Shots:

• The approval is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC
• Results: @median follow-up of 10.6 mos.; m-PFS (16.6 vs 8.3mos.)- ORR (55.7% vs 27.1%); CR (9.3% vs 4.3%); OS (40% reduction in risk of death)- Grade 3+ AEs (75% vs 71%)- was well tolerated with a low rate of TREA leading to discontinuations (5.6 % vs 8.8%)
• Two Opdivo-based therapies (Opdivo + Yervoy & Opdivo + Cabometyx) are now authorized for 1L treatment of patients with advanced RCC in EU countries

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