According to 3-year follow-up data from the CheckMate ER9 trial, benefits in survival and response with nivolumab plus cabozantinib for patients with advanced renal cell carcinoma were maintained and consistent with previous follow-ups.

Mauricio Burotto, MD, Bradford Hill Clinical Research Center, Santiago, Chile, presented the data on Saturday, February 18, 2023, at the 2023 ASCO Genitourinary Cancers Symposium in San Francisco, CA.

In this phase 3 trial, 651 patients with advanced renal cell carcinoma were randomized on a 1-to-1 basis to receive either 240 mg nivolumab every 2 weeks plus 40 mg cabozantinib daily (n = 323) or 50 mg sunitinib for 4 weeks in 6-week cycles (n = 328). The primary end point was progression-free survival (PFS), with overall survival (OS), objective response rate (ORR), and safety as secondary end points.

At a minimum follow-up duration of 36.5 months, the benefits seen in PFS and OS with nivolumab plus cabozantinib vs sunitinib were maintained in all intent-to-treat patients. The median PFS was 16.6 months vs 8.6 months, respectively (hazard ratio [HR]: 0.58; 95% confidence interval [CI], 0.48 to 0.71; P < .0001). The median OS was 49.5 months vs 35.5 months, respectively (HR, 0.70; 95% CI, 0.56 to 0.87; P = .0014). The ORR of the nivolumab plus cabozantinib arm was 56% compared with 28% in the suntinib arm, and 12% vs 5% of patients achieved complete responses, respectively.

The incidence of grade ≥3 treatment-related adverse events was 67% in the nivolumab plus cabozantinib arm vs 55% in the sunitinib arm. Discontinuation due to treatment-related adverse events occurred in 28% of patients for either nivolumab or cabozantinib (10% cabozantinib, 10% nivolumab, 7% nivolumab and cabozantinib) and 11% of patients for sunitinib.

Dr Burotto and coauthors stated, “These results continue to support [nivolumab plus cabozantinib] as a first-line treatment for patients with renal cell carcinoma.”

Source:

Burotto M, Powles T, Escudier B, et al. Nivolumab plus cabozantinib vs sunitinib for first-line treatment of advanced renal cell carcinoma (aRCC): 3-year follow-up from the phase 3 CheckMate 9ER trial. Presented at 2023 ASCO Genitourinary Cancers Symposium; February 17-19; San Francisco, CA. Abstract 603