The combination of Cabometyx (cabozantinib) plus Opdivo (nivolumab) “is certainly going to become one of the new standards of care” for the treatment of advanced renal cell carcinoma now that the regimen is approved, according to an expert from the Dana-Farber Cancer Institute.
The Food and Drug Administration’s (FDA) recent approval of Cabometyx (cabozantinib) plus Opdivo (nivolumab) for the treatment of advanced renal cell carcinoma provides patients with another therapy option and should become one of the new standards of care, according to Dr. Toni Choueiri.
“If we go back 10 to 15 years ago, a patient with metastatic kidney cancer really did not have much (in terms of treatment) options,” Choueiri, director of the Lank Center for Genitourinary Oncology and director of the Kidney Cancer Center at Dana-Farber Cancer Institute in Boston, said in an interview with CURE®.
Drugs targeting vascular endothelial growth factor (VEGF) were approved as single agents for the treatment of patients with renal cell carcinoma starting around 2005 and 2006, according to Choueiri. Then, in late 2015, single agent immune checkpoint inhibitors started receiving approval to treat these patients. Recently, however, the FDA has started to approve combination therapies to treat renal cell carcinoma.
The combination of Cabometyx plus Opdivo becomes the third immunotherapy/VEGF doublet treatment approved by the agency, according to Choueiri.
“(Cabometyx and Opdivo) is certainly going to become one of the new standards of care,” he said.
The approval was based on results of the CheckMate 9ER trial, which showed that the Cabometyx-Opdivo combination induced a superior progression-free survival (the time from treatment to disease progression or worsening), overall survival and overall response rate in patients compared with the chemotherapy Sutent (sunitinib).
Patients who received the combination achieved a median progression-free survival of 16.6 months compared to 8.3 months for those who received Sutent. Moreover, the combination induced a confirmed overall response rate of 55.7% compared to 27.1% for Sutent. Neither treatment group had reached a median overall survival.
Quality of Life
Data recently presented at a medical conference also showed that treatment with the combination was more associated with improved quality of life than with Sutent.
The results showed that patients who received Cabometyx plus Opdivo experienced a delay in deterioration and a significant decreased risk for confirmed deterioration in health-related quality of life scores, including disease-related kidney cancer symptoms.
“There is some intriguing quality of life data that showed that this regimen also has a better quality of life,” Choueiri said. “These (are) what we call patient reported outcome; the voice of the patient (is) very important.”
Overall, he explained that he’s happy to have another combination regimen approved for the treatment of these patients and that treatment advances are extending survival.
“The picture is that people with metastatic kidney cancer, today — because of these drugs, whether single agent or combination — are living way longer, and that's what the message should be,” Choueiri concluded.
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