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At the time of data cutoff, 71% of patients achieved a complete response following treatment.

"Together, the data point to the exciting potential for this combination regimen to be used to treat patients with muscle invasive bladder cancer," says Roger Li, MD.

At the end of the induction phase, 86% of patients had achieved a complete response.

The observational LOBSTER study has already enrolled 303 patients and collected 479 samples.

Anti-tumor activity was observed across all patients with FGFR3-altered metastatic urothelial carcinoma who were treated at the dose levels of 90 mg and higher.

The phase 3 ENVISION trial met its primary end point by demonstrating a 79.6% complete response rate at 3 months following the first instillation of the therapy.

The cystoscopy solution was granted a CE mark for regulatory clearance in Europe in October 2023.

The decision to withdraw sacituzumab govitecan from the market was made in consultation with the US FDA following negative data from the phase 3 TROPiCS-04 trial.

Overall, 4 of 5 patients with low-grade disease who received bel-sar with light activation achieved a complete clinical response.

The target action date for the application is June 13, 2025.

"On-going innovation will continue to drive UTUC management forward, and with it will come on-going challenges of how to best study a relatively rare disease," write the authors.

"The biomarker is better at predicting presence of disease than absence, and the reason that that's important is that's how we can think about the biomarker aiding in careful clinical assessment of patients," says Elizabeth R. Plimack, MD, MS, FASCO.

"Overall, TAR-200 is being tested with the aim of changing the therapeutic paradigm of patients with an early bladder cancer diagnosis, including non–muscle-invasive disease and muscle-invasive disease," says Andrea Necchi, MD.

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.