Bladder Cancer

The approval was primarily supported by data from the phase 3 EV-301 trial, in which enfortumab vedotin reduced the risk of death by 30% versus chemotherapy in patients with heavily pretreated locally advanced or metastatic urothelial carcinoma.

“What was very impressive from the study was by sequentially using Cxbladder Triage, Detect, and Resolve, we could not only segregate those who had cancer versus not, but also those who had low-risk tumors versus high-risk tumors,” says Jay Raman, MD, FACS.

“The purpose of [Cxbladder] Resolve is to identify not only those patients who are at higher risk for urothelial or urinary tract cancer, but those that have a high probability of an aggressive cancer, such as high-grade TA, carcinoma in situ, or T1 to T3,” says Jay Raman, MD, FACS.

The novel oncolytic immunotherapy CG0070 is also currently being explored as a in a phase 3 monotherapy trial.

Michael S. Cookson, MD, previews the 2021 AUA Annual Meeting, with a focus on prostate, bladder, and kidney cancer. His in-depth analysis covers the plenary sessions, late-breaking abstracts, and other abstracts of interest.

Over half of patients had pathologic downstaging after receiving the neoadjuvant regimen.

The FDA has converted the accelerated approval of frontline pembrolizumab in advanced bladder cancer to a full approval and revised the indication to cover the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy.

Urologists and medical oncologists should collaborate to tailor therapy to the specific needs of the patient.

Nonsurgical primary chemoablation with the mitomycin-containing reverse thermal gel UGN-102 showed promise as an alternative to repetitive surgery for patients with low-grade non–muscle invasive bladder cancer.

In a news release, Checkmate -274 primary investigator Matthew Galsky, MD, hailed the approval as a “major milestone for patients who have undergone major surgery to remove the bladder or parts of the urinary tract and are in need of additional treatment approaches that can help reduce the risk of their UC returning."

Ventana MMR RxDx Panel is a qualitative immunohistochemistry test that assesses a panel of MMR proteins to help guide clinicians in their treatment decisions.

Thomas Powles, MBBS, MRCP, MD, discusses where enfortumab vedotin fits in the bladder cancer treatment paradigm.

The FDA has issued a complete response letter to Sesen Bio regarding its biologics license application for Vicineum (oportuzumab monatox-qqrs) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer.

The published data are from the pivotal CheckMate 274 trial and are currently being reviewed by the FDA for a potential approval of nivolumab in this setting.

Arjun V. Balar, MD, discusses notable findings from 2 separate studies of pembrolizumab (Keytruda).

The survival benefit in patients with PD-L1–negative tumors mirrored the benefit in the overall study population.

The ADXBLADDER urinary biomarker test is being explored as a tool to assist in the monitoring of cancer recurrence in patients with non-muscle invasive bladder cancer.

Thomas Powles, MBBS, MRCP, MD, director, Barts Cancer Institute, discusses findings from the pivotal EV-301 trial of enfortumab vedotin.

This installment of Around the Practice focused on the multidisciplinary approach to bladder cancer care.

The noninvasive UriFind test identifies bladder cancer based on methylation detection of exfoliated cell DNA in urine.

“The key message from this abstract is that the time duration for starting avelumab [Bavencio] maintenance didn't really affect the outcomes,” says Shilpa Gupta, MD.

Singh highlights the phase 3 INTACT trial, which is comparing the safety and efficacy of standard chemoradiation alone versus chemoradiation plus atezolizumab in patients who received TURBT.

Shilpa Gupta, MD, discusses several recent studies in the metastatic urothelial carcinoma space.

Yousef Zakharia, MD, discusses the design and results of a phase 2 trial that explored concurrent treatment with radiation and the PD-L1 inhibitor durvalumab followed by adjuvant durvalumab in patients with urothelial cancer.

Risa Wong, MD, discusses the sequencing of treatments in the metastatic urothelial carcinoma armamentarium, including chemotherapy, immune checkpoint inhibitors, and antibody-drug conjugates.

"I think [at] the 2021 ASCO annual meeting, we saw a lot of novel data focusing on bladder-preservation approaches," says Shilpa Gupta, MD.

Investigators report that high urinary cotinine levels are associated with a greater risk of recurrence in smokers.

The approval is based on findings from the EV-301 and EV-201 trials.

Dr. Michael Devitt, discusses whether circulating tumors cells are ready for primetime as a diagnostic/prognostic biomarker in urothelial carcinoma.

Recent trial demonstrates an improvement in outcomes with an adjuvant immune checkpoint inhibitor in urothelial cancer.