Poster Presentation COSA 2015 ASM

Updated survival results from a randomized, dose-ranging phase II study of nivolumab (NIVO) in metastatic renal cell carcinoma (mRCC) (#212)

Elizabeth R Plimack 1 , Hans J Hammers 2 , Brian I Rini 3 , David F McDermott 4 , Bruce G Redman 5 , Timothy M Kuzel 6 , Michael R Harrison 7 , Ulka N Vaishampayan 8 , Harry A Drabkin 9 , Saby George 10 , Theodore F Logan 11 , Kim A Margolin 12 , Li-An Xu 13 , Ian M Waxman 13 , Robert J Motzer 14
  1. Fox Chase Cancer Centre, Philadelphia, PA, USA
  2. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA
  3. Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA
  4. Beth Israel Deaconess Medical Center, Boston, MA, USA
  5. University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA
  6. Northwestern University Feinberg School of Medicine, , Chicago, IL, USA
  7. Duke University Medical Centre, Durham, NC, USA
  8. Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA
  9. Medical University of South Carolina, Charleston, SC, USA
  10. Roswell Park Cancer Institute, Buffalo, NY , USA
  11. Indiana University Simon Cancer Center, Indianapolis, IN, USA
  12. Seattle Cancer Care Alliance, Seattle, WA, USA
  13. Bristol-Myers Squibb, Princeton, NJ, USA
  14. Memorial Sloan-Kettering Cancer Centre, New York, NY, USA

Aims: NIVO, a programmed death-1 immune checkpoint inhibitor, demonstrated encouraging clinical activity in a randomized phase II study in pts with mRCC pretreated with targeted VEGF pathway agents. Here we present updated survival results.

Methods: NIVO was administered at 0.3, 2, or 10 mg/kg IV Q3W until progression or toxicity to pts with clear-cell mRCC (≤ 3 prior systemic therapies, ≥ 1 agent targeting VEGF pathway). Primary endpoint (progression-free survival) was reported previously. Other endpoints included overall survival (OS), adverse event rate, and association oftumor PD-L1 expression with clinical outcomes. OS was calculated by Kaplan-Meier method. PD-L1 expression was measured in archival tumor tissue by immunohistochemistry (Dako). PD-L1 positivity was defined as ≥ 5% tumor membrane staining.

Results: 168 pts were randomized. Of the treated pts (n = 59, 54, and 54 at 0.3, 2, and 10 mg/kg, respectively), 55 (33%) continue on study; 14 (8%) remain on treatment. Median doses given (range) was 6 (1–54), 7.5 (1–56), and 8 (1–59) for 0.3, 2, and 10 mg/kg, respectively. 64% of pts were evaluable for PD-L1 expression, 27% of whom had PD-L1 expression ≥5%. Median OS (80% CI) was 29.9 mo (13.4–not available [NA]) in the PD-L1+ subgroup and 18.2 mo (12.7–27.2) in the PD-L1– subgroup across doses.

Conclusions: NIVO demonstrated OS benefit across dose levels and in PD-L1+ and PD-L1– pts with mRCC and 3 years minimum follow-up. Survival rates at 2 and 3 years compare favorably with other therapies in this setting of heavily pretreated pts with clear-cell mRCC and suggest potential for pts to achieve long-term survival with NIVO treatment.

Reused with permission from the American Society of Clinical Oncology (ASCO). This abstract was accepted and previously presented at the 2015 ASCO Annual Meeting. All rights reserved.