Bladder Cancer

An exploratory analysis of the IMvigor130 study failed to show an improvement in overall survival with atezolizumab, compared with placebo plus platinum-based chemotherapy and gemcitabine in patients with untreated locally advanced or metastatic urothelial cancer.

Treatment with nivolumab in patients with high-risk muscle-invasive urothelial carcinoma continued to improve survival, supporting its use as a standard of following radical resection.

In cohort B of the phase 2 Keynote-057 trial, pembrolizumab led to antitumor activity in patients with BCG-unresponsive, papillary high-risk non–muscle-invasive bladder cancer.

The ORR for patients was 47%. Of note, ORRs were higher in patients with specific alterations compared with wild type including ERBB2 (67% vs. 44%, respectively; P = .05) and TSC1 (68% vs. 25%; P = .04).

In the the phase 2 HCRN GU 16-257 trial, 33 patients with muscle-invasive bladder cancer were eligible to forego cystectomy and continue 240-mg maintenance nivolumab monotherapy every 2 weeks for 8 cycles followed by surveillance.

"It's important to make sure that this is something that is desired by our patients before pursuing further," says Timothy D. Lyon, MD, FACS.

“A majority of patients that present with bladder cancer do not have muscle invasive disease. They have earlier stage, non-muscle invasive, and the NCCN guidelines have detailed guidance for providers about managing those patients,” said Thomas Flaig, MD.

Lerapolturev will be given via intravesicular instillation to adult patients with recurrent NMIBC intended for transurethral resection of bladder tumor (TURBT) or cystectomy.

"Over the past 10 to 15 years, tremendous efforts have gone into robotic surgical innovation to improve perioperative morbidity for patients with bladder cancer undergoing RC," write Andrew M. Wood, MD, and Nima Almassi, MD.

First-ever offering will help bladder cancer patients, caregivers and survivors cope with the disease.

Applicants may be working in basic, translational, clinical, epidemiologic, bioengineering sciences or any other field, but projects must be specific to bladder cancer and/or upper tract urothelial carcinoma.

BCAN’s Young Investigator Awards support outstanding early-career scientists and clinical cancer researchers with a demonstrated commitment to improving the understanding and treatment of bladder cancer and/or upper tract urothelial cancer.

"Patients with intermediate-risk NMIBC remain an incredibly heterogeneous group," says Wei Shen Tan, MD, PhD.

“I think really identifying who's going to benefit from what combination for how long is going to be important,” says Stephanie Berg, DO.

"Our new study is the first post-market analysis to see how doctors are using this drug in routine practice and what their patient outcomes are,” said Soloman Woldu, MD.

Several treatments are being explored across these trials, including pembrolizumab, nivolumab, enfortumab vedotin, durvalumab, avelumab, and cabozantinib.

Adding trilaciclib to platinum-based chemotherapy and maintenance avelumab yielded responses in patients with untreated, locally advanced or metastatic urothelial carcinoma.

Novel targeted therapy BT8009 granted FDA Fast Track Designation for urothelial cancer.

“Clinicians should do whatever they're able to try to limit or reduce the need for an intraoperative transfusion,” says Timothy D. Lyon, MD, FACS.

The acceptance allows investigators to proceed with the phase 1/2a study of the intraoperative immunotherapy SURGERx with resiquimod (STM-416).

“Each unit of blood that you got during surgery was associated with about 7% higher odds of a VTE within 90 days,” says Timothy D. Lyon, MD, FACS.

"I think NAI plus BCG will be a game-changer in the community, probably more than it would be in academic medical settings," says Karim Chamie, MD.

As the year comes to a close, we revisit some of this year’s top content on bladder cancer.

"The previous group who had looked at this saw a 15% adherence to the AUA guidelines up to 2013. We're doing better, but not much better," says Megan Prunty, MD.

“The combination of NAI plus BCG was safe, it was effective, and it serves as a feasible and viable alternative to other agents in this disease space,” says Karim Chamie, MD.

The FDA will be evaluating findings from cohorts A and K from the phase 1b/2 EV-103 trial.

“First and foremost, it’s great that we have multiple lines of therapy for our bladder cancer patients,” says Tanya Dorff, MD.

Nadofaragene firadenovec is a non-replicating adenoviral vector based gene therapy.

"It is safe to give 24 hours or less of antibiotics for radical cystectomy. It does not decrease your infectious complications to have extended duration antibiotics," says Megan Prunty, MD.

The phase 2 trial is assessing the MetAP2 inhibitor APL-1202 and the PD-1 inhibitor tislelizumab as a non-chemotherapy–based neoadjuvant regimen for patients with muscular invasive bladder cancer.