Efficacy and Safety of Nivolumab in Patients with Metastatic Renal Cell Carcinoma and Brain Metastases: Preliminary Results from the GETUG-AFU 26 (Nivoren) Study.
METHODS: GETUG-AFU 26 (Nivoren) is a prospective phase 2 study assessing safety and efficacy of N in a broader mRCC patient population than those recruited in the pivotal phase 3, including pts with BM (previously treated or not, but not requiring steroids), with previous mTOR inhibitor, with PS 2 as well as in previously highly pretreated pts. N was given every 2 weeks at 3mg/kg, until disease progression or unacceptable toxicity. Treatment was allowed beyond progression in case of clinical benefit. All pts had brain CT scan or MRI at baseline.
RESULTS: Up to December 2016 , 588 pts have been enrolled including 55 pts with BM (35 (67%) ,6 (12%) and 11 (21%) with 1, 2 or > 2 BM, respectively. Of those 55 pts, 10 pts (23%) were PS 2 and 25 (58%) PS 1, and 16 patients (29%) had received more that 2 lines of therapy. No previous treatment for BM was performed in 67% (n = 37), while 9% had previous brain surgery (n = 5 ;) or brain radiation (n = 17 (31%). 2/55 pts never received N. Median duration of therapy in BM pts was 2.4 months (varying from 0 to 9) with a 3-months PFS of 60% (IC95% = 45 – 73). Median OS is not reached at the time of this analysis. Among 44 pts with assessment of response on BM, 10 (23%) had objective response while 21 (48%) had local progressive disease. Neurologic deterioration requiring steroids was observed in 15 pts (32%) . Updated data will be presented at the meeting.
CONCLUSIONS: This is the first large study to report preliminary safety and efficacy of N in RCC pts with BM. Safety of N in this pt population appears to be acceptable, although some pts do require steroids because of brain progressive disease. Objective response in the brain was observed in 23% of pts. Further follow up is required to determine the real benefit of N in this group of mRCC pts. Clinical trial information: NCT03013335.
Journal of Clinical Oncology 35, no. 15. May 30, 2017 [Epub]
Bernard J. Escudier, Sylvie Chabaud, Delphine Borchiellini, Gwenaelle Gravis, Christine Chevreau, Pierre Emmanuel Brachet, Lionnel Geoffrois, Brigitte Laguerre, Hakim Mahammedi, Sylvie Negrier, Frederic Rolland, Marine Gross Goupil, Muriel Habibian, Laurence Albiges
Gustave Roussy Cancer Campus, Villejuif, France; Centre Léon-Bérard, Lyon, France; Department of Medical Oncology, Centre Antoine-Lacassagne, Nice, France; Institut Paoli-Calmettes, Marseille, France; IUCT-Oncopôle /Institut Claudius Regaud, Toulouse, France; Centre François Baclesse, Caen, France; Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandœuvre-Lès-Nancy, France; Centre Eugène Marquis, Rennes, France; Centre Jean Perrin, Clermont-Ferrand, France; Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France; CHU Bordeaux, Bordeaux, France; Unicancer, Paris, France; Gustave Roussy Cancer Campus and University Paris-Sud, Villejuif, France
Journal of Clinical Oncology; DOI: 10.1200/JCO.2017.35.15_suppl.4563