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GU Cancers 2018 | A bladder-sparing approach for muscle-invasive bladder cancer

From the 2018 Genitourinary Cancers Symposium, held in San Francisco, CA, Elizabeth Plimack, MD, from Fox Chase Cancer Center, Philadelphia, PA, introduces the key trials in progress at her center, including a treatment allocation study for patients with muscle-invasive localized bladder cancer, which features a combination of cystoscopy and tumour genomics to reduce the number of patients undergoing cystectomy. In addition, Dr Plimack also highlights a trial testing the combination of nivolumab and axitinib for kidney cancer (NCT03172754). Finally, she discusses a study looking to sensitize bladder cancer patients that are refractory to PD-1 inhibiton using guadecitabine (NCT03179943).

Transcript (edited for clarity)

We have a couple of really exciting trials open at Fox Chase right now, and they’re open, we don’t have results from them but we have really good science to sort of back up the strategy that we’re doing and I’ll talk about three of them.
The first one is a treatment allocation study for people with muscle invasive localized bladder cancer, these are patients who would normally get neoadjuvant chemotherapy followed by surgery to remove their bladder...

We have a couple of really exciting trials open at Fox Chase right now, and they’re open, we don’t have results from them but we have really good science to sort of back up the strategy that we’re doing and I’ll talk about three of them.
The first one is a treatment allocation study for people with muscle invasive localized bladder cancer, these are patients who would normally get neoadjuvant chemotherapy followed by surgery to remove their bladder. We think that, by using a combination approach of imaging, cystoscopic evaluation of the inside of the bladder, and genomics on the tumor, we can predict which patients are going to achieve a complete response to this neoadjuvant chemotherapy, and then as per this trial, those patients are allowed to keep their bladder in place and go on to surveillance. And we’re hoping that with this approach, we’ll be able to spare a subgroup of patients, we think, hopefully twenty to thirty percent of patients from cystectomy, so that they can live with their bladders intact. So that one is open and accruing briskly, we’re going to be opening in a couple other centers in the US as well, that’s one we’re very excited about.
We have another trial in kidney cancer looking at the combination of nivolumab with axitinib, another VEGF/PD1 combination. Axitinib we think, combines very well. It’s combined safely with a nivolumab, it’s combined safely with pembrolizumab as we just discussed, we’re looking at it in combination with nivolumab. And that study once we prove safety, which should be complete in a few months, then we’ll expand to a front line and a second line cohort, and that will be open in New York, in Baltimore, and in Fox Chase in Philadelphia shortly, so we’re very excited about that.
And the third study I’ll talk about is also a bladder study, and this is a study looking to see if we can take those patients refractory to PD1 inhibition, and make them sensitive to PD1 inhibition. The science behind this is very well developed and very robust, but our approach is to take patients who have progressed on a checkpoint inhibitor, pembrolizumab or atezolizumab for instance, and then give them atezolizumab, but add a drug called guadecitabine, which is a hypomethylating agent. There’s very good data that this hypomethylating agent increases expression of antigen, improves antigen presentation and overall, uses this viral mimicry mechanism to create a very immune-sensitive microenvironment in the tumor.
So that’s funded, we were very excited by a stand up to cancer Genentech catalyst award through the AACR, and so we’re excited to have that up and running and rolling.

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