© 2023 HSP News Service, L.L.C.
Roche has announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining the accelerated approval of atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for...
Social media platforms are valuable tools for educating patients about serious health topics, but they can also spread false and biased information with potentially harmful results, according to recent research published by Stacy Loeb, MD, MSc, and colleagues in European Urology. Researchers...
Landmark changes in the treatment of genitourinary cancers have occurred over the past year, as summarized in this year’s Genitourinary Oncology Almanac from The ASCO Post. Starting with our area of focus, metastatic renal cell carcinoma, the saga continues with two more positive phase III trials...
Recently, the U.S. Food and Drug Administration (FDA) issued regulatory decisions related to treatments for urothelial cancer, cervical cancer, cholangiocarcinoma, solid tumors, and colorectal cancer. Acceptance of Two Supplemental Biologics License Applications for Enfortumab Vedotin-ejfv in...
Enrique Grande, MD, PhD, of The University of Texas MD Anderson Cancer Center, Madrid, discusses phase III overall survival results from the IMvigor130 study of atezolizumab plus platinum and gemcitabine vs placebo plus platinum and gemcitabine in patients with previously untreated metastatic urothelial carcinoma (Abstract CT187).
On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor....
Enfortumab vedotin-ejfv continues to move the needle forward as a validated treatment option for advanced urothelial carcinoma. At the 2021 Genitourinary Cancers Symposium, results from the phase III EV-301 study1 and EV-201 Cohort 22 provided support for the use of this agent in both patients...
As reported in The Lancet Oncology by Joaquim Bellmunt, MD, PhD, and colleagues, the phase III IMvigor010 trial showed no improvement in disease-free survival with adjuvant atezolizumab vs observation in patients with muscle-invasive urothelial carcinoma. Study Details In the open-label trial, 809...
Adjuvant therapy with nivolumab, an anti–PD-1 immune checkpoint inhibitor, after radical surgery improved disease-free survival in high-risk muscle-invasive urothelial cancer regardless of PD-L1 status, according to the results of the CheckMate 274 randomized phase III trial presented at the 2021...
Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, discusses the changing therapeutic landscape in which atezolizumab, avelumab, and pembrolizumab have either been approved or are under review for treating urothelial bladder cancer in the metastatic, superficial, and adjuvant settings.
Recently, the U.S. Food and Drug Administration (FDA) announced that the agency will hold a public meeting of the Oncologic Drugs Advisory Committee on April 27 to 29 to discuss six indications granted accelerated approval that have since reported results from confirmatory trials that have not...
Genentech, a member of the Roche Group, announced on March 8 that the company is voluntarily withdrawing the U.S. indication for atezolizumab (Tecentriq) in patients with prior platinum-treated metastatic urothelial carcinoma. This decision was made in consultation with the U.S. Food and Drug...
As reported in The New England Journal of Medicine by Powles et al, a prespecified interim analysis of the phase III EV-301 trial has shown improved overall survival with enfortumab vedotin-ejfv vs investigator choice of chemotherapy in patients with previously treated advanced urothelial...
Tracy L. Rose, MD, of the University of North Carolina at Chapel Hill, discusses phase II results of gemcitabine and split-dose cisplatin plus pembrolizumab as neoadjuvant therapy prior to radical cystectomy for patients with muscle-invasive bladder cancer. The trial showed this combination treatment is generally safe and may improve pathologic downstaging, but further study is warranted (Abstract 396).
Elizabeth R. Plimack, MD, of Fox Chase Cancer Center, discusses key abstracts discussed at this year’s meeting on bladder cancer and offers her views on the latest trends and findings (Abstracts 391, 393, 434).
In an individual patient-level meta-analysis of two phase III trials reported in The Lancet Oncology, Choudhury et al found that a hypofractionated radiotherapy regimen was associated with improved invasive locoregional control and similar toxicity vs a standard fractionation regimen in patients...
A spirited discussion ensued when we asked Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, and Thomas Powles, MD, PhD, of Cancer Research UK Barts Centre, to compare notes on how they treat bladder, prostate, and kidney cancers.
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for KRAS G12C–mutated non–small cell lung cancer (NSCLC) and high-risk, bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer. A new drug application for a therapy for Waldenström’s...
Monika Joshi, MD, of Penn State Hershey Cancer Institute, discusses phase II results from the DUART study, which explored the efficacy of concurrent durvalumab, a checkpoint inhibitor, and radiation therapy followed by adjuvant durvalumab in patients with localized urothelial cancer of the bladder (Abstract 398).
Daniel M. Geynisman, MD, of Fox Chase Cancer Center, discusses phase II results from the RETAIN BLADDER study, which sequenced bladder tumor samples while treating patients with neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin chemotherapy. The goal was to increase metastasis-free survival and also preserve the bladder and quality of life (Abstract 397).
Treatment with the antibody-drug conjugate enfortumab vedotin-ejfv has been found to significantly increase survival of patients with metastatic urothelial carcinoma, according to results from the phase III EV-301 clinical trial. These findings were presented by Thomas Powles, MD, PhD, and...
Thomas Powles, MD, PhD, of Cancer Research UK Barts Centre, discusses phase III results from the EV-301 trial, which showed that enfortumab vedotin is the first therapy to demonstrate a significant survival advantage over standard chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma (Abstract 393).
Treatment with the immunotherapy nivolumab with or without cisplatin-based chemotherapy following radical surgery significantly improved disease-free survival in patients with muscle-invasive urothelial carcinoma, irrespective of their PD-L1 status, according to a study that will be presented by...
The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...
As reported in the Journal of Clinical Oncology by Catto et al, the BRAVO-Feasibility study showed that recruitment of patients with high-grade, non–muscle invasive bladder cancer into a randomized trial comparing radical cystectomy vs intravesical bacillus Calmette-Guérin (BCG) proved difficult,...
In a study reported in Nature Communications, Bishoy M. Faltas, MD, of the Department of Medicine, Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York, and colleagues identified common germline-somatic variant interactions in advanced urothelial cancer, with these...
In a study reported in Nature Communications, Vosoughi et al identified common germline-somatic variant interactions in advanced urothelial cancer, with these interactions appearing to play a central role in disease progression. As stated by the investigators, “The prevalence and the biologic...
Patients with muscle-invasive urothelial cancer and postsurgical circulating tumor DNA (ctDNA) positivity have high risk of disease recurrence following cystectomy and experienced improved clinical outcomes with adjuvant atezolizumab as compared to patients undergoing observation. These...
As reported in The Lancet Oncology by Thomas Powles, MD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, the phase III DANUBE trial showed that durvalumab monotherapy did not prolong overall survival vs standard chemotherapy in previously untreated patients with...
Formal discussant Kilian M. Gust, MD, of the Medical University of Austria, Vienna, reminded listeners that JAVELIN Bladder 100 was designed at a time when no checkpoint inhibitor was approved for the treatment of metastatic urothelial cancer. In the past 5 years, five immune checkpoint inhibitors...
A strategy of front-line maintenance treatment with the PD-L1 inhibitor avelumab combined with best supportive care improved both progression-free and overall survival vs best supportive care alone across prespecified subgroups of patients with advanced or metastatic urothelial carcinoma that had...
In his discussion of KEYNOTE-361 and the DANUBE trial, Richard Cathomas, MD, of Kantonsspital, Graubünden, Switzerland, said both studies yielded disappointing results. Overall, in these trials as well as current evidence from other trials, treatment of platinum-eligible (cisplatin or carboplatin)...
Two different phase III studies found that combining an anti–PD-1/PD-L1 checkpoint inhibitor (pembrolizumab in KEYNOTE-361) with platinum-based chemotherapy or with another checkpoint inhibitor (the anti–CTLA-4 antibody tremelimumab in DANUBE) failed to significantly improve overall or...
Bladder preservation with trimodality therapy may be a safe and effective alternative to cystectomy for selected patients with muscle-invasive bladder cancer, according to results from a phase II trial presented by Coen et al at the virtual 2020 American Society for Radiation Oncology (ASTRO)...
In a large, randomized clinical trial, researchers evaluated the immunotherapy drug avelumab for patients with advanced urothelial cancer. The findings of the trial, called the JAVELIN Bladder 100 study, are “very exciting,” even “practice-changing,” said the trial’s co-leader, Petros Grivas, MD,...
Neoadjuvant combination therapy with the anti–CTLA-4 therapy tremelimumab and the anti–PD-1 therapy durvalumab was well tolerated and showed early signs of activity in patients ineligible to receive cisplatin-based chemotherapy, all of whom had tumors with high-risk features that are associated...
Analysis of DNA copy number variants in the cells exfoliated in urine showed improved sensitivity and similar specificity in detecting urothelial carcinoma compared to urine cytology, according to results published by Zeng et al in Clinical Cancer Research. “Urine cytology, which is widely used to...
In a phase II trial reported in JAMA Oncology, Srikala S. Sridhar, MD, MSc, FRCPC, and colleagues found no difference in progression-free survival with nab-paclitaxel vs paclitaxel in patients with platinum-refractory metastatic urothelial cancer. Study Details In the investigator-initiated...
In the phase III JAVELIN Bladder 100 trial reported in The New England Journal of Medicine, Thomas Powles, MD, PhD, and colleagues found that maintenance treatment with avelumab plus best supportive care significantly improved overall survival vs best supportive care alone among patients whose...
In the phase III DANUBE trial, reported in The Lancet Oncology, Thomas Powles, MD, PhD, and colleagues found that durvalumab monotherapy did not prolong overall survival vs standard chemotherapy in previously untreated patients with largely metastatic urothelial carcinoma with high PD-L1...
In a phase I trial reported in the Journal of Clinical Oncology, Andrea B. Apolo, MD, and colleagues found that the combination of cabozantinib and nivolumab, as well as the combination of cabozantinib/nivolumab plus ipilimumab, produced durable responses in patients with metastatic urothelial...
Findings from the JAVELIN Bladder 100 trial were published by Thomas Powles, MD, and colleagues in The New England Journal of Medicine. Researchers reported that the PD-L1 inhibitor avelumab led to a 31% reduction in risk of death, and extended median survival by more than 7 months in patients with ...
Recent evidence indicates that proton pump inhibitors may cause significant changes in the gut microbiota; gut microbiota dysbiosis has been linked to reduced immune checkpoint inhibitor effectiveness. In a retrospective analysis of clinical trials investigating the immune checkpoint inhibitor...
Patients treated for bladder cancer with a radical cystectomy have worse outcomes if they are smokers, according to a systematic review and meta-analysis by Keck Medicine of the University of Southern California (USC). The study appeared in The Journal of Urology.1 “This study is important because...
On June 30, 2020, avelumab was approved for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings in the randomized, multicenter, ...
As reported in The Lancet by Matthew D. Galsky, MD, of Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, and colleagues, the phase III IMvigor130 trial has shown prolonged progression-free survival with first-line atezolizumab plus platinum-based chemotherapy vs...
As reported in the Journal of Clinical Oncology by Jacqueline Vuky, MD, of Oregon Health & Science University, Portland, and colleagues, long-term follow-up in the phase II KEYNOTE-052 study has shown durable responses with first-line pembrolizumab in cisplatin-ineligible locally advanced or...
In a phase II study reported in the Journal of Clinical Oncology,1 Matthew D. Galsky, MD, of The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, and colleagues found that maintenance pembrolizumab produced additional responses and improved progression-free survival vs...
Pembrolizumab: On January 8, 2020, pembrolizumab (Keytruda) was approved by the U.S. Food and Drug Administration (FDA) for bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or...
It may be possible to use a platinum-free combination as first-line treatment for advanced or metastatic urothelial carcinoma in cisplatin-ineligible patients, if the results of the phase Ib/II EV-103 trial hold up. The combination of the newly approved antibody-drug conjugate (enfortumab vedotin)...