Cabozantinib Plus Nivolumab in Patients with Non-Clear Cell Renal Cell Carcinoma: Updated Results from a Phase 2 Trial.

Autor: Fitzgerald KN; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Lee CH; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Voss MH; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Carlo MI; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Knezevic A; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Peralta L; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Chen Y; Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Lefkowitz RA; Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Shah NJ; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Owens CN; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., McHugh DJ; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Aggen DH; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Laccetti AL; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Kotecha RR; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Feldman DR; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Motzer RJ; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: motzerr@mkscc.org.
Jazyk: angličtina
Zdroj: European urology [Eur Urol] 2024 Aug; Vol. 86 (2), pp. 90-94. Date of Electronic Publication: 2024 May 22.
DOI: 10.1016/j.eururo.2024.04.025
Abstrakt: Treatment options are limited for patients with non-clear cell renal cell carcinoma (nccRCC). Patients with nccRCC experienced a favorable objective response rate (ORR) in a phase 2 trial of cabozantinib plus nivolumab. We now report updated efficacy and safety results at median follow-up of 34 mo for patients with papillary, unclassified, or translocation-associated RCC. Cabozantinib and nivolumab were administered at standard doses to patients with metastatic nccRCC that had progressed on zero or one line of systemic therapy. The primary endpoint was the ORR according to Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and adverse events. Forty patients were treated. At median follow-up of 34 mo for survivors, the ORR was 48% (95% confidence interval [CI] 31.5-63.9%). Median PFS was 13 mo (95% CI 7-16); the 12-mo and 24-mo PFS rates were 51% (95% CI 34-65%) and 23% (95% CI 11-37%), respectively. Median OS was 28 mo (95% CI 23-43); the 18-mo and 36-mo OS rates were 70% (95% CI 53-82%) and 44% (95% CI 28-60%), respectively. No new safety signals were seen with cabozantinib and nivolumab. This extended follow-up analysis demonstrates promising efficacy, and highlights the potential for sustained responses with cabozantinib plus nivolumab in patients with metastatic nccRCC.
(Copyright © 2024. Published by Elsevier B.V.)
Databáze: MEDLINE
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