In patients with poor performance status and metastatic renal cell carcinoma (mRCC), frontline nivolumab+ipilimumab (NIVO+IPI) may provide comparable survival outcomes to pembrolizumab+axitinib (PEMBRO+AXI), investigators reported at IKCS Europe 2022.
Patients with poor performance status have been excluded from pivotal mRCC trials, so investigators performed a retrospective review of 45 patients who received NIVO+IPI and 25 who received PEMBRO+AXI at 14 centers during 2017 to 2021. Of the cohort, 36% had intermediate-risk and 64% poor-risk disease, according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria. Most patients (91%) had clear cell RCC. Only 7 patients had sarcomatoid features. Median age at diagnosis was 63 years, and 73% of patients were male. Clinicians diagnosed synchronous metastatic disease in 71%. Prior nephrectomy was performed in 24%.
During the follow-up period, 41% of patients died. Median progression-free survival (PFS) for the full cohort was 5.4 months and median overall survival (OS) was 16.0 months, Lucia Carril-Ajuria, MD, of the Institute Gustave Roussy, Villejuif, France, reported. The objective response rate (ORR) was 31%.
The investigators found no significant differences in PFS, OS, or ORR between the NIVO+IPI and PEMBRO+AXI groups. Grade 3 or higher adverse event rates also appeared comparable between groups.
IMDC risk group was not prognostic. Only intermediate/poor Immune Prognostic Index (IPI) was significantly associated with worse OS, PFS, and ORR, Dr Carril-Ajuria reported. Of the cohort, IPI was good, intermediate, and poor in 48%, 36%, and 17%, respectively.
“Prospective real-world studies are needed to confirm these results,” Dr Carril-Ajuria concluded in the poster.
Carril-Ajuria L, et al. Efficacy of frontline combination therapy in metastatic renal cell carcinoma (mRCC) patients (pts) with poor performance status. Presented at IKCS Europe 2022 in Antwerp, Belgium; April 22-24, 2022. Poster 12.