First-Line Nivolumab Plus Cabozantinib Yields Superior Efficacy vs Sunitinib for Renal Cell Carcinoma

Nivolumab plus cabozantinib showed improved efficacy over sunitinib for patients with previously untreated advanced renal cell carcinoma, according to the extended follow-up analysis of the CheckMate 9ER trial.

As Robert J Motzer, MD, Memorial Sloan Kettering Cancer Center, New York, NY, and colleagues wrote, “In the primary analysis of CheckMate 9ER, nivolumab plus cabozantinib showed superior progression-free survival, overall survival, and objective response over sunitinib.” The updated data on overall survival, efficacy, and safety are reported as a preplanned final analysis.

The ongoing, phase 3 CheckMate 9ER trial enrolled 651 patients with previously untreated advanced or metastatic renal cell carcinoma from 125 hospitals between September 11, 2017, and May 14, 2019. Patients were randomized on a 1:1 basis to received either 240 mg nivolumab intravenously every 2 weeks plus 40 mg cabozantinib orally once daily (n = 323), or 50 mg sunitinib orally once daily (n = 328). The primary end point was progression-free survival with secondary end points including overall survival and safety.

At the data cut-off date of June 24, 2021, the median follow-up duration was 32.9 months. Median overall survival was 37.7 (95% confidence interval [CI], 35.5 to not estimable [NE]) months in the nivolumab-cabozantinib group, compared to 34.3 (95% CI, 29 to NE) months in the sunitinib group (hazard ratio [HR], 0.70; 95% CI, 0.55 to 0.90; P = .0043). The updated median progression-free survival was 16.6 (12.8 to 19.8) months in the nivolumab-cabozantinib group compared to 8.3 (7.0 to 9.7) months in the sunitinib group (HR, 0.56; 95% CI, 0.46 to 0.68; P <.0001).

In the nivolumab-cabozantinib group, grade 3/4 treatment-related adverse events occurred in 65% of patients, compared to 54% in the sunitinib group. The most common grade 3/4 adverse events were hypertension, palmar-plantar erythrodysesthesia, and diarrhea. Serious adverse events occurred in 22% of patients in the nivolumab-cabozantinib group, and 10% of the sunitinib group.

These results further support, Dr Motzer at al wrote, “the combination [of nivolumab plus cabozantinib] in the first-line treatment of advanced renal cell carcinoma.”

Source:

Motzer RJ, Powles T, Burotto M, et al. Nivolumab plus cabozantinib versus sunitinib in first-line treatment for advanced renal cell carcinoma (CheckMate 9ER): Long-term follow-up results from an open-label, randomised, phase 3 trial. Lancet Oncol. Published online June 7, 2022. doi:10.1016/S1470-2045(22)00290-X