Nivolumab plus kabozantinib receives FDA approval for renal cell carcinoma (kidney cancer)

Nivolumab (Opdivo) plus kabozantinib (Cabometyx), as a combination for advanced renal cell carcinoma (kidney cancer) patients, received approval as first-line treatment on 22 January 2021 from the United States Food and Drug Administration (FDA). This became the 3rd immunotherapy plus targeted drug combination approved for kidney cancer. In addition, the nivolumab plus kabozantinib data provided the best survival data to date for advanced kidney cancer.

The CHECKMATE-9ER study

The efficacy of nivolumab plus kabozantinib in previously untreated patients with advanced kidney cancer was evaluated in a randomized, open-label clinical trial called CHECKMATE-9ER.

Patients were randomly assigned to two arms;

• The combination arm received kabozantinib 40 mg 1 time per day (323 patients) and nivolumab over 30 minutes every 2 weeks at 240 mg (323 patients).
• The control arm received oral sunitinib (Nexavar) 50 mg once daily during the first 4 weeks of each 6-week cycle (328 patients).

Results

• The study showed that, for patients treated with nivolumab plus cabozantinib compared with those receiving sunitinib, progression-free survival (PFS), overall survival and the confirmed overall response rate improved statistically significantly.
• According to blinded independent central review, progression-free survival was 8.3 months in those receiving sunitinib compared with 16.6 months in those receiving nivolumab and kabozantinib; HR 0.51 (95% CI: 0.41, 0.64).
• Median overall survival was not reached because more than half of the patients in both arms continued to survive; HR 0.60 (95% CI: 0.40, 0.89).
• The confirmed objective response rates in the nivolumab plus cabozantinib and sunitinib arms were, respectively, 55.7% and 27.1%.

Side effects

The most common (≥20%) side effects in patients receiving the nivolumab and cabozantinib combination were diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysesthesia syndrome, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia abdominal pain, cough and upper respiratory tract infection.

The recommended dose, until disease progression or unacceptable side effects, is nivolumab immunotherapy at 240 mg every 2 weeks (a 30-minute intravenous infusion) or 480 mg every 4 weeks (a 30-minute intravenous infusion), in combination with oral kabozantinib 40 mg once daily.

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