Safety and Efficacy of Nivolumab for Metastatic Renal Cell Carcinoma: Real-World Results From an Expanded Access Program

To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Early Access Program.

Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events (AEs) using CTCAE v.4.0.

A total of 389 patients were enrolled between July 2015 and April 2016, including 18% aged ≥75 years, 6.7% with non-clear cell RCC, 49.6% with bone and 8.2% with brain metastases, 79% after 2 or more previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment due to AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7 - 6.2), the 12-month overall survival rate was 63%. Comparable survival rates were reported among patients with non-clear cell histology, elderly patients, bone and/or brain metastases, prior first-line sunitinib or pazopanib, prior everolimus.

The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in non-clear cell mRCC, elderly, pretreated with everolimus and bone and/or brain metastases encourage the use of nivolumab in these categories of patients. This article is protected by copyright. All rights reserved.

BJU international. 2018 Jun 29 [Epub ahead of print]

Ugo De Giorgi, Giacomo Cartenì, Diana Giannarelli, Umberto Basso, Luca Galli, Enrico Cortesi, Claudia Caserta, Sandro Pignata, Roberto Sabbatini, Alessandra Bearz, Sebastiano Buti, Giovanni Lo Re, Alfredo Berruti, Sergio Bracarda, Francesco Cognetti, Francesca Rastelli, Giuseppe Fornarini, Camillo Porta, Daniele Turci, Cora N Sternberg, Giuseppe Procopio, Italian Nivolumab Renal Cell Cancer Early Access Program Group

Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola., Department of Medical Oncology, Azienda Ospedaliero-Universitaria "A. Cardarelli", Napoli., Department of Statistics, Regina Elena National Cancer Institute IRCCS, Rome., Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, Istituto Oncologico Veneto IOV IRCCS, Padova., Department of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana Spedali Riuniti S. Chiara, Pisa., Department of Medical Oncology, Policlinico Umberto I, Roma., Department of Medical Oncology, Azienda Ospedaliero-Universitaria di Santa Maria, Terni., Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Napoli., Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena., Department of Medical Oncology, Istituto Nazionale Tumori IRCCS, Aviano,., Medical Oncology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma., Department of Medical Oncology, CRO Pordenone-S.Vito Oncology, CRO IRCCS Aviano., Department of Medical Oncology, ASST Spedali Civili di Brescia, Brescia., Department of Medical Oncology, Azienda USL 8, Arezzo., Department of Medical Oncology, Regina Elena National Cancer Institute IRCCS, Rome., Department of Medical Oncology, Fermo Area Vasta 4, Fermo., Department of Medical Oncology, Azienda Ospedaliero-Universitaria San Martino IST IRCCS Genova., University of Pavia and IRCCS San Matteo University Hospital Foundation, Pavia., Department of Medical Oncology, Ospedale Santa Maria delle Croci, Ravenna., Department of Medical Oncology, San Camillo Forlanini Hospital, Roma,., Department of Medical Oncology, Istituto Nazionale Tumori IRCCS Milano (Procopio); all in Italy.