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Nivolumab plus ipilimumab improved outcomes in patients with advanced renal cell carcinoma (aRCC) who were ineligible for nephrectomy, according to results of a post hoc analysis presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
“Patients with aRCC who are ineligible for nephrectomy represent a population with high unmet medical need,” Laurence Albiges, MD, PhD, of Gustave Roussy in France, and presenter of the study, said.
The phase 3 CheckMate 214 trial previously demonstrated that nivolumab plus ipilimumab improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared with sunitinib in patients with clear cell aRCC. This 4-year, nonprespecified, post hoc analysis evaluated whether patients with a large target kidney lesion(s) who were ineligible for nephrectomy benefited from nivolumab plus ipilimumab.
The baseline characteristics of the post hoc analysis cohort were similar to the larger population, with a median age of 64 and 76% were male. Most patients’ disease was categorized as intermediate (54%) or poor (45%) risk, and the majority at a minimum of 2 target lesions (97%).
Treatment with nivolumab plus ipilimumab resulted in a decrease in target kidney lesion size of ≥30% in 35% of patients compared with 20% of patients who received sunitinib. This translated to an ORR of 34.0% with nivolumab plus ipilimumab compared with 14.5% with sunitinib. The ORRs in the intent-to-treat (ITT) population were 39.1% and 32.4%, respectively, and 41.9% and 26.8% in the intermediate/poor risk groups.
Duration of response (DOR) was also improved with nivolumab plus ipilimumab, with a median of 20.5 months compared with 14.1 months with sunitinib. In the ITT and intermediate/poor risk groups, the DOR was not yet estimable for the nivolumab plus ipilimumab group compared with 23.7 months and 19.7 months, respectively, in the intermediate/poor risk group.
The median OS was 26.1 and 14.3 months in the nivolumab plus ipilimumab and sunitinib groups, respectively (hazard ratio [HR], 0.63; 95% CI, 0.40-1.00). In the ITT population, the median OS was not yet reached with immunotherapy compared with 38.4 months with sunitinib. In the intermediate/poor risk cohort, the median OS was 48.1 and 26.6 months with nivolumab plus ipilimumab and sunitinib, respectively.
PFS was similar between arms, with a median of 8.1 months with nivolumab plus ipilimumab compared with 11.9 months in the sunitinib arm, but this was not significant (HR, 0.99; 95% CI, 0.59-1.67). PFS was also similar in the ITT population, but was prolonged in the intermediate/poor risk cohort (11.2 vs 8.3 months; HR, 0.74; 95% CI, 0.62-0.88).
The frequency of adverse events (AEs), including those potentially immune-mediated, were similar to the full cohort, with no new safety signals.
“In the exploratory subgroup of patients with a target kidney lesion(s),” Dr Albiges concluded, “dual combination immunotherapy with nivolumab plus ipilimumab offers a benefit in kidney tumor reduction, ORR, DOR, and OS vs sunitinib.”
Disclosures: Multiple authors declared affiliations with industry. Please refer to the original abstract for a full list of disclosures.
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Albiges L, Tannir N, Burotto M, et al. Nivolumab + ipilimumab (N+I) vs sunitinib (S) for first-line treatment of advanced renal cell carcinoma (aRCC) in CheckMate 214: 4-year follow-up and subgroup analysis of patients (pts) without nephrectomy. Presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2020; September 19-21, 2020. Abstract 711P.