Opdivo + Cabometyx receives FDA approval for advanced renal cell carcinoma

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FDA has approved a combination of Opdivo (nivolumab) and Cabometyx (cabozantinib) as first-line treatment for patients with advanced renal cell carcinoma.

Opdivo is sponsored by Bristol-Myers Squibb and Cabometyx is sponsored by Exelixis.

Efficacy was evaluated in CHECKMATE-9ER (NCT03141177), a randomized, open-label trial in patients with previously untreated advanced RCC. Patients were randomized to receive either nivolumab 240 mg over 30 minutes every two weeks in combination with cabozantinib 40 mg orally once daily (n=323) or sunitinib 50 mg orally daily for the first four weeks of a six-week cycle (four weeks on treatment followed by two weeks off) (n=328).

The trial demonstrated a statistically significant improvement in progression-free survival, overall survival, and confirmed overall response rate for patients treated with Opdivo plus Cabometyx compared with those who received sunitinib. Median PFS per blinded independent central review (BICR) was 16.6 months versus 8.3 months; HR 0.51 (95% CI: 0.41, 0.64).

Median OS was not reached in either arm; HR 0.60 (95% CI: 0.40, 0.89). Confirmed ORR per BICR was 55.7% and 27.1% in the nivolumab plus cabozantinib and sunitinib arms, respectively.

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