Nivolumab plus ipilimumab as first-line therapy of advanced renal cell carcinoma

The final efficacy and safety results of the phase 3 CheckMate trial, recently published on The Annals of Oncology, confirm a substantial survival benefit with durable responses for nivolumab plus ipilimumab versus sunitinib in patients with previously untreated advanced renal carcinoma.

The CheckMate trial involved 1096 patients with previously untreated advanced renal carcinoma, randomized to receive nivolumab plus ipilimumab or sunitinib; after a median follow-up of 9.3 years, overall survival probabilities were 31.4% versus 19.5% in intention-to-treat patients, 30.2% versus 18.7% in intermediate/poo-risk patients and 35.3% versus 21.8% in favorable-risk patients. Progression-free survival at 96 months were 22.7% versus 9.0% (intention-to-treat), 25.4% versus 8.5% (intermediate/poor-risk), and 12.5% versus 11.3% (favorable-risk). Duration of response was significantly longer in all groups and incidence of treatment-related adverse events was higher in sunitinib group. As authors point out, this is the longest phase 3 trial follow up of a first-line checkpoint inhibitor combination in advanced renal cell carcinoma. «The 9-year follow-up data from CheckMate 214 provide a unique and comprehensive long-term perspective on the efficacy and safety of the nivolumab plus ipilimumab combination in patients with advanced renal cell carcinoma», authors say. «These results not only reinforce the sustained clinical benefit of this immunotherapy combination but also offer valuable insights into the long-term outcomes and safety profile, confirming the durability of immunotherapy responses in this patient population. This extended and final follow- up stands as a benchmark in the field, informing treatment decisions and setting new standards for long-term efficacy assessment in advanced renal cell carcinoma», they conclude.