© 2025 HSP News Service, L.L.C.
Two recent studies have offered new insights into the treatment of muscle-invasive urothelial carcinoma following cystectomy, according to findings presented by Powles et al and Galsky et al at the European Association of Urology Congress 2024. The research could allow physicians to target...
About 8 years ago, I was just a few years into menopause when I noticed blood in my urine. It wasn’t accompanied by pain, frequent urination, or any other troubling symptoms, so initially I wasn’t too concerned. But when I started passing pieces of tissue, I became alarmed and made an appointment...
On December 15, 2023, enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) was approved for patients with locally advanced or metastatic urothelial cancer.1,2 Supporting Efficacy Data Approval was based on findings in the open-label EV-302 trial (ClinicalTrials.gov...
On January 19, 2024, erdafitinib (Balversa) was approved for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by a U.S. Food & Drug Administration–approved companion diagnostic test, whose disease has progressed on or...
Adjuvant use of the PD-1 inhibitor pembrolizumab achieved a statistically significant and clinically meaningful improvement in disease-free survival in patients with high-risk muscle-invasive urothelial carcinoma vs observation after surgical resection, according to an interim analysis of the phase ...
The combination of the nectin-4–directed antibody-drug conjugate enfortumab vedotin-ejfv plus the PD-1 inhibitor pembrolizumab achieved favorable rates of progression-free survival, overall survival, and objective responses compared with chemotherapy among key subgroups of patients with previously...
As reported in The New England Journal of Medicine by Thomas Powles, MD, and colleagues, the phase III EV-302 trial has shown that the combination of the antibody-drug conjugate enfortumab vedotin-ejfv and the PD-1 inhibitor pembrolizumab improved progression-free and overall survival vs...
On March 6, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. CheckMate 901 Efficacy was evaluated in CheckMate ...
The established dual HER2 blockade of pertuzumab and trastuzumab may be an effective treatment for patients with several types of HER2-amplified cancers, according to a study published by Connolly et al in Clinical Cancer Research. Background HER2 receptors control how cells grow and divide. The...
As reported by Katims et al in JAMA Oncology, long-term follow-up of a single-center phase II study showed benefit with two induction courses of bacillus Calmette-Guérin (BCG) without maintenance in patients with high-risk non–muscle-invasive bladder cancer. The strategy markedly reduced the number ...
As reported in the Journal of Clinical Oncology by Alison Jane Birtle, MD, MBBS, MRCP, FRCR, and colleagues, final results of the UK-based phase III POUT trial showed survival benefits with adjuvant platinum-based chemotherapy vs surveillance after radical nephroureterectomy in patients with upper...
Investigators may have found a significant unmet need for improved analyses and reporting of patient-reported outcomes in genitourinary cancer clinical trials, according to a recent study published by Paravathaneni et al in eClinicalMedicine. Background Genitourinary cancers affect over 444,000...
Andrea B. Apolo, MD, of the National Cancer Institute, National Institutes of Health, discusses the results of the AMBASSADOR Alliance A031501 study, which showed adjuvant pembrolizumab improved disease-free survival vs observation for patients with high-risk muscle-invasive urothelial carcinoma after radical surgery. According to Dr. Apolo, the findings support adjuvant pembrolizumab as a new treatment option for this population (Abstract LBA531).
Rohit K. Jain, MD, MPH, of the H. Lee Moffitt Cancer Center and Research Institute, discusses a novel phase II trial of pembrolizumab plus cabozantinib. The study showed this combination may be efficacious as first-line therapy for patients with metastatic urothelial carcinoma, including those who are ineligible for cisplatin. Further investigation with a focus on predictive biomarkers is ongoing (Abstract 539).
Bishoy M. Faltas, MD, of Weill Cornell Medicine, discusses the biology of upper tract urothelial carcinoma and how it affects treatment, noting that most of these tumors are luminal papillary with a T-cell–depleted immune contexture driven by FGFR3 activation. Phase III trials have confirmed the predicted differential effects of FGFR3 inhibitors in this type of tumor compared with bladder cancer based on biological differences.
David H. Aggen, MD, PhD, of Memorial Sloan Kettering Cancer Center, discusses reportedly the first data to describe an inverse correlation between HER2 immunohistochemistry expression and PD-L1 combined positive score. According to Dr. Aggen, these and other findings by his team may provide a foundation for further HER2-directed advanced bladder cancer studies (Abstract 538).
Michiel S. Van Der Heijden, MD, PhD, of the Netherlands Cancer Institute, discusses phase III results from the global EV-302 study, showing that enfortumab vedotin-ejfv plus pembrolizumab improves outcomes in patients with previously untreated locally advanced metastatic urothelial carcinoma compared with chemotherapy. Overall survival benefit was observed across select prespecified subgroups. According to Dr. Van Der Heijden, this immunotherapy combination is a potential new standard of care for first-line locally advanced metastatic urothelial carcinoma (Abstract LBA530).
Syed Muneeb Alam, MD, of Memorial Sloan Kettering Cancer Center, discusses study findings evaluating links among microsatellite instability status, tumor mutational burden, and response to immune checkpoint blockade in patients with microsatellite instability–high urothelial carcinoma (Abstract 536).
In a cohort of the phase II TROPHY-U-01 trial (cohort 3) reported in the Journal of Clinical Oncology, Petros Grivas, MD, PhD, and colleagues found that the combination of sacituzumab govitecan-hziy and pembrolizumab showed activity in patients with metastatic urothelial cancer and disease...
Amanda Nizam, MD, of the Cleveland Clinic, discusses results from the UNITE study, which shows patients with advanced urothelial cancer who were treated with enfortumab vedotin-ejfv (EV) after switch maintenance avelumab had outcomes consistent with data with EV in platinum- and immune checkpoint inhibitor–refractory disease (Abstract 537).
Subsequent systemic therapy with the immune checkpoint inhibitor nivolumab may offer overall survival benefit in patients with muscle-invasive urothelial carcinoma who underwent surgery to remove their tumors, according to recent findings presented by Geynisman et al at the 2024 ASCO Genitourinary...
Patients with muscle-invasive urothelial cancer and a high risk of recurrence after surgery may have a new treatment option. The Alliance for Clinical Trials in Oncology announced positive results from the phase III AMBASSADOR (A031501) trial for the adjuvant treatment of patients with localized...
On January 19, the U.S. Food and Drug Administration (FDA) approved the FGFR inhibitor erdafitinib (Balversa) for adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose...
As reported in The Lancet Oncology by Pfister et al, a 5-year analysis of the French phase III VESPER trial showed no improvement in overall survival with dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) vs gemcitabine and cisplatin (GC) in the total perioperative...
In a final overall survival analysis of the phase III IMvigor130 trial reported in The Lancet Oncology, Enrique Grande, MD, and colleagues found no significant advantage in overall survival with atezolizumab plus chemotherapy vs chemotherapy alone in the first-line treatment of patients with...
In the final overall survival analysis from the phase III IMvigor130 trial reported in The Lancet Oncology, Aristotelis Bamias, MD, and colleagues found no significant advantage in overall survival with atezolizumab monotherapy vs chemotherapy in untreated patients with locally advanced or...
On December 15, 2023, the Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer. The FDA previously granted accelerated approval to this combination for patients...
Mark D. Tyson, MD, MPH, of the Mayo Clinic School of Graduate Medical Education, discusses the first results from BOND-003, a phase III study of intravesical cretostimogene grenadenorepvec monotherapy for patients with high-risk non–muscle-invasive bladder cancer that does not respond to Bacillus Calmette-Guérin (BCG) immunotherapy. Recently, the U.S. Food and Drug Administration granted cretostimogene monotherapy Fast Track status in BCG-unresponsive carcinoma in situ with or without Ta/T1 papillary disease.
As reported in The New England Journal of Medicine by Yohann Loriot, MD, PhD, and colleagues, cohort 1 of the phase III THOR trial has shown improved overall survival with erdafitinib vs chemotherapy in patients with locally advanced, unresectable, or metastatic urothelial carcinoma with...
In a combined analysis of two Chinese phase II trials (RC48-C005 and RC48-C009) reported in the Journal of Clinical Oncology, Sheng et al found that the antibody-drug conjugate disitamab vedotin—an anti-HER2 antibody conjugated with monomethyl auristatin—produced promising results in patients with...
Two phase III trials presented at a Presidential Symposium during the European Society for Medical Oncology (ESMO) Congress 2023 showed an overall survival benefit for patients with advanced urothelial cancer. The results from both studies were hailed as practice-changing. The EV-302/KEYNOTE-A39...
Two phase III trials presented at a Presidential Symposium during the European Society for Medical Oncology (ESMO) Congress 2023 showed an overall survival benefit for patients with advanced urothelial cancer. The results from both studies were hailed as practice-changing. The EV-302/KEYNOTE-A39...
Researchers have found that nivolumab in combination with a chemotherapy regimen may improve the rate of survival in patients with metastatic urothelial carcinoma, according to new findings simultaneously published by van der Heijden et al in The New England Journal of Medicine and presented at the ...
Targeted treatment with the fibroblast growth factor receptor (FGFR) inhibitor erdafitinib improved responses and overall survival compared to standard chemotherapy for patients with advanced or metastatic urothelial carcinoma with FGFR alterations. Results from the phase III THOR trial, led by...
The Alliance Data and Safety Monitoring Board has determined that adjuvant pembrolizumab may improve disease-free survival in patients with localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma, according to the Alliance for Clinical Trials in Oncology. ...
In a Swiss phase II study (SAKK 06/17) reported in the Journal of Clinical Oncology, Richard Cathomas, MD, and colleagues found that the addition of perioperative durvalumab to neoadjuvant chemotherapy resulted in improved event-free and overall survival in patients with muscle-invasive urothelial...
Researchers have found that the new PENK methylation (mePENK) test could potentially pave the way for a breakthrough in early bladder cancer detection in patients with hematuria, according to a novel study published by Oh et al in The Journal of Molecular Diagnostics. The findings could reduce the...
Xin Gao, MD, Assistant Professor, Harvard Medical School, Genitourinary Cancers Program, Mass General Cancer Center, commented on the results from TROPHY-U-01 cohort 2. “These data add to the overall data on the efficacy of sacituzumab govitecan in patients with metastatic urothelial cancer. This...
Treatment with the antibody-drug conjugate sacituzumab govitecan-hziy achieved an objective response rate of 32% in platinum-ineligible patients with metastatic urothelial cancer who experienced disease progression on an immune checkpoint inhibitor, according to the primary analysis of the...
With longer-term follow-up, adjuvant nivolumab continued to demonstrate improved disease-free survival, non–urothelial tract recurrence–free survival, and distant metastasis–free survival vs placebo in patients with muscle-invasive urothelial carcinoma at high risk of recurrence after surgery,...
“Clinically, the implications [of the THOR trial] are clear in that all metastatic urothelial cancers should be tested for FGFR mutations,” stated invited discussant Daniel P. Petrylak, MD, of Yale School of Medicine. “This should be done at the beginning of treatment for metastatic disease, as it...
Targeted treatment with the fibroblast growth factor receptor (FGFR) inhibitor erdafitinib significantly improved overall survival, progression-free survival, and objective response rates compared with investigator’s choice of chemotherapy in patients with advanced urothelial cancers and FGFR2/3...
It is an exciting time in the development of new treatments for urologic cancers. There have been a number of major changes both in advanced disease and in the perioperative setting over the past year. Urothelial and Bladder Cancers In urothelial cancer, at last, we have randomized data supporting...
In a retrospective study reported in the Journal of Clinical Oncology, Swinton et al found that bladder-sparing trimodal therapy with radical-dose radiotherapy was an effective alternative to radical cystectomy in patients with clinically node-positive nonmetastatic bladder cancer. As stated by the ...
“Clinically, the implications [of the THOR trial] are clear in that all metastatic urothelial cancers should be tested for FGFR mutations,” stated invited discussant Daniel P. Petrylak, MD, of Yale School of Medicine. “This should be done at the beginning of treatment for metastatic disease, as it...
Targeted treatment with the fibroblast growth factor receptor (FGFR) inhibitor erdafitinib significantly improved overall survival, progression-free survival, and objective response rates compared with investigator’s choice of chemotherapy in patients with advanced urothelial cancers and FGFR2/3...
As reported in the Journal of Clinical Oncology by O’Donnell et al, findings in a cohort of the phase Ib/II EV-103/KEYNOTE-869 study showed durable responses with first-line enfortumab vedotin-ejfv plus pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial...
Researchers have identified a new potential therapeutic target—the cell-surface tumor antigen CUB domain–containing protein 1 (CDCP1)—for patients with all subtypes of metastatic bladder cancer, according to findings presented by Chopra et al at the Society of Nuclear Medicine & Molecular...
Researchers have found that the loss of the Y chromosome, a common impact of the aging process in men, may help cancer cells evade the body’s immune system and result in aggressive bladder cancer—but it may also render the disease more vulnerable and responsive to immune checkpoint...
In a study reported in JAMA Network Open, Weinberg et al found that receipt of the bacillus Calmette-Guérin (BCG) vaccine in patients with non–muscle-invasive bladder cancer was associated with a lower risk of Alzheimer’s disease and related dementias—as well as a lower risk of mortality—compared...