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As reported in Journal of Clinical Oncology by Dahl et al, a phase II trial (NRG Oncology/RTOG 0926) has shown good outcomes with bladder-preserving trimodality the�rapy for recurrent high-grade T1 bladder cancer among patients in whom bacillus Calmette-Guérin therapy failed. Study Details In the...
In cohort 2 of the phase II TROPHY-U-01 study, reported in the Journal of Clinical Oncology, Petrylak et al found that sacituzumab govitecan-hziy was active in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer progressing after immune checkpoint inhibitor (ICI)...
On March 6, 2024, nivolumab (Opdivo) was approved for use in combination with cisplatin and gemcitabine for first-line treatment of patients with unresectable or metastatic urothelial carcinoma.1 Supporting Efficacy Data Approval was based on the open-label CheckMate 901 trial (ClinicalTrials.gov ...
The combination of nivolumab plus gemcitabine/cisplatin chemotherapy achieved high response rates and durable responses and improved overall survival and progression-free survival compared with gemcitabine/cisplatin chemotherapy alone in patients with urothelial carcinoma and clinical evidence of...
The presence of a mutation in any one of three genes known to be involved in DNA damage repair may be associated with complete pathologic response to cisplatin-based neoadjuvant chemotherapy, as measured by pathologic downstaging at the time of cystectomy in patients with muscle-invasive urothelial ...
Agricultural pesticides may carry a similar risk as smoking for some types of cancers, according to a recent study published by Gerken et al in Frontiers in Cancer Control and Society. Background In modern agriculture practices, pesticides are essential to ensure high enough crop yields and food...
As reported in the Journal of Clinical Oncology by Andrea B. Apolo, MD, and colleagues, findings in expansion cohorts of a phase I study showed the activity of cabozantinib/nivolumab alone or with the addition of ipilimumab in patients with advanced/metastatic genitourinary (GU) tumors. Study...
On April 22, 2024, the interleukin-15 receptor agonist nogapendekin alfa inbakicept-pmln was approved for use with bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.1 Supporting Efficacy Data...
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, and Thomas Powles, MD, PhD, of Barts Cancer Institute and the University of London, discuss phase III findings from two studies: the first, investigating enfortumab vedotin-ejfv and pembrolizumab vs platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic urothelial cancer; and the second, looking at nivolumab plus gemcitabine and cisplatin vs gemcitabine and cisplatin alone in patients with lymph node–only metastatic disease enrolled in the CheckMate 901 trial (Abstracts 4581 and 4565).
Thomas Powles, MD, PhD, of Barts Cancer Institute and the University of London, and Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discuss clinical outcomes of sacituzumab govitecan-hziy after prior exposure to enfortumab vedotin-ejfv in patients with metastatic urothelial carcinoma, as well as the safety and efficacy of fam-trastuzumab deruxtecan-nxki in patients with HER2-expressing bladder tumors (Abstracts 4502 and 4509).
As reported in The Lancet Oncology by Andrea Necchi, MD, and colleagues, findings in cohort B of the phase II KEYNOTE-057 study indicated that pembrolizumab was active in patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non–muscle invasive bladder cancer. As noted by the...
In a German-Austrian phase II study (TITAN-TCC) reported in JAMA Oncology, Grimm et al described outcomes with the use of nivolumab plus ipilimumab as an immunotherapeutic boost in metastatic urothelial carcinoma. Study Details In the multicenter trial, 169 patients were enrolled into two cohorts...
The National Comprehensive Cancer Network® published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in 1996, covering eight tumor types. Currently, guidelines are available for more than 60 tumor types, subtypes, and related topics. The NCCN’s 29th Annual Conference...
As reported in The New England Journal of Medicine by Thomas Powles, MD, Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, and colleagues, the phase III EV-302 trial has shown that the combination of the antibody–drug conjugate enfortumab vedotin-ejfv, which is...
In a study reported in the Journal of Clinical Oncology, Klümper et al established a fluorescence in situ hybridization (FISH) assay to measure NECTIN4 copy number variations and found that NECTIN4 amplification was associated with high activity of the anti-NECTIN4 antibody-drug conjugate...
The American Urological Association (AUA), in partnership with ASCO and the Society of Urologic Oncology (SUO), has issued a 2024 clinical practice guideline amendment for the diagnosis and treatment of nonmetastatic muscle-invasive bladder cancer. The updated guidelines were published by...
On April 22, the U.S. Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva) with bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. QUILT-3.032 Trial Efficacy...
Researchers have found that a novel urine biomarker test may effectively halve the number of cystoscopies necessary in high-risk patients with bladder cancer, according to recent findings presented by Dreyer et al at the European Association of Urology (EAU) Congress 2024. The research also...
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...