not had prior nephrectomy • 36% had bone metastases • 73% had two or more metastatic sites • Tumour MET status was determined for 83% of patients • 39% of all randomised patients were MET positive • 44% were MET negative • Key ndings PROGRESSION-FREE SURVIVAL (PFS): Median PFS per independent radiology review committee (IRC) was 8.6 months for cabozantinib vs. 5.3 months for sunitinib (HR 0.48, p=0.0008). Subgroup analyses showed consistent benets for cabozantinib, with MET-positive patients showing the greatest improvement. OBJECTIVE RESPONSE RATE (ORR): ORR per IRC was 20% for cabozantinib vs. 9% for sunitinib. TUMOUR REDUCTION: Tumour reduction was observed in 80% of cabozantinib patients vs. 50% of sunitinib patients. OVERALL SURVIVAL (OS): Median OS was 26.6 months for cabozantinib vs. 21.2 months for sunitinib (HR 0.80). SAFETY: Grade 3 or 4 adverse events occurred in 68% of cabozantinib patients and 65% of sunitinib patients. Common adverse events included diarrhoea, hypertension, and fatigue for cabozantinib, and fatigue, decreased platelet count, and diarrhoea for sunitinib. Conclusion In this phase 2 study, cabozantinib treatment resulted in clinically meaningful and statistically signicant prolongation of PFS per IRC when compared with sunitinib as initial targeted therapy in patients with advanced RCC. The independent assessment conrms the investigator-assessed results for PFS and supports the use of cabozantinib as initial therapy for patients with advanced RCC of intermediate or poor risk.
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