Safety and Efficacy of Nivolumab in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study
| Autor: | Nicholas J. Vogelzang, Mark R. Olsen, Joshua J. McFarlane, Edward Arrowsmith, Todd M. Bauer, Rohit K. Jain, Bradley Somer, Elaine T. Lam, Mark D. Kochenderfer, Ana Molina, Gurjyot Doshi, Brian Lingerfelt, Ralph J. Hauke, Vijay Gunuganti, Ian Schnadig, Peter Van Veldhuizen, Mark Fleming, Robert Galamaga, Mukul Gupta, Hugo Hool, Thomas Hutson, Joshua Zhang, M. Brent McHenry, Jennifer L. Johansen, Scott S. Tykodi |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Urology 030232 urology & nephrology Gastroenterology Cohort Studies 03 medical and health sciences 0302 clinical medicine Renal cell carcinoma Internal medicine Clinical endpoint Medicine Humans Adverse effect Carcinoma Renal Cell business.industry medicine.disease Rash Kidney Neoplasms Progression-Free Survival Clinical trial Regimen Clear cell renal cell carcinoma Nivolumab Oncology 030220 oncology & carcinogenesis medicine.symptom business |
| Zdroj: | Clinical genitourinary cancer. 18(6) |
| ISSN: | 1938-0682 |
| Popis: | Background The open-label, phase IIIb/IV CheckMate 374 study (NCT02596035) was conducted to validate the safety and efficacy of flat-dose nivolumab monotherapy 240 mg every 2 weeks (Q2W) in previously treated advanced/metastatic renal cell carcinoma (RCC). Three cohorts included patients with predominantly clear cell histology, non-clear cell histologies, or brain metastases. We report safety and efficacy from the CheckMate 374 advanced clear cell RCC (ccRCC) cohort. Patients and Methods Eligible patients received prior treatment regimens (1-2 antiangiogenic; 0-3 systemic) with progression on/after last treatment and ≤ 6 months of enrollment. Patients received nivolumab 240 mg Q2W for ≤ 24 months or until confirmed progression/unacceptable toxicity. The primary endpoint was incidence of high-grade (grade 3-5) immune-mediated adverse events (IMAEs). Exploratory endpoints included objective response rate, progression-free survival, and overall survival. Results Ninety-seven patients had advanced predominantly ccRCC; 75.3% received only 1 prior systemic regimen in the advanced/metastatic setting. After a median follow-up of 17 months (range, 0.4-26.9 months), no grade 5 IMAEs occurred, and 9.3% of patients reported grade 3/4 IMAEs (hepatitis, 4.1%; diabetes mellitus, 2.1%; nephritis and renal dysfunction, 1.0%; rash, 1.0%; adrenal insufficiency, 1.0%). The objective response rate was 22.7% (95% confidence interval [CI], 14.8%-32.3%). Three patients had a complete response; 19 had partial responses. The median progression-free survival was 3.6 months (95% CI, 2.0-5.5 months). The median overall survival was 21.8 months (95% CI, 17.4 months to not estimable). Conclusions This study validates the safety and efficacy of nivolumab 240 mg Q2W flat-dose monotherapy for previously treated advanced ccRCC and adds to previous safety and efficacy data using the 3 mg/kg Q2W dose. |
| Databáze: | OpenAIRE |
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