Certain patients with renal cell carcinoma (RCC) treated with nivolumab beyond RECIST-defined first disease progression may experience clinical benefit, a study published in JAMA Oncology has shown.1

Treatment is typically discontinued when patients demonstrate disease progression; however, response patterns with immunotherapy may differ from those of other treatment. Therefore, researchers sought to evaluate the safety and potential benefit of nivolumab therapy beyond investigator-assessed first progression in patients with metastatic RCC.

For the study, researchers conducted a subgroup analysis of a blinded, multicenter, phase 2 dose ranging trial that randomly assigned 168 patients to receive nivolumab 0.3, 2, or 10 mg/kg intravenously every 3 weeks. A total of 154 patients experienced disease progression, of which 36 were treated beyond first progression.

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Prior to first progression, the RECIST-defined objective response rate was 14% and median progression-free survival was 4.2 months (95% CI, 2.8-5.5) among patients treated beyond progression. Among those not treated beyond progression, the RECIST-defined objective response rate and median progression-free survival was 16% and 2.6 months (95% CI, 1.5-3.9), respectively.

Researchers found that after initial progression, 69% of patients treated with nivolumab beyond progression demonstrated sustained reductions in tumor burden or stabilization in target lesion size.

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In regard to safety, the incidence of treatment-related adverse events was higher in patients treated beyond first progression than those not treated beyond progression; however, when adjusting for length of treatment exposure, the incidence of nivolumab-related adverse events was actually lower in patients treated beyond progression.   


  1. George S, Motzer RJ, Hammers HJ, et al. Safety and efficacy of nivolumab in patients with metastatic renal cell carcinoma treated beyond progression [published online ahead of print May 12, 2016]. JAMA Oncol. doi: 10.1001/jamaoncol.2016.0775.