Bladder Cancer

Panelists discuss whether the trial results support investigating cretostimogene with other checkpoint inhibitors and provide insights into notable ongoing trials exploring cretostimogene for intermediate- or high-risk NMIBC, such as BOND-003 and PIVOT-006.

“Our study highlights critical gaps in health care equity when it comes to treatments that have been shown effective in prolonging survival,” says Solomon Woldu, MD.

“Even if they're postmenopausal, we remove the ovaries, which puts them at a higher risk for other complications such as osteopenia,” says Laura Bukavina, MD, MPH, MSc.

“So, while the natural epidemiological prevalence of disease is only 20% to 30%, we really should aim for studies where we can oversample the females to make sure that that medication truly is doing what it's doing in both males and females,” says Laura Bukavina, MD, MPH, MS.

"We have now realized that in some patients with a low number of metastatic sites, providing systemic treatment and providing some site-targeted treatment will provide lasting benefit or at least a temporary benefit that will help ameliorate the need for the systemic treatments or very intense systemic treatments," says Armine K. Smith, MD.

The approval is based on findings from the first interim analysis of the phase 3 EV-302 trial.

Panelists discuss how the combination therapy of cretostimogene plus pembrolizumab offers a promising new approach for managing BCG-unresponsive non-muscle-invasive bladder cancer, highlighting its potential benefits and the implications of its FDA Breakthrough Therapy Designation for clinical practice.

Key opinion leaders examine the comparative safety profiles and response durations of combination therapy versus monotherapy in the treatment of BCG-unresponsive carcinoma in situ with or without papillary disease.

The phase 3 trial will assess the anti-tumor activity of 9MW2821 plus toripalimab vs chemotherapy in patients with locally advanced or metastatic urothelial carcinoma.

The approval is supported by data from cohort 1 of the phase 3 THOR trial.

The approval is supported by findings from the phase 3 EV-302 trial.

“In the highly selected patient with localized MIBC, an organ-preserving approach to treatment may produce similar oncologic outcomes to radical surgery with a potential for improved QoL, although there is currently insufficient evidence to recommend bladder preservation therapy as a standard of care," the authors write.

The approval for enfortumab vedotin is supported by findings from the global phase 3 EV-301 trial and the phase 2 EV-203 bridging trial in Chinese patients.

Experts discuss the results of the CORE-001 Trial.

Experts compare Cretostimogene and BCG Administration Methods

William Tabayoyong, MD, PhD, highlights the University of Rochester’s upcoming Bladder Cancer Symposium, which will take place on September 14, 2024.

The NDA for UGN-102 is primarily supported by findings from the phase 3 ENVISION trial.

Experts discuss the patient quantity and qualifications for the CORE-001 trial.

Experts give an overview of the ASCO 2024 data.

Patient recruitment for the phase 2 trial is expected to begin by the end of 2024.

With this designation, the development process for 9MW2821 can benefit from prioritized engagement with China’s Center for Drug Evaluation as well as expedited review and approval.

Experts discuss available therapies beyond BCG.

Experts discuss the rate of recurrence following first-line BCG therapy.

"One of the main conclusions that we can take from our study is that although the current classification systems are somewhat accurate, they are far from being perfect," says Félix Guerrero-Ramos, MD, PhD, FEBU.

The CHMP’s positive recommendation is based on findings from the first interim analysis of the phase 3 EV-302 trial.

"There are many opportunities to support our patients with bladder cancer who smoke from their clinic appointments from their intravesical therapy visits to their surveillance cystoscopies," says Marc Bjurlin, DO, MSc, FACOS.

"In the last decade, we've observed a high number of new alternatives within clinical trials, especially with intravesical delivery," says Félix Guerrero-Ramos, MD, PhD, FEBU.

"Our next goal is transitioning to really understand the patient experience and how we can support them to quit smoking cigarettes," says Marc Bjurlin, DO, MSc, FACOS.

"It really opened up an opportunity to provide support for our patients with bladder cancer who smoked in patient after that teachable moment of surgery," says Marc Bjurlin, DO, MSc, FACOS.

There was an overall response rate of 39% among the 18 evaluable patients, including 1 complete response and 6 partial responses.