ASCO 2017: Safety and efficacy of nivolumab for metastatic renal cell carcinoma (mRCC): Real world data from an Italian expanded access program (EAP)

Chicago, IL ( Since the phase III clinical trial in 2015 of nivolumab vs everolimus as second line therapy for advanced renal cell carcinoma (RCC) demonstrated a survival benefit for nivolumab [1], expanded access programs (EAP) in certain countries have made the drug available to patients prior to market availability. At today’s 2017 ASCO annual meeting genitourinary cancer poster session, Dr. De Giorgi and colleagues from Italy presented their findings regarding the safety and efficacy in a real world, EAP setting.

Inclusion criteria for this EAP program was (i) age ≥18 years, and (ii) relapse after a minimum of one prior systemic treatment for metastatic RCC (mRCC). Nivolumab 3 mg/kg was administered intravenously every 2 weeks, and patients included in the analysis were those who had received ≥ 1 dose of nivolumab. Across 95 Italian sites, 389 patients were enrolled. The median age was 65 years (range: 34-85) and 18% were aged ≥ 75 years. The majority of patients had clear-cell RCC (92%), 50% had bone metastases and 8% had brain metastases. Seventy-nine percent of patients had received more than one previous systemic therapy. Median follow-up was 7 months (range: 1-16), median number of doses received was 10 (range: 1-31), 21% of patients were treated beyond progression, 5% of patients discontinued treatment secondary to adverse events, 17% had complete (n=1) or partial response to nivolumab, and 31% had stable disease. The 6- and 9-month survival rates were 83% and 77%, respectively, and there was no difference in survival regarding age, bone/brain metastases or number of prior therapies.

In conclusion, the Italian EAP provides real-world experience and generalizability for the results reported in the prior phase III clinical trial [1]. This is an important arena for patients with pre-treated (and failed) systemic therapy, considering that the survival outcomes are typically dismal. Importantly, among patients that were either poorly (elderly, bone metastases) or not represented (brain metastases) at all in the clinical trial, nivolumab was safe and demonstrated a degree of oncologic efficacy.

Presented By: Ugo De Giorgi, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy

Co-Authors: Sarah Scagliarini, Umberto Basso, Luca Galli, Claudia Mosillo, Claudia Caserta, Sabrina Rossetti, Annalisa Guida, Alessandra Bearz, Sebastiano Buti, Giovanni Lo Re, Francesca Valcamonico, Alketa Hamzaj, Francesco Cognetti, Francesca Rastelli, Giuseppe Fornarini, Camillo Porta, Gabriella Del Bene, Daniele Turci, Giuseppe Procopio, Italian EAP RCC Group

Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre
Twitter: @zklaassen_md

at the 2017 ASCO Annual Meeting - June 2 - 6, 2017 – Chicago, Illinois, USA

1. Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med 2015 Nov 5;373(19):1803-1813.