• Patients on Opdivo lived months longer than those on Afinitor
  • Another trial finds Exelixis drug slows pace of same disease

A large study found that Bristol-Myers Squibb Co.’s drug Opdivo extends survival for people with advanced kidney cancer, a result that could provide new options for the hard-to-treat tumor.

The 821-patient study being presented Saturday at the European Cancer Congress in Vienna found that kidney cancer patients who had failed initial treatments lived more than five months longer if they took Opdivo, compared to taking a standard kidney cancer drug, Novartis AG’s Afinitor. Patients on Opdivo also reported better quality of life, according to the results.

Bristol-Myers said it plans to apply for approval for the new use of Opdivo, which already is prescribed for lung cancer and melanoma and costs about $150,000 a year. Using the drug for kidney cancer patients could eventually add more than $1.3 billion of sales for New York-based Bristol-Myers, according to a Sept. 22 report from David Risinger, an analyst at Morgan Stanley.

“This is the first study that really shows that we’re improving survival in patients” with kidney cancer, said Robert Motzer, an oncologist at Memorial Sloan Kettering Cancer Center in New York and the lead author of the study.

Of several newer drugs available for kidney cancer, almost all have been shown merely to slow tumor growth, Motzer said. Only one other drug has shown a survival benefit, and that drug was studied in a much narrower population.

New Class of Drugs

Opdivo is one of a new class of drugs that stimulate the immune system to attack cancers. It competes with Merck & Co.’s Keytruda, which is approved for advanced melanoma. The drugs are expected to be used in many different types of tumors and eventually become a mainstay of cancer care.

Patients who took Opdivo lived a median of 25 months, compared to 19.6 months for patients taking Afinitor, according to results that also are being published in the New England Journal of Medicine. In addition, 19 percent of Opdivo patients had serious side effects, compared to 37 percent who had bad side effects on Afinitor.

Common side effects with Opdivo in the study included fatigue, nausea and diarrhea. In previous trials, Opdivo has caused a variety of auto-immune effects, including severe lung inflammation in a number of cases.

Bristol-Myers announced on July 20 that it had stopped the trial early because the drug worked well. This is the first presentation of the full results from the company-sponsored study.

Thyroid Cancer Treatment

In a separate trial being presented at the meeting, a thyroid cancer drug from Exelixis Inc. also yielded positive results in kidney cancer patients who had failed other treatment. Interim results from the trial in 658 patients found that the drug, called Cometriq, slowed progression of the disease by 7.4 months, compared to 3.8 months for patients treated with Afinitor. Three out of five patients on Cometriq needed to reduce their doses due to side effects, compared to one in four people on Afinitor. Side effects of the Exelixis drug include hypertension, diarrhea and fatigue.

Novartis declined to comment directly on either trial. “We welcome all scientific insights that can improve outcomes for patients,” the Swiss company said in an e-mail.

The Cometriq trial, sponsored by Exelixis, hasn’t yet continued long enough to show definitely whether the medicine lengthens life, according to the results. Exelixis, a San Francisco-area biotech company, said it expects to complete its application for approval of the new use by the end of this year. The company also expects to file in Europe for the new use next year. 

More than 60,000 Americans develop kidney cancer each year, and more than 14,000 die a year, according to estimates from the American Cancer Society. Risk factors include smoking and obesity.

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