Bristol Myers Squibb helped pay for the phase-3, randomized, open-label trial of 651 patients, where the volunteers who received the combination had a median progression-free survival of 16.6 months compared with 8.3 months with sunitinib (P<0.001).
At 12 months, 57.6% of the volunteers getting the two drugs had progression-free survival versus 36.9% in the control group, researchers report in the New England Journal of Medicine.
The dual-drug therapy also lowered the overall risk of death by 40% (P=0.001) and produced a higher likelihood of response after a median follow-up of 18.1 months.
The adjusted rates of overall survival at the 12-month mark were 85.7% with nivolumab and cabozantinib and 75.6% with sunitinib alone (P=0.001). Objective response rates were 55.7% and 27.1% respectively (P<0.001).
A complete response was seen in 8.0% of the nivolumab-plus-cabozantinib group versus 4.6% with sunitinib.
Virtually every patient had an adverse event. The side effects were grade 3 or higher in 75.3% of the nivolumab-cabozantinib patients and 70.6% of the sunitinib recipients.
While 16.9% of sunitinib patients discontinued the trial because of side effects, the rate was 19.7% in the experimental group.
"Yet, the patient-reported outcome measures suggested that the toxic effects did not have a major adverse effect on quality of life," write the researchers, led by Dr. Toni Choueiri of the Dana-Farber Cancer Institute in Boston.
All of the tumors had a clear-cell component, which represents about 80% of renal-cell carcinomas.
The results, from 125 sites in 18 countries, were first reported September 19 at the European Society for Medical Oncology Virtual Congress.
SOURCE: https://bit.ly/3bPb3ac The New England Journal of Medicine, online March 3, 2021.
By Reuters Staff
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