No significant differences in overall response rate, progression free survival, or overall survival were observed between nivolumab-ipilimumab and pembrolizumab-axitinib when used as first-line therapy in metastatic renal cell carcinoma (mRCC) patients with poor performance status (PS), according to findings presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium.

Since patients with poor PS (≥2) were excluded from trials analyzing this new standard of care for mRCC treatment, the study aimed to assess the efficacy and safety of immune checkpoint combination therapy in this group of patients. The multicenter, retrospective study included mRCC patients with PS 2 or greater who were treated with either nivolumab-ipilimumab (NI) or pembrolizumab-axitinib (PA) as first-line therapy between 2017 and 2021.

Overall response rate (ORR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and grade 3 or greater treatment-related adverse events (AEs) were assessed in patients who received NI or PA. Additionally, the study evaluated the association between Lung Immune Prognostic Index (LIPI) and ORR, PFS, and OS.

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A total of 56 mRCC patients with PS 2 or greater who received NI (n=36) or PA (n=20) were included in the analysis. The authors reported that, at the time of analysis (median follow-up, 11.1 months), 45% of patients had died.

Findings revealed ORRs of 27%, 42%, and 20% for the entire cohort, the PA treatment cohort, and the NI treatment cohort, respectively. It was noted that the difference in ORR between treatment options was not found to be statistically significant (P =.157).

For the entire cohort, the median PFS was reported to be 4.4 months and the median OS was reported to be 15.9 months. Additional findings revealed no significant differences between the NI and PA groups when analyzing PFS, OS, or rate of grade 3 or greater AEs.

The study authors also reported that differences in OS and PFS according to IMDC risk score were not found to be significant (P =.818). “However, LIPI was significantly associated with OS (poor LIPI: HR, 8.18; P =.004) and PFS (intermediate LIPI: HR, 2.4; P =.048 and poor LIPI: HR, 8.59; P <.001),” the authors stated. Additionally, LIPI was found to be predictive of response in patients who received NI (P =.024).

“Prospective real-world studies are needed to confirm these results,” the investigators concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Carril L, Colomba E, Romero-Ferreiro C, et al. Efficacy of first-line combination therapy in metastatic renal cell carcinoma (mRCC) patients (pts) with poor performance status (PS). Presented at: ASCO-GU 2022; February 17-19, 2022; Abstract 320.

This article originally appeared on MPR