Bladder Cancer

Michiel S. Van der Heijden, MD, PhD, discusses the methods, design, and findings of the phase 3 CheckMate 901 trial of concurrent frontline nivolumab and chemotherapy followed by nivolumab maintenance therapy in urothelial carcinoma.

Available data on patient-reported outcomes and positive interim results from QUILT 3.032 support N-803 for patients with Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer.

In an interview with Targeted Oncology, Stephen Williams, MD, discussed a retrospective cohort study presented at ASCO GU analyzing intravesical gemcitabine usage vs Bacillus Calmette-Guérin for the treatment of high-risk non-muscle invasive bladder cancer.

Michiel S. Van der Heijden, MD, PhD, discusses background of the phase 3 CheckMate 901 study which evaluated concurrent frontline nivolumab and gemcitabine/cisplatin followed by nivolumab maintenance therapy among patients with urothelial carcinoma.

In an interview with Targeted Oncology, Thomas Powles, MD, MBBS, MRCP, discussed the impressive performance of enfortumab vedotin plus pembrolizumab for the treatment of locally advanced or metastatic urothelial carcinoma, as seen in the EV-302 trial.

Research across kidney, bladder, and prostate cancers was showcased January 25-27 in San Francisco, California.

The phase 3 AMBASSADOR Alliance A031501 trial of adjuvant pembrolizumab in muscle-invasive and locally advanced urothelial carcinoma successfully achieved its primary end point. However, the interim analysis did not meet the overall survival end point.

The phase 3 EV-302/KEYNOTE-A39 trial, which includes prespecified subgroup analyses, revealed favorable outcomes compared with chemotherapy. The findings pertain to patients with previously untreated locally advanced or metastatic urothelial carcinoma.

Pembrolizumab and cabozantinib showed promising results as first-line treatment for advanced urothelial carcinoma, including those who were ineligible for cisplatin.

In patients with non-muscle-invasive bladder cancer unresponsive to BCG who underwent nadofaragene firadenovec (Adstiladrin) treatment, those who achieved urinary minimal residual disease (uMRD)-negative status showed no recurrences.

Joseph M. Jacob, MD, discusses the key takeaways from the SunRISe-1 study and data presented at the 2024 Genitourinary Cancers Symposium.

The FDA has approved erdafitinib for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR3 alterations.

Three-year data showed durable clinical activity with nadofaragene firadenovec-vncg in patients with high-risk, BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.

The gene therapy, nadofaragene firadenovec-vncg, is now fully available across the United States for patients with this aggressive bladder cancer.

In the phase 3 BOND-003 trial, cretostimogene grenadenorepvec led to complete responses in over three-fourths of patients with high-risk BCG-unresponsive non–muscle-invasive bladder cancer.

According to John M. Burke, MD, it is hard to imagine that results presented at ESMO in the urothelial cancer space will not lead to the complete replacement of conventional chemotherapy as the standard first-line treatment.

BCG-unresponsive NMIBC requires vigilant surveillance during new treatments to avoid missing signs of progression and avoid delaying cystectomy, which remains the best chance for cure if intravesical therapies are failing.

Guru P. Sonpavde, MD, provides insights on the phase 3 CheckMate 901 trial and explains what a community oncologist should know about the use of concurrent frontline nivolumab plus chemotherapy in metastatic or unresectable urothelial carcinoma based on this study.

The FDA has granted approval to the combination of enfortumab vedotin-ejfv and pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer.

BCG-unresponsive non-muscle invasive bladder cancer has multiple emerging treatment options in trials showing good response rates, though optimal sequencing remains to be determined.

TAR-200 is being studied for carcinoma in situ with or without papillary disease since it addresses diffuse CIS that cannot be surgically removed, though future trials will expand to papillary disease as adjuvant therapy like BCG, with the goal of extending the disease-free period before potentially reintroducing therapy as needed.

The TAR-200 treatment has demonstrated a favorable safety profile in clinical trial, with primarily low-grade irritated voiding symptoms that are manageable and expected with intravesical therapy, without concerning systemic side effects, making it a promising new option to delay or reduce radical cystectomy in patients with BCG-unresponsive NMIBC.

The TAR-200 treatment for BCG-unresponsive NMIBC works through a catheter-placed intravesical device that elutes gemcitabine over 3 weeks, providing a high complete response rate of 77% in early testing, likely due to the sustained release mechanism.

The FDA has granted 2 designations to cretostimogene grenadenorepvec, an oncolytic immunotherapy, for the treatment of a specific type of high-risk bladder cancer:

TAR-200, a novel targeted therapy, has been granted breakthrough therapy designation by the FDA in high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin.