UroGen nonsurgical bladder cancer treatment excels in late-stage trial

2024-06-14

临床3期免疫疗法临床结果上市批准申请上市

New Jersey-based UroGen Pharma has shared "unprecedented" 12-month duration of response data from a phase 3 trial for UGN-102, an innovative formulation of mitomycin, in non-muscle invasive bladder cancer (NMIBC).

In the ENVISION study, UGN-102 demonstrated a 79.6% three-month complete response rate and 82.3% duration of response at 12 months — reinforcing the company's lead candidate's potential to be the first FDA-approved nonsurgical option for treatment of low-grade intermediate-risk NMIBC.

UGN-102, delivered to patients using a urinary catheter in an outpatient setting, is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by nonsurgical means. The treatment utilizes UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation.

Low-grade intermediate-risk NMIBC's highly recurrent nature often means patients must undergo numerous surgeries throughout their lifetime, so UGN-102, if approved, could provide a minimally invasive option.

In January 2024, UroGen initiated the submission of a rolling NDA to the FDA for UGN-102 and this latest data will support that application. UroGen says a potential FDA decision could come as early as the first quarter of 2025.

Recent progress has been made for higher risk forms of NMIBC as well. In April, the FDA has approved ImmunityBio's Anktiva, an IL-15 receptor agonist immunotherapy, for patients with a high-grade form of non-invasive bladder cancer, known as BCG-unresponsive. In 2022, Ferring Pharmaceuticals won the first gene therapy approval for bladder cancer for its novel adenovirus vector-based therapy, Adstiladrin. Adstiladrin was also approved for the treatment of high-risk, BCG-unresponsive NMIBC.

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