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Data from the phase 3 BART trial shows adjuvant radiotherapy is notably safe for patients with MIBC following radical cystectomy and chemotherapy.

In total, the phase 3 UTOPIA trial plans to enroll 87 patients with LG-IR-NMIBC to assess the safety and efficacy of UGN-103.

The phase 3 ENLIGHTED trial has reached the 50% patient enrollment threshold.

"This exciting and innovative technology has a wide range of possible applications, including tissue engineering, drug development, and precision medicine," write Kate Gessner, MD, PhD, and Philip Abbosh, MD, PhD.

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 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.

“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.

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

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.

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.

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.

"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.

"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.

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

“The MAT2A-Trop2 ADC combination targets 2 distinct, yet complementary nodes in patients with MTAP-deleted urothelial cancer and has first-in-class potential to improve clinical outcomes for bladder cancer patients with poor prognosis associated with MTAP-deletion," says Darrin M. Beaupre, MD, PhD.

“These NIAGARA data show for the first time that adding durvalumab to chemotherapy before surgery followed by durvalumab extends patients’ lives," says Thomas Powles, MD.

Subcutaneous nivolumab is also under review in the United States based on findings from the phase 3 CheckMate-67T trial.

N-803 was approved by the FDA in April 2024 for the treatment of patients with BCG-unresponsive NMIBC carcinoma in situ with or without papillary tumors.

Cretostimogene grenadenorepvec is an intravesical oncolytic immunotherapy currently under investigation in phase 3 trials.

The 12-month duration of response was 82.3% among patients with LG-IR-NMIBC who achieved a complete response at 3 months following the first UGN-102 instillation.