Safety and Efficacy of Nivolumab in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study
Document Type
Article
Abstract
BACKGROUND: The open-label phase IIIb/IV CheckMate 374 study (NCT02596035) was conducted to validate the safety and efficacy of flat-dose nivolumab 240 mg every 2 weeks (Q2W) in previously treated advanced/metastatic renal cell carcinoma. Three cohorts included patients with predominantly clear cell histology, non-clear cell histologies, or brain metastases. We report safety and efficacy from the advanced non-clear cell RCC (nccRCC) cohort of CheckMate 374. METHODS: Eligible patients received 0 to 3 prior systemic therapies. Patients received nivolumab 240 mg Q2W for ≤24 months or until confirmed progression or unacceptable toxicity. The primary endpoint was incidence of high-grade (grade 3-5) immune-mediated adverse events (IMAEs). Exploratory endpoints included objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). RESULTS: Forty-four patients had advanced nccRCC (papillary [n = 24], chromophobe [n = 7], unclassified [n = 8], other [n = 5]); 34.1% received ≥1 prior systemic regimen in the advanced/metastatic setting. With median follow-up of 11 (range, 0.4-27) months, no all-cause grade 3-5 IMAEs or treatment-related grade 5 adverse events were reported. ORR was 13.6% (95% confidence interval [CI], 5.2-27.4), with 1 complete response (chromophobe) and 5 partial responses (papillary [n = 2], chromophobe [n = 1], collecting duct [n = 1], and unclassified [n = 1] histology). Median PFS was 2.2 months (95% CI, 1.8-5.4). Median OS was 16.3 months (95% CI, 9.2-not estimable). CONCLUSIONS: Safety of flat-dose nivolumab 240 mg Q2W was consistent with previous results. Clinically meaningful efficacy was observed with responses in several histologies, supporting nivolumab as a treatment option for patients with advanced nccRCC, a patient population with high unmet need.
Medical Subject Headings
Carcinoma, Renal Cell (drug therapy); Cohort Studies; Humans; Kidney Neoplasms (drug therapy); Nivolumab (adverse effects); Progression-Free Survival
Publication Date
12-1-2020
Publication Title
Clinical genitourinary cancer
E-ISSN
1938-0682
Volume
18
Issue
6
First Page
461
Last Page
468.e3
PubMed ID
32718906
Digital Object Identifier (DOI)
10.1016/j.clgc.2020.05.006
Recommended Citation
Vogelzang, Nicholas J.; Olsen, Mark R.; McFarlane, Joshua J.; Arrowsmith, Edward; Bauer, Todd M.; Jain, Rohit K.; Somer, Bradley; Lam, Elaine T.; Kochenderfer, Mark D.; Molina, Ana; Doshi, Gurjyot; Lingerfelt, Brian; Hauke, Ralph J.; Gunuganti, Vijay; Schnadig, Ian; Van Veldhuizen, Peter; Fleming, Mark; Galamaga, Robert; Gupta, Mukul; Hool, Hugo; Hutson, Thomas; Zhang, Joshua; McHenry, M Brent; Johansen, Jennifer L.; and Tykodi, Scott S., "Safety and Efficacy of Nivolumab in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study" (2020). ENT and Skull Base Surgery. 19.
https://scholar.barrowneuro.org/ent-and-skull-base-surgery/19