So in stage one testicular cancer, we know this is highly curable. The current standard of care would be active surveillance, but some patients do undergo adjuvant chemotherapy, those patients with the highest risk of recurrence. The problem is even in those with the highest risk of recurrence, the use of adjuvant chemotherapy leads to unnecessary treatment and toxicity in the majority of patients...
So in stage one testicular cancer, we know this is highly curable. The current standard of care would be active surveillance, but some patients do undergo adjuvant chemotherapy, those patients with the highest risk of recurrence. The problem is even in those with the highest risk of recurrence, the use of adjuvant chemotherapy leads to unnecessary treatment and toxicity in the majority of patients. So what we need are better biomarkers that can predict recurrence. And one of those biomarkers could be microRNA 371. So the clinical study went about understanding if microRNA 371 can predict recurrence. And so we enrolled 200 patients from Australia and New Zealand across 12 sites and we recruited them and they underwent active surveillance for stage one testicular cancer. They had blood tests looking for microRNA 371 at baseline and then every three months, for the first couple of years. And today we reported our interim analysis. So these interim results looked at whether a baseline microRNA 371 could predict recurrence. We looked at the positive and negative predictive value and also compared a plasma versus serum assay. And what we found in this interim analysis was that the plasma assay was superior to serum and that yes, in fact, a microRNA 371 at baseline just after orchiectomy can predict for recurrence with a hazard ratio of 10.3, p-value, highly significant, less than 0.001. What we found at 24 months was that the recurrence-free rate in those who were positive was 32%, but in those who were negative was 89%. So it clearly stratifies for recurrence. And so what we hope in the next step is can we design the studies that can demonstrate that those who are positive do need adjuvant chemotherapy.
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