FDA approves Opdivo, Yervoy combination for kidney cancer

April 17 (UPI) -- The Food and Drug Administration has approved a combination of two immunotherapy drugs, ipilimumab and nivolumab, to treat metastatic kidney cancer.

The FDA approved the injection combination Monday based on the CheckMate 214 trial. The Phase 3 trial results were published Monday in the New England Journal of Medicine.

The lifetime risk for developing kidney cancer is 1 in 48 among men and 1 in 83 among women, according to the American Cancer Society. And about 14,970 people will die each year because of the disease in the United States.

"The approval of this combination immunotherapy is the most significant advance for the treatment of kidney cancer over the last 10 years," study leader Dr. Hans Hammers, co-head of the Kidney Cancer Program at University of Texas Southwestern in Dallas said in a press release. "Not only is this therapy superior than the current the standard of care, but patients experienced also a better quality of life. However, serious side effects can occur which require timely diagnosis and expertise in their management."

Researchers enrolled 847 people in the study who had previously untreated advanced RCC evaluated as intermediate or poor-risk. A total of 425 received nivolumab plus ipilimumab every three weeks for four doses followed by nivolumab monotherapy every every two weeks. The remaining 422 received the oral drug sunitinib for four weeks followed by two weeks off every cycle.

Forty-two percent of participatns given the combination drug regimen responded favorably to it, and 9 percent of those with a good response experienced complete disappearance of their tumors.

At least 20 percent of those treated with the combination experienced side effects, including fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia and decreased appetite.

Combination immunotherapy with nivolumab and ipilimumab has already been approved by the FDA for the treatment of melanoma, and is also being tested against other cancers.

The study was sponsored by Bristol-Myers Squibb and Ono Pharmaceutical, the manufacturers of the two drugs.