Bladder Cancer

"The implication for real-world decision-making is that this drug appears to hold up to what was seen in the trial," says Mark D. Tyson II, MD, MPH.

"These data support current AUA/SUO guidelines recommending BLC usage in patients with NMIBC to increase detection and decrease recurrence," says Stephen B. Williams, MD, MBA, MS, FACS, FACHE.

"Ultimately, there is no 'right choice' when it comes to urinary diversion," writes Anne K. Schuckman, MD.

There are also 60 sites in the process of launching the EAP.

The pCR rate was 33% with APL-1202 plus tislelizumab compared with 26% with tislelizumab alone.

According to ImmunityBio, shipments of rBCG are set to begin immediately via the EAP.

Panelists discuss how it would be preferred that BCG monotherapy not remain the first-line treatment for intermediate-risk and high-risk disease within the next 10 years. It is encouraged that the future of first-line treatment be a noninfectious agent that would be easier to develop and include more data.

Panelists discuss how PD-L1 inhibitors such as durvalumab and sasanlimab represent a promising frontier in non–muscle-invasive bladder cancer (NMIBC) treatment. These immunotherapies work by unleashing the body’s immune response against cancer cells, potentially offering new options for patients whose disease doesn’t respond to conventional therapies such as BCG. Their ongoing phase 3 trials could establish immunotherapy as a valuable addition to the NMIBC treatment landscape.

“Among active surveillance patients, 82% are metastases-free, and 60% were metastases-free and had an intact, unradiated bladder,” said Pooja Ghatalia, MD.

Anktiva is also currently under review for the CIS indication in the EU.

"The results [indicate] that neoadjuvant DV combined with toripalimab had promising efficacy and acceptable safety in patients with HER2-expressing MIBC,” said Xinan Sheng, MD.

The pCR was 37.3% (95% CI, 33.2-41.6) in the durvalumab arm and 27.5% (95% CI, 23.8-31.6) in the comparator arm.

OS was found to be prolonged with avelumab plus BSC vs BSC alone regardless of diabetes mellitus status.

The investigators reported that there were 24 evaluable patients with CIS with/without papillary disease, of whom 79% had a CR at 3 months.

The median duration of response was 47.8 months among patients who achieved an initial complete response.

Panelists discuss how both TAR-200 and UGN-102/103 represent innovative approaches to intravesical drug delivery for bladder conditions. TAR-200 uses a novel silicone-based system designed for controlled gemcitabine release, potentially offering extended drug exposure compared with conventional instillations. UGN-102 and UGN-103 employ a proprietary RTGel technology that transforms from liquid to gel form at body temperature, allowing for longer retention of mitomycin (UGN-102) and high-dose botulinum toxin (UGN-103), respectively, in the bladder.

Panelists discuss how cretostimogene grenadenorepvec is an intravesical oncolytic virus therapy targeting BCG-unresponsive bladder cancer through selective replication in tumor cells and immune stimulation via granulocyte-macrophage colony-stimulating factor expression.

"One way to think about how Anktiva works is it is the first molecule, based on the package insert, that increases and proliferates the NK cells, the T cells, and the CD4+ and CD8+ T cells, without up-regulating the suppressive T cells," says Patrick Soon-Shiong, MD.

In total, 28% of patients with luminal tumors and 41% of patients with nonluminal tumors experienced upstaging to nonorgan confined disease.

Panelists discuss how for patients with BCG-unresponsive bladder cancer, treatment selection depends on key factors including tumor characteristics (carcinoma in situ vs papillary), patient fitness, and preferences. Standard options include radical cystectomy (the gold standard) or bladder-preserving approaches such as pembrolizumab, intravesical chemotherapy, or clinical trials. The decision requires careful individualization based on risk stratification, comorbidities, and shared decision-making.

Panelists discuss how FDA approvals have expanded options for BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), with pembrolizumab, nogapendekin alfa inbakicept-pmln, and nadofaragene firadenovec-vncg offering new immunotherapy and gene therapy approaches.

A recap of the FDA submissions and regulatory decisions in urology from January 2025.

“Black patients have over 2-fold excess mortality compared to White men, and that has been fairly consistent; the actual rate ratio has hovered between 2 and 2.5 for many years,” says Matthew R. Cooperberg, MD, MPH.

A list of facts and trends to know about the current landscape of urologic cancer management and research in the US.

Two recent roundtable discussions focused on the challenges and evolving treatment strategies in upper tract urothelial carcinoma.

Panelists discuss how BCG-unresponsive bladder cancer is defined by disease persistence/recurrence within 6 to 12 months of adequate BCG therapy. Treatment options include cystectomy, intravesical chemotherapy, immunotherapy, or clinical trials.

Panelists discuss how low-risk non–muscle-invasive bladder cancer (NMIBC) requires transurethral resection of bladder tumor (TURBT) with surveillance. Intermediate-risk disease needs adjuvant intravesical chemotherapy. High-risk cases receive BCG induction/maintenance therapy after TURBT, with close monitoring.

Check out the key regulatory decisions set to happen early this year.

If approved, the marketing authorization application would be valid in all 27 European Union member states as well as in Iceland, Liechtenstein, and Norway.

"The three-year durability data from this study further validate the potential of JELMYTO in providing long-term disease control for patients with low-grade upper tract urothelial cancer,” says Solomon L. Woldu, MD.