UroGen’s urothelial cancer drug hits target, could prevent surgery

Just days after the company confirmed it had hired Barrett as CEO, UroGen announced that the phase 3 OLYMPUS trial showed that more than half of patients treated with UGN-101 with low grade upper tract urothelial cancer were disease free after six months.

UGN-101 is a gel formulation of the chemotherapy mitomycin allowing for prolonged exposure of the active ingredient, which the company says could be an alternative for patients whose only other treatment option would be repetitive surgical intervention or the complete loss of a kidney.

The data from the trial shows a complete response rate of 57% in patients, and all those in complete response were disease-free at six months.

UroGen last month began a rolling review of the drug with the FDA, which is due to be completed later this year.

OLYMPUS is an international multi-centre trial with 71 patients having completed enrolment in December. Of the patients enrolled in the trial, 61 patients have been evaluated for the primary endpoint of  complete response, defined as a negative ureteroscopic evaluation and a negative wash cytology.

The remaining 10 patients are awaiting evaluation. Approximately 45% of tumours treated were categorised as unresectable by surgery at baseline. Of the patients who achieved CR, UroGen now has six-month data showing a durable response in half of these patients. Durability is a key secondary endpoint for the trial.

UroGen said the safety profile of UGN-101 continues to be "acceptable" with most treatment-emergent adverse events characterised as mild or moderate and transient and in line with ureteral procedures.

These included ureteral narrowing and hydronephrosis, urinary tract infection, flank pain and creatinine elevation.

Mark Schoenberg, chief medical officer of Urogen, said: "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."

Barrett raised eyebrows last month after she stepped down from her role as CEO of Novartis’ oncology unit after less than a year, to become CEO of an unnamed US biotech, saying she did not want to relocate to Switzerland.

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