Significant and clinically meaningful
The study was funded by Bristol-Myers Squibb, which makes Opdivo. It was to be presented at the European Cancer Congress in Vienna, and is being published simultaneously in the New England Journal of Medicine.
The new findings "are significant and clinically meaningful to patients and health care professionals alike," senior researcher Dr Padmanee Sharma, of the University of Texas M.D. Anderson Cancer Centre in Houston, said in a meeting news release.
Sharma, a professor in the departments of genitourinary medical oncology and immunology, believes that the study results may "change the treatment of patients with advanced kidney cancer, whose disease has progressed on prior treatment".
In the new trial, Sharma's team compared Opdivo against Afinitor in more than 800 people with advanced kidney cancer. All of the patients had seen their tumour progress despite initial standard treatments.
Opdivo did seem to improve outcomes for patients, with median survival rising from 19.6 months for those taking Afinitor to 25 months among patients taking Opdivo, the researchers reported.
The gap between the two drugs shrank, however, when the study focused on what's known as "progression-free survival" time spent with the disease being in check. In that case, average progression-free survival was 4.6 months for those taking Opdivo, and 4.4 months for those on Afinitor, the study authors said.
No drug-related deaths
The data also showed that a greater proportion of patients had tumour shrinkage if they were taking Opdivo compared to people on Afinitor.
Serious side effects occurred in 19 percent of patients taking Opdivo versus 37 percent of those taking Afinitor. The most common side effects were fatigue, nausea and severe itching among those taking Opdivo; and fatigue, anemia and inflammation of the mucous membranes of the mouth for those taking Afinitor, the researchers said.
There were no drug-related deaths in the Opdivo group, but two occurred in the Afinitor group.
One expert in kidney cancer care said the new trial results are welcome news.
"Treatment options for metastatic kidney cancer remain inadequate for most patients," noted Dr William Oh, chief of haematology and medical oncology at the Icahn School of Medicine at Mount Sinai in New York City.
"Available drugs have limited activity or excess toxicity and new therapies are urgently needed," he said.
The new study finds that Opdivo may fight kidney tumours, too, and "this drug is better tolerated", Oh said.
"Having Opdivo available for our patients will be an important step forward," he believes.
And when will the drug become available?
According to Sharma, "although we cannot speculate at this time on when nivolumab [Opdivo] might enter the clinic, we hope that this study will quickly lead to approval of nivolumab as a standard of care therapy for these patients."
Image: Diagram of kidneys and blood cells from Twitter