Bladder Cancer

The recommended phase 2 dose was determined to be rogaratinib at 600 mg in combination with atezolizumab at 1200 mg.

Enfortumab vedotin plus pembrolizumab was previously granted a priority review designation from the MHLW.

According to the authors, these findings from the VOLGA trial suggest that ctDNA may be a potential biomarker to predict therapeutic benefit in patients with MIBC.

At a median follow-up of 9 months, the confirmed objective response rate to disitamab vedotin plus pembrolizumab was 75% in the overall population.

“I think that these data in this approximately 700 patient trial consolidates and makes a strong case for the role of pembrolizumab in the adjuvant setting,” says Guru P. Sonpavde, MD.

"I think the fact that we're having these conversations, that they are being talked about at national meetings, and that we are bringing the patient voice into this is hugely important," says Mary W. Dunn, MSN, NP-C, OCN, RN.

“It's still relatively early, but this study in close to 1000 patients validated this algorithm, and it's now being studied prospectively as well,” says Yair Lotan, MD.

Panelists discuss their views on using cretostimogene as monotherapy versus combination therapy, the importance for urologists to stay updated on advances for managing BCG-unresponsive NMIBC, and the potential impact of combining cretostimogene with pembrolizumab on addressing unmet needs in NMIBC care.

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.