medwireNews: Phase III trial results presented at the ESMO 2017 Congress support the use of nivolumab plus ipilimumab for the first-line treatment of patients with advanced or metastatic clear-cell renal cell carcinoma (RCC).
The co-primary endpoint of objective response among trial participants classified as intermediate- or poor-risk, as per the International Metastatic Renal Cell Carcinoma Database Consortium criteria, was achieved by 42% of the 425 patients who were randomly assigned to receive nivolumab 3 mg/kg alongside ipilimumab 1 mg/kg every 3 weeks for four doses, followed by nivolumab alone at the same dose every 2 weeks until disease progression or unacceptable toxicity.
This was significantly higher than the objective response rate of 27% observed for the 422 counterparts given sunitinib 50 mg/day on a 4 weeks on, 2 weeks off schedule.
The duration of response was also longer in the combination than sunitinib group, with the median not reached and 18.2 months, respectively.
The other co-primary endpoints, namely progression-free survival (PFS) and overall survival, were also significantly improved with nivolumab plus ipilimumab treatment relative to sunitinib, at a median of 11.6 versus 8.4 months and unreached versus 26.0 months, respectively. The corresponding hazard ratios were 0.82 and 0.63.
Presenting author Bernard Escudier (Institut Gustave Roussy, Villejuif, France) told the audience in Madrid, Spain, that the results were similar in the intention-to-treat population, which also included 249 favorable-risk participants, except that PFS did not differ significantly between treatment groups.
The incidence of treatment-related adverse events of grade 3–5 was lower among patients who received nivolumab plus ipilimumab, at 46% versus 63% for sunitinib-treated patients, but more patients in the combination arm discontinued treatment as a result of such side effects, at 15% versus 7%.
These findings of the CheckMate 214 trial support the use of nivolumab plus ipilimumab as “a new first-line standard of care option” for patients with advanced RCC, Escudier concluded.
Manuela Schmidinger, from the Medical University of Vienna in Austria, who discussed these results at the conference session, commended the authors for choosing sunitinib as the comparator, describing it as an “ideal and very brave” choice.
She agreed that checkpoint inhibition is “a new standard of care” for this patient population, and one that is likely to have “a massive impact,” but believes that “it is not the final picture yet.”
The discussant concluded that “once we [are] able to properly address the biology of a patient‘s individual tumor, we may pick out the best individual treatment among various first-line options,” such as sunitinib, nivolumab plus ipilimumab, or a combination of immunotherapy and tyrosine kinase inhibitors.
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