medwireNews: Patients with previously untreated advanced renal cell carcinoma (RCC) derive greater long-term survival benefits from nivolumab plus ipilimumab than from sunitinib, according to the latest results from the phase III CheckMate 214 trial.
At a median follow-up of 32.4 months, 425 intermediate- or poor-risk patients (as per the IMDC criteria) treated with nivolumab plus ipilimumab had longer median overall survival (OS) than 422 patients given sunitinib, at unreached versus 26.6 months, with a hazard ratio (HR) of 0.66. The 30-month OS rate was 60% and 47%, respectively.
Progression-free survival was also significantly improved, write Robert Motzer (Memorial Sloan Kettering Cancer Center, New York, USA) and colleagues in The Lancet Oncology, at a median of 8.2 months in the combination group versus 8.3 months with sunitinib (HR=0.77), and 30-month rates of 28% versus 12%.
In all, 42% of patients treated with nivolumab plus ipilimumab achieved an objective response, compared with 29% in the sunitinib group. This included 48 (11%) complete responses in the combination group, compared with just five (1%) in the sunitinib group. Overall, treatment response was longer with combination therapy than sunitinib, with 52% versus 28% of patients experiencing a durable response of at least 18 months.
Similar results for all three co-primary endpoints were seen in the intention-to-treat analysis, which also included 249 patients with favorable-risk disease.
There were no new safety signals with nivolumab plus ipilimumab, and the researchers note that known grade 3 or 4 treatment-related adverse events arose early and generally resolved within the first 4–6 months of therapy. By contrast, patients in the sunitinib group experienced both early and chronic toxicity, despite dose adjustments, they say.
“The long-term overall survival benefits, high proportions of complete response and ongoing response, and paucity of chronic toxicity with nivolumab plus ipilimumab after extended follow-up compares favourably with available reports of other combination regimens in first-line advanced renal cell carcinoma,” write the researchers.
In an accompanying comment, Giuseppe Procopio (Fondazione IRCSS Istituto Nazionale dei Tumori di Milano, Milan, Italy) and colleagues note: “[T]he occurrence of complete responses in some patients and the efficacy reported in selected patient populations, including those with sarcomatoid features, add more evidence to support the combination of nivolumab and ipilimumab as a new first-line standard of care for patients with advanced renal cell carcinoma.”
By Catherine Booth
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