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.
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.
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.
- 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.