GETUG-AFU 26 (Nivoren) is a prospective phase 2 study (Clinical trial information: NCT03013335) assessing safety and efficacy of N in a broad mRCC patient population. This included patients with BM (previously treated or not, but not requiring steroids), with previous mTOR inhibitor, with a performance status (PS) of 2 as well as in previously highly pretreated patients. 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 patients had had a brain CT scan or MRI at baseline.
By May 2017, 710/733 patients had been enrolled to the study. However, up to December 2016, the time of the analyses, 588 pts had been enrolled including 55 pts with BM. Of those 55 pts, 10 pts (23%) were PS 2 and 25 (58%) PS 1, and 34.5% were enrolled in 2nd line therapy, 36.4% were enrolled in 3rd line therapy and 29.1% were enrolled in a later line therapy. No previous treatment for BM was given in 67% (n = 37), while 9% had previous brain surgery (n = 5 ;) or brain radiation (n = 17 (31%)). Median duration of therapy in BM pts was 2.4 months (varying from 0 to 9) with a 3-months progression free survival (PFS) of 60% (C.I 95%: 45 – 73). Median OS was 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 17 pts.
This is the largest study to report preliminary safety and efficacy of N in mRCC pts with BM. Safety of N in this patient population appeared to be acceptable, although some pts did require steroids because of progressive disease. Objective response in the brain was observed in 23% of patients. Further follow-up is required to determine the real benefit of N in this group of patients.
Presented By: Bernard J. Escudier, Gustave Roussy Cancer Campus, Villejuif, France
Written By: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre
at the 2017 ASCO Annual Meeting - June 2 - 6, 2017 – Chicago, Illinois, USA