Comparing Nivolumab Plus Cabozantinib With Sunitinib for First-line Treatment of aRCC

In the phase 3 CheckMate 9ER trial, nivolumab plus cabozantinib showed improved progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in patients with previously untreated advanced renal cell carcinoma (aRCC).

A new analysis led by Maria Teresa Bourlon, MD, MSc, and presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium evaluated the efficacy and safety of nivolumab plus cabozantinib for intent-to-treat patients with aRCC.

Researchers randomly prescribed patients with either nivolumab 240 mg every 2 weeks plus cabozantinib 40 mg once per day or sunitinib 50 mg once per day for 4 weeks of 6-week cycles. Treatment continued until disease progression or unacceptable toxicity were observed. Patients could receive nivolumab for up to 2 years.

The study’s primary end point was PFS, and the secondary end points were OS, ORR, and safety.

Of the participating patients, 323 were randomized into the nivolumab-plus-cabozantinib cohort, and 328 were randomized into the sunitinib cohort.

For OS, the median follow-up time was 55.6 months. Median OS was 46.5 months for the nivolumab-plus-cabozantinib cohort and 36.0 months for the sunitinib cohort (hazard ratio [HR], 0.77; 95% CI, 0.63-0.95).

The median PFS for the nivolumab-plus-cabozantinib group was 16.4 months, and it was 8.4 months for the sunitinib group (HR, 0.58; 95% CI, 0.49-0.70). The median ORR was 55.7% for the nivolumab-plus-cabozantinib cohort and 27.7% for the sunitinib cohort.

Out of the participating patients, 97.5% experienced any-grade treatment-related adverse events (TRAEs) in the nivolumab-plus-cabozantinib group, while 93.1% in the sunitinib group reported any-grade TRAEs.

Dr. Bourlon and colleagues observed no new safety concerns.

Researchers concluded that treatment with nivolumab plus cabozantinib results in increased meaningful long-term efficacy benefits when compared with sunitinib.

“These results continue to support nivolumab plus cabozantinib as a standard of care for previously untreated aRCC,” the researchers wrote.