BioPharma

ASCO: Newly approved drug for renal cell carcinoma lowers death rate

Patients with previously treated advanced renal cell carcinoma have a new treatment option with cabozantinib — a kinase inhibitor shown to improve overall survival compared to everolimus, as a Cleveland Clinic researcher noted at ASCO 2016 over the weekend.

For patients with advanced, previously treated renal cell carcinoma, cabozantinib is a newer treatment option already shown in a phase 3 clinical trial to improve progression-free survival and objective response rate compared with everolimus. Now, that trial also meets its secondary endpoint, showing a significant benefit with cabozantinib versus everolimus in median overall survival.

“It’s one of the first drugs to show a survival benefit in that setting — along with nivolumab, which was approved last November — adding to the limited therapy options for these patients,” Dr. Brian Rini, oncologist at Cleveland Clinic’s Department of Hematology and Oncology, said. Rini presented results of the trial Sunday at the 2016 American Society of Clinical Oncology annual meeting in Chicago.

The U.S. Food and Drug Administration on April 26 approved cabozantinib for use as second-line treatment for patients with advanced renal cell carcinoma, based on these trial results. This follows the agency’s 2012 approval of the drug for the treatment of metastatic medullary thyroid cancer.

The trial, called METEOR, examined 658 previously treated patients who were randomized to either cabozantinib or everolimus. Median overall survival in this trial was 21.4 months for patients receiving cabozantinib, versus 16.5 months for everolimus. Those on cabozantinib also saw a 33 percent reduction in the rate of death and a higher 18-month survival rate.

No new adverse events were reported, however the drug has its toxicity challenges. Fatigue and diarrhea are the big ones. Fatigue is usually managed with dose reductions, and for diarrhea, clinicians can prescribe supportive medications.

“While not toxic in everyone, it’s a balance of risk and benefit, and we will see how it plays out now that it’s available in terms of where people use it, in whom do they use it, and is the toxicity worth the benefit,” said Rini.

While not conclusive evidence, the longer progression-free survival and overall survival with cabozantinib seen in this trial support the idea that targeting several tyrosine kinase inhibitors may help delay the usual drug resistance for which this disease is notorious, according to Rini.

What remains to be determined is who might benefit most from this treatment. Rini noted that there are no biomarkers that were developed for cabozantinib. Also to be determined is the best treatment sequence for these drugs — as well as whether or not combination therapy will be an effective and viable approach. However, this is certainly good news in that there is a new option for patients with previously treated advanced renal cell carcinoma, Rini said.

Images: Cleveland Clinic, Flickr user Bilal Kamoon

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