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Adjuvant Atezolizumab in High-Risk Postresection Renal Cell Carcinoma

Compared with placebo in the IMmotion010 trial, adjuvant atezolizumab did not improve clinical outcomes after resection of renal cell carcinoma in patients with an increased risk of recurrence. “These study results do not support adjuvant atezolizumab for treatment of renal cell carcinoma,” the investigators conclude.

The randomized, double-blind, multicenter, phase 3 trial included adult patients in 28 countries who had renal cell carcinoma with a clear cell or sarcomatoid component and increased risk of recurrence. Participants were randomized to intravenous atezolizumab 1200 mg or placebo once every 3 weeks for 16 cycles or 1 year.

Based on a primary endpoint of investigator-assessed disease-free survival in the intention-to-treat population, the investigators found: “At data cutoff (May 3, 2022), the median follow-up duration was 44.7 months (IQR 39.1–51.0). Median investigator-assessed disease-free survival was 57.2 months (95% CI 44·6 to not evaluable) with atezolizumab and 49.5 months (47.4 to not evaluable) with placebo (hazard ratio 0.93, 95% CI 0.75–1.15, P = 0.50). The most common grade 3–4 adverse events were hypertension (seven [2%] patients who received atezolizumab vs 15 [4%] patients who received placebo), hyperglycaemia (ten [3%] vs six [2%]), and diarrhoea (two [1%] vs seven [2%]). 69 (18%) patients who received atezolizumab and 46 (12%) patients who received placebo had a serious adverse event. There were no treatment-related deaths.”

Source: Lancet