AACR: Intralesional Nivolumab Reduces Size of Precancerous Oral Lesions

THURSDAY, April 23, 2026 (HealthDay News) -- Intralesional nivolumab seems effective for reducing the size of precancerous oral lesions, according to a study presented at the annual meeting of the American Association for Cancer Research, held from April 17 to 22 in San Diego.Moran Amit, M.D., Ph.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues conducted a phase 1, open-label, dose-escalation trial of intralesional nivolumab in patients with histologically confirmed oral epithelial dysplasia. Twenty-nine patients received four cycles of 10 or 20 mg intralesional nivolumab every three weeks.The researchers did not observe any dose-limiting toxicities; 94 percent of adverse events were grade 1 to 2, and no systemic immune-related toxicities were seen. Plasma nivolumab concentrations remained 10-fold below intravenous dosing, with no evidence of accumulation. Across cohorts, there was a 60 percent decrease in lesion area, with 41 percent histologic downgrading. Twelve-month cancer-free survival was 75.8 percent; progression events were all detected early and could be salvaged by surgery. Despite significant travel burden, high study completion (86 percent) and adherence were seen, coupled with stable or improved quality-of-life scores. Patient quality of life was preserved with this strategy. Immune activation was seen exclusively in treated lesions, with increased CD4+ and CD8+ T-cell infiltration, enriched CCR7+ activated dendritic cells, elevated CD103+ tissue-resident CD8+ T-cells, and formation of higher-order immune assemblies. No immune changes were seen in untreated nonindex lesions from the same patients."Our findings demonstrate that intralesional delivery of nivolumab is safe, well tolerated, and results in efficacy rates unparalleled by other nonsurgical methods, which allowed us to spare surgery for the majority of patients," Amit said in a statement.Press ReleaseMore Information.Sign up for our weekly HealthDay newsletter

AACR: Intralesional Nivolumab Reduces Size of Precancerous Oral Lesions

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