Interim results from a phase 3 trial showed that certain patients with urinary system cancer treated with UroGen Pharma Ltd.'s investigational drug MitoGel, or UGN-101, had no detectable signs of cancer after treatment.
The trial, named Olympus, evaluated the drug for the nonsurgical treatment of low-grade upper tract urothelial cancer. Upper tract urothelial cancer is a malignancy involving the lining of the ureters, renal pelvis and kidneys.
An interim analysis from the international, multicenter trial showed a complete response rate of 59% in 34 patients who were evaluated for primary disease evaluation, conducted four to six weeks after completion of UGN-101 treatment, which was administered once weekly for six weeks.
Complete response, also known as complete remission, does not necessarily mean the cancer has been cured.
In addition, five of 34 patients, or 15%, saw a reduction in their tumors after treatment.
Of the 20 patients who achieved a complete response, 13 patients have reached three-month follow-up and all remain in complete response. Four of these 13 patients have reached six-month follow-up and one of the 13 patients has reached nine-month follow-up. All remain in complete response.
UroGen Pharma expects top-line result from the trial, which continues to enroll patients, in the second half of 2018.