A Phase III, Single-Arm Study to Evaluate the Efficacy and Safety of Paclitaxel-Hyaluronic Acid Conjugate Administered Intravesically to Patients with BCG-Unresponsive Carcinoma in Situ of the Bladder With or Without Ta-T1 Papillary Disease (Orion-BC Study)
Sunil Patel, M.D.
It's my pleasure to present some of the work that we've been a part of in this very large clinical trial. Um This is a phase two, excuse me, phase three, single arm multi center International study to assess the efficacy and safety of onco PB, which is paclitaxel highly runic acid conjugate followed uh following intravesical insulations in adult patients. And this is uh a study really that we're presenting at the A U A Insane and um at the National Conference and to really help uh kind of promote this study and really kind of talk about what it is all about. So this study is uh like I said, it's an international study, but it's really, really focusing on patients who have uh cis um bladder anonymous ova and bladder cancer with or without T A or T one disease who've been unresponsive to prior BC G therapy and are unwilling or unfit to undergo a radical cystectomy. And this study is really important like other studies in this space for patients who have recurrent non muslim invasive bladder cancer. After BC G BC G has been the standard of care for non muscle invasive bladder cancer for many years. However, there are a subset of patients who recur or progress on BC G also in the, in this modern era, which we're seeing more often than not. Are there are a lot of international national shortages of BC G which are really constricting uh pro providers and patients on options on what to do when they do occur um after having ABC G therapy. And so this clinical trial is really providing a different drug and a different application to this drug to really see what, how it can fit in this anomalous avasive bladder cancer space. And so this clinical trial which is ongoing is really uh for patients uh like I said, who had failed BC G with CIS, and they would get an additional induction therapy of this drug, which consists of 12 weekly installations uh of the drug which is on PB um which is considered the induction phase. Then the patients would be re evaluated with cystoscopy and cytology and those patients who have a complete response will undergo maintenance therapy, which is monthly treatments for an additional 12 months or until recurrence. Um And the overall uh uh primary end point is a complete response rate. However, there are numerous secondary uh uh end points of this study and to really look at the complete response rate. Uh but really at a different time point such as 69, 18 and 24 months after the treatment, really looking at the duration of response, the um and again, different time points for the duration, the progression rate, uh time to progression um and patients uh undergoing cystectomy due to progression uh event, free survival, overall survival. And the really looking at the uh treatment related adverse events um as well. So this study like other studies is really geared and really focused to help out clinicians as well as patients to provide another drug, This much needed space for patients who have recurrence or progression of their disease in the non muscle, basic bladder cancer space and providing them another option prior to removal of the bladder. So we're really looking forward to accruing more patients and really uh seeing the results of this study in the coming months.
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