UroGen Pharma shows positive results for bladder cancer patients
pharmafile | October 6, 2021 | News story | Research and Development |
UroGen Pharma Ltd has published results from the Phase IIb OPTIMA II trial, a single-arm trial studying UGN-102 (mitomycin) as a treatment for low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC).
The results of the study will be in the January print edition of The Journal of Urology.
UroGen is a biopharmaceutical company, focused on creating novel solutions that treat specialty cancers and urologic diseases. The results from the recent study showed a significant treatment response with sustained durability in non-surgical chemoablation of LG IR-NMIBC. 65% of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy, of whom 95%, 73%, and 61% remained disease-free at 6, 9, and 12 months after treatment initiation, respectively.
Treatment with UGN-102 was generally well tolerated, and the safety profile was consistent with previously reported results.
These results are promising as these patients are chronically relapsing. There is also currently very limited treatment as their only treatment option is repeated transurethral resection of bladder tumour (TURBT), with or without chemotherapy, and some patients require multiple TURBT surgeries per year, which can actually lead to post-operative and long-term morbidity.
“The data from the OPTIMA II trial represent a significant advancement in the development of UGN-102 for the treatment of LG IR-NMIBC and further support the contention that non-surgical therapy for this disease is both technically feasible and clinically meaningful,” commented Dr Mark Schoenberg, Chief Medical Officer at UroGen.
“With UGN-102, our goal is to change the treatment paradigm in LG IR-NMIBC by enabling non-surgical chemoablation. These results provide an important validation of our approach to treating low-grade disease, and our rationale for the continued evaluation of UGN-102 in the ongoing Phase 3 ATLAS study.”
Lina Adams
