UroGen bladder cancer treatment excels in late-stage trial

UroGen Pharma, a New Jersey-based company, has revealed "unprecedented" 12-month response duration data from a phase 3 clinical trial for its innovative mitomycin formulation, UGN-102, aimed at treating non-muscle invasive bladder cancer (NMIBC). The ENVISION study showcased UGN-102's efficacy with a 79.6% complete response rate at three months and an 82.3% response duration at 12 months. These promising results highlight UGN-102's potential to become the first FDA-approved nonsurgical treatment for low-grade, intermediate-risk NMIBC.

UGN-102 is administered through a urinary catheter in an outpatient setting, allowing for prolonged exposure of bladder tissue to mitomycin. This extended exposure facilitates tumor treatment without the need for surgery, leveraging UroGen's proprietary RTGel technology, which is a sustained-release hydrogel-based formulation.

The recurrent nature of low-grade, intermediate-risk NMIBC typically necessitates multiple surgeries over a patient's lifetime. If approved, UGN-102 could offer a minimally invasive alternative, significantly reducing the need for surgical interventions. In January 2024, UroGen began submitting a rolling New Drug Application (NDA) to the FDA for UGN-102, with the latest data supporting this application. The company anticipates a potential FDA decision by the first quarter of 2025.

There have also been notable advancements in treatments for higher-risk NMIBC. In April, the FDA approved ImmunityBio's Anktiva, an IL-15 receptor agonist immunotherapy, for patients with high-grade, BCG-unresponsive non-invasive bladder cancer. Additionally, in 2022, Ferring Pharmaceuticals secured the first gene therapy approval for bladder cancer with its adenovirus vector-based therapy, Adstiladrin. Adstiladrin was also approved for the treatment of high-risk, BCG-unresponsive NMIBC.

These developments underscore significant progress in the field of bladder cancer treatment, offering new hope and potentially less invasive options for patients across different risk categories of NMIBC.