Bladder Cancer

The initial results from JAVELIN Bladder 100 supported the FDA approval of avelumab for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.

Vignesh Packiam, MD, discusses study results showing sequential intravesical gemcitabine and docetaxel is an effective and well-tolerated therapy for BCG-naïve NMIBC.

Vignesh Packiam, MD, explains how innovation driven by the BCG shortage led to a potential promising new regimen of sequential intravesical gemcitabine and docetaxel for patients with BCG-naïve non–muscle-invasive bladder cancer.

“Several of these patients were able to undergo surgery that spared them the need to remove their ureter and their kidney,” says Matthew T. Campbell, MD.

“The NRG SWOG 1806 trial is a phase 3 trial randomizing patients to standard trimodality therapy or trimodality therapy plus atezolizumab,” says Sophia Kamran, MD.

“We call it ‘trimodality therapy,’ because it involves the 3 main disciplines: surgery, radiation oncology, and medical oncology,” says Kamran.

Pramit Khetrapal, MD, discusses the abstract, “Results of the intracorporeal robotic vs open cystectomy multi-centre randomised trial,” which he presented at the 2022 AUA Annual Meeting.

“The open operation is obviously done using a single incision that is quite big,” says Khetrapal.

“UGN-102 may offer a patient-centered therapeutic approach, more patient centered than standard treatments like surgery,” says Angela M. Stover, PhD.

The application is supported by findings from the phase 2/3 QUILT-3.032 trial.

“What we did find is that UGN-102 did not cause decrements in patient-reported urinary symptoms, bloating, flatulence, or malaise at the primary trial end point of 3 months,” says Angela M. Stover, PhD.

Study results presented at the 2022 AUA Annual Meeting showed that pembrolizumab plus cabazitaxel and gemcitabine had promising early efficacy in heavily pretreated patients with high-risk non–muscle invasive urothelial carcinoma.

The combination induced a response in nearly two-thirds of patients with unresectable locally advanced or metastatic urothelial cancer when used in the frontline setting.

“Histologic variants do express Nectin-4 and Trop-2, the targets of antibody-drug conjugates that are FDA-approved in bladder cancer,” says Fed Ghali, MD.

Fed Ghali, MD, discusses the outlook for patients with variant histology bladder cancer and how antibody-drug conjugates may provide a new treatment option in this setting.

FDA talks have led to a voluntary pause on the development of Vicineum for bladder cancer in the United States.

"I think that for patients that have high-risk features after cystectomy, they absolutely should be on nivolumab. I don't think that's a controversial statement anymore," says Benjamin J. Davies, MD.

The analysis showed promising signs of clinical activity with cabazitaxel/gemcitabine plus pembrolizumab in patients with docetaxel-unresponsive non-muscle invasive urothelial carcinoma of the upper and lower urinary tracts.

In this interview, Sanjay Patel, MD, discusses blue light cystoscopy for the detection of bladder cancer.

“There are numerous trials that say that if you use blue light cystoscopy, in about 25% of patients, it will help you pick up a tumor you otherwise would have missed with traditional white light cystoscopy,” says Sanjay Patel, MD.

The approval is based on the randomized, double-blind phase 3 CheckMate -274 trial, which previously supported FDA approval of the immunotherapy in this setting.

Belzupacap sarotalocan is a virus-like drug conjugate that consists of a virus-like particle conjugated with an anticancer agent.

“To have at the 2-year mark basically half the patients still without evidence of disease is really a step forward,” says Sam S. Chang, MD, MBA.

“What’s really exciting over the next few years is how are these antibody-drug conjugates that are already FDA-approved going to partner with other current drugs that we can use to treat this disease, such as immunotherapy,” says Garmezy.

"A key overarching question is whether there is just a higher burden/stage of disease “beyond which we don’t think a bladder preservation is likely to provide durable disease control,” says Neil Desai, MD.