CheckMate 9ER Trial Demonstrates Efficacy in Patients With RCC

Rana R. McKay, MD, associate professor of Medicine and medical oncologist at the University of California, San Diego, discusses the combination of nivolumab (Opdivo) and cabozantinib (Cabometyx) versus sunitinib (Sutent) in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).

The top-line data from the CheckMate 9ER study (NCT03141177) showed this combination induced a statistically significant improvement in radiographic progression-free survival (rPFS), overall survival (OS), and objective response rate (ORR) compared with sunitinib for these patients. The median rPFS by independent radiology review, which was the primary end point of the trial, was 16.6 months with the combination versus 8.3 months in the control arm, with a hazard ratio of 0.51. McKay says the investigator assessment of rPFS was similar, with 19.4 months versus 9.2 months for the combination versus sunitinib, respectively, and a hazard ratio of 0.46.

There was a statistically significant OS improvement as well. Although the medians have not been reached, the hazard ratio was 0.60. For the ORR, there was a statistically significant improvement, with an ORR of 55.7% with nivolumab and cabozantinib versus 27.1% with sunitinib. The complete response rate with the combination was 8%. The median time to response was also improved at 2.8 months, and the duration of response was close to 2 years with nivolumab and cabozantinib, according to McKay.

McKay says this trial enrolled a larger percentage of patients with RCC who had their primaries intact, at 30%, and 15% of patients with bone metastases.

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