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By D’Ann George, PhD, Medical Writer

Dr. Toni Choueiri discusses the COSMIC-313 trial.

At the recent European Society of Medical Oncology congress in Paris, oncologists eagerly awaited results from the ground-breaking phase III COSMIC-313 trial for two reasons: 

  • it tested the effectiveness of a three-drug combination – cabozantinib (Cabometyx) plus nivolumab (Opdivo) and ipilimumab (Yervoy) – for the first time in people with intermediate to poor risk RCC (rental cell carcinoma) 
  • it pitted the triplet against a two-drug combination that is the current standard of care for these people in many countries – nivolumab and ipilimumab. 

With a broad smile on his face, principal investigator Dr. Toni Choueiri of the Dana-Farber Cancer Institute said COSMIC-313 showed a 27% decrease in the risk of progression or death favoring the triplet. 

“I believe this could be – could be – potentially practice changing, and add another important combination in the future,” he said.

The triplet  worked particularly well for people who were at intermediate risk versus poor risk, which Choueiri called counterintuitive since he expected that the triplet would be more active in poor-risk RCC patients. Oncologists assess a person’s risk level based on factors such as low red blood cell count and time from diagnosis to needing treatment.

Participants in the randomized, double-blind trial received either the triplet therapy or the doublet plus a placebo pill. Cabometyx is a targeted therapy that prevents blood vessels from forming to help tumors grow. The drug also may enhance the action of immunotherapy agents like nivolumab and ipilimumab,  which activate the immune system to fight cancer.

Dr. Eric Jonasch, an oncologist at MD Anderson Cancer Center who was not involved in the study, had a more circumspect response to the data. Although the trial met its primary endpoint of increased progression-free survival, “the complete response rate, which is something that we really look for in these trials, was relatively low,” he said. 

A person experiencing a complete response would have no more cancer visible on scans. 

Jonasch and Choueiri both pointed out the increased side effects among those who received the triplet therapy compared with standard of care, most notably diarrhea, rash, and increased liver function blood tests. Whether the triplet therapy improves overall survival is yet to be seen. Choueiri did not report this data because the trial is not complete yet.  “We need to wait for things like overall survival data to see how this is going to be used in clinical practice,” Jonasch said.

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