In an analysis of the phase II GETUG-AFU 26 NIVOREN study reported in the Journal of Clinical Oncology, Flippot et al found that nivolumab had limited activity in patients with previously untreated brain metastases from clear cell renal cell carcinoma.
The study assessed nivolumab in patients with metastatic clear cell renal cell carcinoma that had failed to respond to VEGF-directed therapies. The analysis included a subgroup of 73 patients with asymptomatic brain metastases from the trial, consisting of 39 with previously untreated metastases (cohort A) and 34 with prior treatment (cohort B).
The primary outcome measure for the analysis was intracranial response rate with nivolumab in cohort A.
The intracranial response rate in cohort A was 12%, with no objective responses being reported in patients with multiple brain lesions or lesions larger than 1 cm. At data cutoff, 30 (77%) of 39 patients in cohort A had intracranial progression, including 14 (47%) of 30 with new brain metastases. In cohort B, 26 (77%) of 34 had progression, including 9 (35%) of 26 with new brain metastases.
Median intracranial progression-free survival was 2.7 months in cohort A and 4.8 months in cohort B (adjusted hazard ratio [HR] = 2.04, 95% confidence interval [CI] = 1.08–3.83), with 6-month rates of 23.8% and 49.4%. In an analysis adjusting for baseline characteristics, prior focal brain therapy in cohort B reduced risk of intracranial progression (HR = 0.49, 95% CI = 0.26–0.92). Overall survival at 12 months was 67% in cohort A and 59% in cohort B. Subsequent focal brain therapy was required in 72% of patients in cohort A.
The investigators concluded, “Nivolumab activity is limited in patients with untreated brain metastases from clear cell renal cell carcinoma. Brain imaging and focal therapy should be considered before immune checkpoint inhibitors in patients with metastatic clear cell renal cell carcinoma.”
Laurence Albiges, MD, PhD, of Gustave Roussy, Université Paris-Saclay, Villejuif, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Bristol-Myers Squibb. For full disclosures of the study authors, visit jco.ascopubs.org.
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