Bladder Cancer

Data from the SunRISe-1 trial showed a complete response rate of 82%, with 51% of patients remaining in complete response for at least 1 year.

At the time of data report, the median progression-free survival and duration of response had not been reached in either cohort.

CG Oncology plans to initiate a BLA submission with the FDA in Q4 of 2025.

The LEGEND trial is evaluating detalimogene voraplasmid in patients with high-risk non–muscle invasive bladder cancer.

The trial is assessing RFS rates with cretostimogene grenadenorepvec vs surveillance following TURBT.

Predicine has submitted the first module of a PMA application for their urine cfDNA NGS assay PredicineCARE.

Sandip M. Prasad, MD, MPhil, outlines 3 key takeaways from the ENVISION trial, which evaluated mitomycin for intravesical solution in patients with LG-IR-NMIBC.

Rian J. Dickstein, MD, provides an overview of detalimogene voraplasmid, currently being evaluated for the treatment of non–muscle invasive bladder cancer.

Sandip M. Prasad, MD, MPhil, discusses the safety profile for mitomycin for intravesical solution based on data from the ENVISION trial.

Take a look through the novel agents that are set to further redefine the treatment landscape for high-risk BCG-unresponsive NMIBC.

Robert B. Den, MD, outlines the exploratory applications of the Alpha DaRT technology across the prostate and bladder cancer landscapes.

The company is engaged in discussions with the FDA surrounding the initiation of a pivotal phase 3 trial of Alpha1H.

Patients who were Signatera positive and received treatment with atezolizumab had a statistically significant and clinically meaningful improvement in DFS and OS.

Sandip M. Prasad, MD, MPhil, details key findings from the phase 3 ENVISION trial, which supported the approval of mitomycin intravesical solution in LG-IR-NMIBC.

Suzanne B. Merrill, MD, FACS, unpacks key findings from the CREST trial and outlines data of interest from the POTOMAC and PATAPSCO trials, which are set to read out later this year.

The ARCHER trial is seeking to determine whether ultra-hypofractionated radiotherapy is non-inferior to hypofractionated radiotherapy in terms of bladder-intact event-free survival.

Urologists from the University of North Carolina share insights into key advancements across the field of urologic oncology.

Sandip M. Prasad, MD, MPhil, shares his thoughts on the impact of the FDA approval of mitomycin for intravesical solution for patients with LG-IR-NMIBC.

An interim analysis of the data showed that the trial met its primary end point of EFS, as well as the key secondary end points of OS and pCR rate.

This marks the first and only approval of a perioperative immunotherapy in this disease setting in Canada.

Suzanne B. Merrill, MD, FACS explains the challenges with BCG monotherapy and the emergence of novel regimens combining BCG with ICIs in high-risk NMIBC.

In the phase 3 RC48-C016 study, disitamab vedotin plus toripalimab significantly improved PFS and OS vs chemotherapy.

In this interview, Tom Jayram, MD, offers insights into how BCG plus immune checkpoint inhibitors may redefine the treatment landscape in BCG-naïve NMIBC.

A phase 3 registrational trial of NDV-01 is expected in the first half of 2026.

Take a look through key stories from last month, including regulatory news, trial updates, and other practice-changing advancements.