Bladder Cancer

"Provided that we will confirm the efficacy data long-term, there is an opportunity to spare, de-escalate a bit, the treatment in select patients, and to expose the patient with inferior risk of developing severe [adverse] effects," says Andrea Necchi, MD.

In patients with intermediate-risk disease, 4 of 5 patients demonstrated a complete response.

"Now with the new translational data indicating that post-treatment close contact precautions are unnecessary, I am confident that cretostimogene will represent a breakthrough in bladder cancer treatment, if approved by the FDA," says Trinity J. Bivalacqua, MD, PhD.

“The addition of the durvalumab did not make treatment more morbid than chemotherapy alone, and it didn't change or increase the surgical complications you saw in the ward," says James W.F. Catto, MBChB, PhD, FRCS.

"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.

"At 3 months, those patients had a 79% complete response rate, which was durable in 74% at 6 months and 60% at 9 months," says Jacob A. Moyer, BS.

"The preliminary results of that study, which is a phase 1/2 dose escalation and dose expansion trial, were presented by Professor Ben Tran last year at the ENA meeting1 and showed a very favorable toxicity profile compared to erdafitinib," says Gopa Iyer, MD.

“[We’re working on] being able to apply the same mechanism and testing and thought that we put into this into stool to give people a precision signature of how they're going to respond or experience toxicity from EV based on their stool microbiome,” says Laura Bukavina, MD, MPH.

“What happens, mechanistically speaking, is that it stimulates the 2 arms of the immune system, both innate immunity as well as the adaptive immunity,” says Kate Chan, MD.

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.