UroGen Pharma, based in New York, announced positive topline results from its Phase III OLYMPUS clinical trial. The trial evaluated UGN-101 (mitomycin gel) for installation for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC). Of the 71 patients in the trial, 61 have been evaluated for the primary endpoint, which was a complete response. The remaining 10 patients are awaiting primary disease evaluation (PDE). On an intent-to-treat basis, 57 percent of patients showed a CR at their PDE. The PDE was conducted four to six weeks after completing treatment with UGN-101. About 45 percent of the cancers were categorized as unresectable by surgery at baseline. Of the patients who hit CR, six-month durability has been determined on about half. Durability is a key secondary endpoint.
“We are pleased to report that the CR and durability data remain consistent with the Interim Analysis presented in May 2018,” stated Mark P. Schoenberg, UroGen’s chief medical officer. “These results continue to validate the potential of UGN-101 to shift the surgical treatment paradigm and benefit patients whose only alternative would be repetitive endoscopic surgical intervention or complete loss of a kidney.” Schoenberg added, “The durability observed in the OLYMPUS study provides further evidence that the non-surgical treatment of LG UTUC with UGN-101 may result in clinically-meaningful, recurrence-free survival. We are grateful to the patients, their families, and clinical investigators who have made this important study possible.”