FREE DAILY AND WEEKLY NEWSLETTERS OFFERED BY CONTENT OF INTEREST
Did you find this article relevant? Subscribe to UroToday-GUOncToday!
The fields of GU Oncology and Urology are advancing rapidly including new treatments, enrolling clinical trials, screening and surveillance recommendations along with updated guidelines. Join us as one of our subscribers who rely on UroToday as their must-read source for the latest news and data on drugs. Sign up today for blogs, video conversations, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.
Additional combinations of these immuno-oncology agents are currently being investigated in advanced renal cell carcinoma. Avelumab, another PD-L1 antibody, was combined with axitinib, with sunitinib in the control arm (NCT02684006), and this trial is now fully accrued. This combination has garnered FDA breakthrough designation. Similarly, pembrolizumab was also combined with axitinib and was directly compared to sunitinib in another phase 3 trial that has completed accrual (NCT02853331). This trial is evaluating both PFS and OS as dual primary endpoints. Finally, a three-armed trial of lenvatinib/pembrolizumab versus lenvatinib/everolimus versus sunitinib is still actively recruiting patients (NCT02811861). This combination also has been granted FDA breakthrough designation.
Given the movement of immuno-oncology agents from second-line to first-line metastatic renal cell carcinoma patients, with outstanding efficacy and tolerability, it is logical to move even earlier into the adjuvant setting for those patients with high-risk features after nephrectomy. This is ongoing now with adjuvant, randomized, phase 3 trials of pembrolizumab versus placebo and also atezolizumab versus placebo (see below). Nivolumab is also being studied in a perioperative setting, where it is being administered just prior to surgery with adjuvant therapy to follow after cystectomy. This phase 3 trial utilizes nivolumab compared to observation without placebo. See below for more information on these promising clinical trials that hopefully will someday soon make the controversy of adjuvant therapy in high-risk renal cell carcinoma disappear.
Highlighted Adjuvant Therapy Trials for Patients with High-risk Renal Cell Carcinoma
- Pembrolizumab (NCT03142334)
- Atezolizumab (NCT03024996)
- Nivolumab (NCT03055013)
- Ravaud A et al. N Engl J Med 2016; 375:2246-54.
- Haas NB et al. Lancet 2016; 387:2008-16.
- Motzer RJ et al. J Clin Oncol 2017; 35:3916-23.
- Motzer RJ et al. N Engl J Med 2015; 373:1803-13.
- Motzer RJ et al. N Engl J Med. 2018 Apr 5;378(14):1277-1290
- Motzer RJ et al. J Clin Oncol 36, no. 6_suppl 2018; Feb 20 578-578.