CheckMate 9ER: Nivolumab Plus Cabozantinib Maintains Status as First-line Treatment for aRCC

After a 3-year minimum follow-up period, results from the CheckMate 9ER trial show that nivolumab plus cabozantinib demonstrated increased efficacy benefits when compared with sunitinib alone for patients with advanced renal cell carcinoma (aRCC).

The study was led by Dr. Mauricio Burotto and presented at the 2023 International Kidney Cancer Symposium: North America.

The phase 3 CheckMate 9ER trial reported that over a 25.4-month minimum follow-up period (median, 32.9 months), first-line nivolumab plus cabozantinib benefited patients with aRCC more than sunitinib alone.

After a 3-year minimum follow-up period, researchers recorded survival, response per blinded independent central review (BICR), and safety.

In the trial, investigators followed a 1:1 ratio to randomize patients to receive either nivolumab 240 mg plus cabozantinib 40 mg or sunitinib 50 mg for 4 weeks in 6-week cycles until they exhibited disease progression or unacceptable toxicity. The maximum time frame for a patient to receive nivolumab was 2 years.

The study’s primary end point was progression free survival (PFS) by BICR, with secondary end points of overall survival (OS), objective response rate (ORR) by BICR, and safety.

Researchers found that patients in the nivolumab-plus-cabozantinib arm demonstrated increased efficacy benefits with a 36.5-month minimum follow-up period (median, 44.0 months) when compared with sunitinib alone.

The nivolumab-plus-cabozantinib group, with 323 participants, resulted in a median PFS of 16.6 months, a median OS of 49.5 months, and a median duration of response (DOR) of 22.1 months. The group’s ORR was 56%. In the sunitinib-alone group, consisting of 328 patients, the median PFS was 8.4 months, median OS was 35.5 months, and median DOR was 16.1 months. The group’s ORR was 28%.

Treatment-related adverse events were reported by 97% (67%) and 93% (55%) of patients in the nivolumab-plus-cabozantinib and sunitinib-alone cohorts, respectively.

Dr. Burotto and colleagues concluded that nivolumab plus cabozantinib maintained efficacy benefits in patients and led to an improved median OS by 11.8 months.