Salvage Nivolumab/Ipilimumab After Prior Immune Checkpoint Inhibitor Therapy in Patients With Metastatic Renal Cell Carcinoma

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In a study reported in the Journal of Clinical Oncology, Gul et al found that salvage therapy with nivolumab/ipilimumab was capable of producing a response after prior programmed cell death 1 (PD-1) pathway inhibitor therapy in some patients with metastatic renal cell carcinoma.

Study Details

The retrospective analysis included 45 patients from five U.S. centers who had not received prior anti–CTLA-4 antibody treatment. Overall, 76% had received an anti–PD-1 antibody and 24% received an anti–programmed cell death ligand 1 (PD-L1) antibody either alone or in combination with other therapies. Best overall response on anti–PD-1 therapy was partial response in 53% of patients, stable disease in 27%, and progressive disease in 20%.

Key Findings

Median follow-up was 12 months. Among 44 evaluable patients receiving salvage nivolumab/ipilimumab, partial response was observed in 9 (20%), stable disease in 7 (16%), and progressive disease in 28 (62%). 

Among 24 patients with a partial response to prior therapy, partial response was observed in 4, stable disease in 2, and progressive disease in 17 with salvage therapy. Among 12 patients with stable disease on prior therapy, 3 had partial response, 5 had stable disease, and 4 had progressive disease. Among nine patients with progressive disease on prior therapy, two had a partial response and seven had progressive disease.

Median duration of response was 7 months (range = 2–17 months) and median progression-free survival was 4 months (range = 0.8–19 months). Among nine patients with partial response, six had ongoing response and five were receiving maintenance nivolumab at the time of analysis.

Immune-related adverse events of any grade were observed in 64% of patients, with the most common being diarrhea (16%), rash (13%), hepatotoxicity (9%), and pneumonitis (7%). Grade 3 or 4 immune-related adverse events were observed in 13%, with the most common being hepatotoxicity (7%) and pneumonitis, rash, diarrhea, thrombocytopenia, and colitis (2% each). No treatment-related deaths were reported.

The investigators concluded, “Ipilimumab and nivolumab demonstrated antitumor activity with acceptable toxicity in patients with metastatic renal cell carcinoma who had prior treatment with checkpoint inhibition.”

Brian I. Rini, MD, of Vanderbilt University Medical Center, is the corresponding author for the Journal of Clinical Oncology article.

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