Sarah Psutka, MD, on the Cretostimogene Grenadenorepvec Expanded Access Program

In this video, Sarah P. Psutka, MD, MSc, highlights the design and rationale for the study, “The Cretostimogene Grenadenorepvec Expanded Access Program in Patients with Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin,” which was shared during the Society of Urologic Oncology 25th Annual Meeting in Dallas, Texas. Psutka is an associate professor of urology at the University of Washington and Fred Hutchinson Cancer Center

Video Transcript:

Cretostimogene is an oncolytic adenovirus that currently has a breakthrough indication and fast track application under review for the indication of BCG-unresponsive non-muscle-invasive bladder cancer, so high-risk bladder cancer. Here at the meeting, Mark Tyson will be presenting the topline results of the BOND-003 trial, which are the data that establishes the efficacy and the safety. There's a 74% complete response rate with this intravesical therapy, which is very exciting and encouraging. I think even more interesting and more exciting is the median duration of response has not been reached, but it's at least 27 months, which is a very extended duration of response among those patients who achieve a CR. Then, the safety data is very promising, with no patients experiencing a grade 3 AE.

You have a therapy that['s] a novel biologic therapy that has a very interesting and different mechanism in a space that has activity in a very at-risk cohort of patients that is going through the regulatory approval process. The company I believe is anticipating, over the next 2 years, completing that process. But what's a key issue, if you look at what we were talking about in terms of generalizability of data, the BOND-003 cohort was very reflective of what we see in most clinical trial cohorts for patients with bladder cancer: overwhelmingly Caucasian [and] overwhelmingly male. And obviously there are strict eligibility criteria for those trials, so you end up seeing efficacy data and safety data in a cohort that doesn't necessarily generalize to the greater population. With the Expanded Access Program, it is an opportunity for patients to receive the drug in real-world practice.

The company is working to recruit sites that are likely to have a fairly diverse patient population—academic centers, but also very strongly targeting community practices and even VAs—with the goal of being able to offer patients who might not be able to access FDA approved treatments in this disease space and give them a drug that has good oncologic efficacy and a great safety profile and a good tolerability profile. And then prospectively collect the data now that will help inform treatment decision-making and shared decision-making in the future.

The other nice part of the data collection plan—so the trial is both patient-friendly and physician- or investigator-friendly. There are also important data points that are being collected that I think are going to be very helpful in thinking about how to make decisions around cretostimogene use in the future, because they are prospectively collecting quality-of-life and PRO data as well. At the end of the day, when we start trying to figure out and unpack the treatment selection question with the data that's largely coming from non-comparative trials, that patient reported data, I think is going to be really important.

This transcript was AI generated and edited by human editors for clarity.