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Multicenter Study
. 2024 Jul 2;73(9):161.
doi: 10.1007/s00262-024-03741-2.

Long-term responders to nivolumab in previously treated advanced renal cell carcinoma: a sub-analysis of meet-URO15 study

Carlo Messina #  1 , Martina Catalano #  2 , Giandomenico Roviello  3 , Annalice Gandini  4 , Marco Maruzzo  5 , Ugo De Giorgi  6 , Paolo Pedrazzoli  7   8 , Andrea Sbrana  9 , Paolo Andrea Zucal  10   11 , Cristina Masini  12 , Emanuele Naglieri  13 , Giuseppe Procopio  14 , Michele Milella  15 , Fabio Catalano  4 , Lucia Fratino  16 , Stefania Pipitone  17 , Riccardo Ricotta  18 , Stefano Panni  19 , Veronica Mollica  20 , Mariella Soraru  21 , Veronica Prati  22 , Francesco Atzori  23 , Marilena Di Napoli  24 , Marco Messina  25 , Franco Morelli  26 , Giuseppe Prati  27 , Franco Nole  28 , Andrea Malgeri  29 , Marianna Tudini  30 , Francesca Vignani  31 , Alessia Cavo  32 , Alessio Signori  33 , Giuseppe Luigi Banna  34   35 , Pasquale Rescigno  36 , Sebastiano Buti  37   38 , Sara Elena Rebuzzi #  39   40 , Giuseppe Fornarini #  4
Affiliations
Multicenter Study

Long-term responders to nivolumab in previously treated advanced renal cell carcinoma: a sub-analysis of meet-URO15 study

Carlo Messina et al. Cancer Immunol Immunother. .

Abstract

Background: Although nivolumab prolongs overall survival (OS) in pretreated patients with metastatic renal cell carcinoma (mRCC), underlining clinical and biological features of long-term responses are still to be determined. This study aims to investigate clinical and pathological characteristics of mRCC patients who achieved long-term responses during nivolumab treatment.

Materials and methods: A retrospective analysis was performed on mRCC patients receiving nivolumab as second or further therapy line between May 2016 and January 2019 in 34 Italian Oncology Centres. Outcome assessments and logistic regression were performed to evaluate factors influencing long-term responses.

Results: A total of 571 patients with a median age of 61 years (range 17-85) were included in the analysis. With a median follow-up of 22.1 (1.0-89.0) months, 23.1% of patients were 2-year progression-free on treatment with nivolumab, hence they were categorized as long-term responders. Baseline characteristics, including age, gender, and histology, were similar between long- and short-term responders. Karnofsky Performance Status ≥ 80% was significantly associated with long-term response (p = 0.02), while bone metastases (p = 0.03), International mRCC Database Consortium intermediate-poor risk (p < 0.01) and Neutrophil-to-Lymphocyte Ratio ≥ 3.2 (p = 0.02) were associate with short-term responses. Long-term responders exhibited a median progression-free survival of 55.0 months versus 4.0 months of the short-term responders. The median OS was not reached in long-term responders while it was 17.0 months for short*term responders.

Conclusion: This retrospective analysis sheds light on factors associated with long-term response to nivolumab in mRCC. Understanding these clinical features will be essential for selecting patients who may mostly benefit from immunotherapy.

Keywords: Immunotherapy; Long-term response; Metastatic renal cell carcinoma; Nivolumab; Prognostic factors.

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Conflict of interest statement

Sebastiano Buti: has received honoraria for speaking at scientific events and advisory roles from AstraZeneca, Bristol Myers Squibb, Ipsen, Astellas, Merck, Eisai, MSD, Novartis, and Pfizer and research funding from Novartis and Pfizer, outside the present work. Giuseppe Luigi Banna: Speaker bureau: Astellas, Astrazeneca, Amgen. Patents: n. 4 patents with ST Microelectronics. Travel, Accommodations for scientific conferences: Merck, Janssen. Ugo De Giorgi: services as advisory/board member of Astellas, Bayer, BMS, IPSEN, Janssen, Merck, Pfizer, Sanofi, received research grant/funding to the institution from AstraZeneca, Roche, Sanofi, and travel/accommodations/expenses from BMS BMS, IPSEN, Janssen, Pfizer. Mariella Sorarù: honoraria as consultant or advisory role from Janssen; grant for participation at scientific events: Astellas Pharma, Sanofi, Roche Novartis, Ipsen, Janssen, Bristol Myers Squibb, Pfizer; research funding: Roche, Merck, Janssen.

Figures

Fig. 1
Fig. 1
Progression-free survival and overall survival and in entire population
Fig. 2
Fig. 2
Progression-free survival and overall survival in long-term responders
Fig. 3
Fig. 3
Progression-free survival and overall survival of short-term responders
See this image and copyright information in PMC

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