Of the 40 patients who responded to therapy, 14 remained free of high-grade tumor recurrence a year after treatment began, with similar findings in both dosage arms, as well as between those with refractory and relapsed non-muscle invasive bladder cancer.
Twelve-month recurrence-free survival for patients with papillary (Ta/T1) only disease was 50%.
The most common adverse events were micturition urgency, dysuria and pollakiuria, fatigue, and nocturia.
“There is now an open and enrolling phase III clinical trial of this agent that is being done nationally, across multiple centers in the U.S.,” Dr. Boorjian said. “If these results are maintained in the phase III study, this therapy has the potential to represent a significant advance for patients as an option to treat high-grade non-muscle invasive disease after BCG. Right now, the alternative is radical cystectomy, which does carry with it morbidity. So, this is an option for patients, who are often elderly, with other comorbidities, to avoid having to undergo cystectomy.”
Study co-author Neal D. Shore, MD, said the phase II trial’s results are significant for this patient population.
“In this phase II trial, we saw excellent tolerability and, more importantly, very significant efficacy of a novel intravesical therapy with a unique mechanism of action, which achieved a 35% complete response rate at 1 year in a previously BCG treated, high-risk bladder cancer population,” said Dr. Shore, of Carolina Urologic Research Center, Myrtle Beach, SC. “We look forward to the phase III trial, which will hopefully confirm the results in the presentation by Dr. Boorjian and, thus, lead to a significant therapeutic advance for BCG unresponsive disease.”
Dr. Boorjian has consulting and advisory roles with Astellas Pharma and Medivation. Dr. Shore has consulting or advisory roles with Astellas, Bayer, Dendreon, Ferring, Janssen, Medivation, Sanofi, and Tolmar. Several of their co-authors have a financial or other relationship with pharmaceutical companies. In addition, several of their co-authors’ institutions have received research funding from Bristol-Myers Squibb and/or other pharmaceutical companies.
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