NeoGenomics announces results from study of RaDaR assay

NeoGenomics announced results of a new study of the RaDaR assay in patients with muscle-invasive bladder cancer immediately following treatment with a combination of the immune checkpoint inhibitors in the neoadjuvant setting. Plasma and urine collected from the patients during treatment was analyzed. The RaDaR assay is a personalized, highly-sensitive sequencing test for the detection of minimal residual disease and recurrence. MRD is the trace amounts of circulating tumor DNA that remain after surgery or other cancer treatment. The study, published in the journal Nature Medicine, found that the absence of ctDNA in plasma – as detected by RaDaR – was associated with patient responses to treatment prior to surgery offering the possibility of avoiding aggressive surgery that removes the patient’s bladder. The new data are part of the second cohort of the Phase 1b/2a NABUCCO trial, which investigated patient responses to neoadjuvant treatment with a CTLA-4 inhibitor in combination with a PDL1 inhibitor among patients with locoregionally-advanced urothelial cancer. In both cohorts, RaDaR assay was used before and during neoadjuvant therapy as well as pre-surgery to assessed ctDNA in urine and blood plasma to determine patient response to treatment. Cohort 1 helped establish the feasibility of neoadjuvant therapy with ipilimumab 3 mg/kg plus nivolumab 1 mg/kg, demonstrating high pCR rates. In Cohort 2, patients received either ipilimumab 3 mg/kg plus nivolumab 1 mg/kg or ipilimumab 1 mg/kg plus nivolumab 3 mg/kg, both for two cycles, followed by nivolumab 3 mg/kg. Overall, 43 percent in cohort 2A and 7 percent in cohort 2B achieved a complete pathological response, the primary endpoint. The absence of ctDNA in blood plasma was highly associated with both pCR and PFS. In urine, the absence of ctDNA was linked to pCR but not PFS.