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By Earle Burgess, MD

When a patient with advanced bladder cancer comes to Levine Cancer Institute (LCI), we know they might be running out of options – and time. Most patients with pre-treated, metastatic disease only survive for around six months. We’re working to turn the tide, by leading one of the Southeast’s most comprehensive research programs and offering clinical trials of the most promising new agents – including the first personalized therapies for advanced bladder cancer and a novel targeted agent trial that isn’t currently available anywhere else.

Targeted Urothelial Cancer Treatment

Personalized, molecular approaches are revolutionizing treatment for certain breast and lung cancers, but progress against advanced bladder cancer has been slow – until now. We’re participating in a Phase III trial of the drug erdafitinib, which targets fibroblast growth receptors (FGFRs) that may help tumors develop and grow.

This drug earned the FDA’s Breakthrough Therapy Designation after a Phase II trial showed a 42 percent response rate among patients who had relapsed/refractory metastatic urothelial cancer and actionable FGFR mutations.

LCI is one of the highest accrual sites for the Phase II study and, so far, over 20 percent of potential participants have had actionable FGFR mutations. We’re hopeful that erdafitinib will extend survival and pave the way toward a new generation of personalized bladder cancer therapies.

Novel Molecularly Targeted Therapy for Metastatic Urothelial Cancer

We’re leading an investigator-initiated, Phase II study of crizotinib – a targeted therapy agent that inhibits the c-Met and RON receptors, among others. Our idea for this trial came when Phase III trials showed that crizotinib significantly extended survival for non-small cell lung cancer. We know that c-Met and RON are overexpressed in many advanced bladder cancer patients, and we use screening tests to look for these proteins in patients with metastatic urothelial cancer who have failed prior therapy.

So far, we’ve found elevated levels of these proteins in about half of potential participants. This makes them good candidates for the trial, and we think there’s a realistic chance that crizotinib can help in a similar way it did for lung cancer. This trial is currently only available at LCI.

Is Combination Therapy Effective?

If a patient isn’t eligible for the first two trials, we offer another option: a Phase I trial that combines the drug enfortumab vedotin with an immune checkpoint inhibitor.

Enfortumab vedotin is an antibody conjugate that recently received a Breakthrough Therapy Designation for patients with locally advanced or metastatic urothelial cancer who have received prior therapy. The current trial combines this agent with immunotherapy and aims to pinpoint side effects, and to investigate whether the combination therapy causes tumors to shrink.

Matching Patients with the Right Trial

These trials are only part of our push to pursue novel therapies for advanced bladder cancer and match patients with the most promising new agents. Our approach includes a weekly tumor board that brings more than 15 genitourinary cancer specialists together, including medical oncologists, radiation oncologists, surgical oncologists and pathologists. This enables us to evaluate patients from every angle, share ideas and develop a plan that matches patients with the right treatments and clinical trials – giving them the best chance for a good outcome.

Contact Us

For more information, or to make a referral, call 980-442-6186.