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Patients who have advanced renal cell carcinoma (aRCC) with brain metastases may benefit from combination therapy with nivolumab and ipilimumab (NIVO + IPI), new study results presented at the 2019 American Society of Clinical Oncology in Chicago suggest.
The findings are from an interim analysis of CheckMate 920, an ongoing phase 3b/4 clinical trial. Investigators presented findings from 28 patients with previously untreated advanced RCC and asymptomatic brain metastases. Patients received treatment with NIVO 3 mg/kg + IPI 1 mg/kg every 3 weeks for 4 doses, followed by NIVO 480 mg every 4 weeks until disease progression, unacceptable toxicity, or for a maximum of 2 years. The primary end point was high-grade immune-mediated adverse events (IMAEs).
With a minimum follow-up of 6.5 months, grade 3-4 IMAEs observed in 1 or more patients included diarrhea, colitis, diabetic ketoacidosis, immune-mediated hepatitis, hypophysitis, and rash, Hamid Emamekhoo, MD, of the University of Wisconsin School of Medicine in Madison, and colleagues reported in a poster presentation. Median overall survival has not been reached.
The investigators observed no case of treatment-related grade 5 IMAEs.
The cohort had an objective response rate of 28.6%. Median progression-free survival in all treated patients was 9 months.
In their study abstract, Dr Emamekhoo’s team concluded that “NIVO + IPI showed a safety profile consistent with previous reports of this dosing regimen, with encouraging anti-tumor activity.”
The investigators noted that previous clinical trials of patients with aRCC have mostly excluded patients with brain metastases.
Reference
Emamekhoo H, Olsen M, Carthon BC, et al. Safety and efficacy of nivolumab plus ipilimumab (NIVO+IPI) in patients with advanced renal cell carcinoma (aRCC) with brain metastases: Interim analysis of CheckMate 920. Presented at the 2019 American Society of Clinical Oncology annual meeting in Chicago, May 31 to June 4. Abstract 4517.
This article originally appeared on Renal and Urology News
