The FDA has approved the first immuno-oncology combination therapy for patients with advanced renal cell carcinoma. The Phase III CheckMate-214 clinical trial was conducted by Bristol-Myers Squibb (Uxbridge, UK) and aimed to find an alternative first line treatment for intermediate- and poor-risk advanced renal cell carcinoma (RCC).
Patients in the trial received four cycles of the Opdivo ® (nivolumab) + low-dose Yervoy™ (ipilimumab) combination, followed by nivolumab maintenance therapy. In the combination arm of the trial, 79% of patients received all four doses of nivolumab + ipilimumab and went on to the nivolumab monotherapy phase.
The nivolumab + ipilimumab combination demonstrated a significant and unprecedented increase in overall survival (OS) in this patient population compared with Sutent® (sunitinib), the current standard of care. Specifically, the nivolumab + ipilimumab combination reduced the risk of death by 37% versus sunitinib.
The immunotherapy combination also delivered durable responses with a higher objective response rate compared with sunitinib. An OS benefit was observed regardless of PD-L1 expression level. The combination was also associated with fewer overall Grade 3 or 4 adverse events in comparison with sunitinib (65% versus 76%).
“Our goal is to provide cancer patients with medicines that have the potential to extend their lives. As the first treatment option to increase OS for subgroups of patients with advanced RCC compared to sunitinib, the nivolumab plus low-dose ipilimumab combination helps deliver on that promise,” commented Johanna Mercier (Bristol-Myers Squibb).
Mercier continued: “This approval demonstrates our commitment to bringing immuno-oncology treatments that may improve outcomes to a broader range of RCC patients.”
“Physicians treating advanced RCC have had few options to help achieve the goal of improved survival,” commented Robert Motzer (Memorial Sloan Kettering Cancer Center, NY, USA).
He continued: “Data from the CheckMate -214 trial demonstrated superior OS with nivolumab +ipilimumab, showing the potential for the combination to become a new standard of care for patients with intermediate- and poor-risk advanced RCC. What’s more, the combination resulted in fewer overall Grade 3 and 4 adverse reactions compared to sunitinib. Because of these encouraging results, we now have a new treatment option for newly diagnosed advanced RCC patients across PD-L1 expression levels.”
“Kidney cancer is the deadliest of all urological cancers, and too many patients are faced with this grim diagnosis. Today’s approval of Opdivo + Yervoy for advanced RCC has the potential to transform the first-line treatment landscape for kidney cancer. But for patients, it is more than just a new therapy option – it represents hope for a longer life,” concluded Dena Battle (KCCure).