UroGen Pharma Ltd.'s bladder cancer drug UGN-101 helped 59% of patients achieve remission after 12 weeks of treatment, meeting the main goal of a late-stage clinical trial.
The study, dubbed Olympus, evaluated UroGen's mitomycin gel in 71 patients with low-grade upper tract urothelial cancer. This type of cancer is relatively rare, affecting the renal pelvis and tubes that carry urine from the kidneys to the bladder. The tumors often reoccur in new places within the urinary tract.
UroGen's UGN-101 is a gel formulation of mitomycin that is administered over time to allow for longer exposure of the urinary tract to the medicine. The gel is administered via catheter, allowing for nonsurgical treatment.
Results from the Olympus study showed that 42 patients had no sign of cancer after 12 weeks, also called a complete response. After six months, 89% of patients remained in remission, and 84% of patients remained cancer-free at one year. The median time for the cancer to reoccur was estimated to be 13 months.
At the start of the study, 34 of the patients had a tumor that could not be removed via surgery, and 59% achieved complete response after the treatment. Remission was maintained similarly to the larger group in the trial.
Side effects were observed in 48 patients, with 37 requiring surgical intervention including permanent or temporary placement of a ureteral stent. One patient experienced a brain bleed called a subdural hematoma. More common effects included urinary tract infection, kidney impairment, blood in the urine and a narrowing of the tube that carries urine from the kidney to the bladder.
UroGen also reported results from Optima II, a phase 2b trial of UGN-102 mitomycin gel, which studied 62 patients with an intermediate risk of low-grade non-muscle invasive bladder cancer recurrence. This type of cancer is found in the inner layer cells of the bladder and does not invade the muscular wall. The interim results showed 20 patients achieving remission. The New York-based company intends to initiate a phase 3 trial in 2020 following discussion with the U.S. Food and Drug Administration.
The company initiated its rolling FDA submission of a new drug application for UGN-101 in December 2018. The U.S regulator has granted UGN-101 orphan-drug, fast-track and breakthrough-therapy designations.
