Médical Oncologist Institute Gustave Roussy, Villejuif, France.
University Hospital 12 de Octubre, Madrid, Spain.
Paris , Ile-de-France, France
Background: Immune-checkpoint combination therapy (ICI-combo) is the new standard of care for mRCC in frontline setting. However, pts with poor PS (2) were excluded from pivotal trials. Hence, the activity and safety of ICI-combo in this group of pts is still unknown.
Methods: We performed a multicentre retrospective study of PS2 mRCC pts who received frontline ICI-combo, either nivolumab-ipilimumab (NI) or pembrolizumab-axitinib (PA) between 2017-2021. Patient’s characteristics, clinical outcomes and toxicity were retrospectively reviewed. We analysed overall response rate (ORR), progression-free survival (PFS), overall survival (OS) and grade3 adverse events (G3AEs) in pts treated with NI or PA. The association between LIPI (Lung Immune Prognostic Index) and ORR/PFS/OS was also evaluated.
Results: We identified 70 mRCC pts with PS2 treated with ICI-combo across 14 institutions. Forty-five and 25 pts were treated with NI and PA respectively. Median age at diagnosis was 63 years, 51(73%) were male, 17(24%) had prior nephrectomy and 50(71%) had synchronous metastatic disease at diagnosis. Respectively, 33% and 63% pts were intermediate and poor IMDC risk. 91% were clear-cell RCC, and only 7 pts had sarcomatoid features. At the time of analysis (median follow-up 11.1 months(mo)) 41% pts were dead.Median PFS (mPFS) and mOS in the entire cohort were 5.4 mo and 16.0 mo respectively; ORR was 31%. No significant differences in ORR, PFS, OS or G3AEs were seen between NI and PA(Table 1). LIPI was significantly associated with worse ORR (p=0.04) and PFS (p=0.0009).
Conclusion: We report the 1st cohort of PS2 mRCC pts treated with ICI-frontline. No significant differences in ORR, PFS or OS were seen between NI and PA. LIPI was significantly associated with ORR and PFS. Prospective real-world studies are needed to confirm these results.