Updated 18-Month DOR of 80.6% from Ph 3 ENVISION Trial of UGN-102 Announced

“2024 was a pivotal year for UroGen with achievements across our commercial business and pipeline,” said Liz Barrett, President and Chief Executive Officer of UroGen. “The progress with UGN-102 for low-grade intermediate-risk non-muscle invasive bladder cancer, including completion of the submission of our NDA ahead of schedule and compelling DOR data from the Phase 3 ENVISION trial, further positions us to launch a product that we believe will represent a paradigm shift in care, if approved. UGN-102 is supported by a compelling body of clinical data, and we are very pleased to report today the 18-month DOR of 80.6% from the ENVISION trial, maintaining duration of response consistent with 12-month DOR of 82.5% after a three-month CR was achieved. If approved, UGN-102 will address an estimated market opportunity of over $5 billion. We continue to advance our early-stage pipeline, including through the recent purchase of ICVB-1042, a next generation investigational oncolytic virus therapy with potential applications in bladder and other cancers.”
Share:
More News
PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is