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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)...
As reported in The New England Journal of Medicine by Loriot et al, the fibroblast growth factor receptor 1-4 tyrosine kinase inhibitor erdafitinib showed activity in FGFR-altered advanced urothelial carcinoma.1 The study enrolled patients from sites in 14 countries between May 2015 and March 2018. ...
Maintenance therapy with avelumab and best supportive care significantly prolonged overall survival vs best supportive care alone in patients with advanced urothelial carcinoma that did not progress on first-line platinum-based chemotherapy, according to an interim analysis of the phase III JAVELIN ...
Over the past year, we have seen significant advances in the treatment of prostate, kidney, and urothelial cancers that will benefit patients now and in the future. We have learned about the final results of important clinical trials across multiple genitourinary cancers disease states leading to...
In a single-center phase II trial reported in The Lancet Oncology, Andrea Apolo, MD, and colleagues found that the multikinase inhibitor cabozantinib showed activity in a cohort of patients with platinum-refractory metastatic urothelial carcinoma. As noted by the investigators, in addition to...
Study discussant Daniel Y. Heng, MD, MPH, a medical oncologist at Tom Baker Cancer Centre, University of Calgary, Canada, called the negative trial results important. IMvigor010 randomly assigned patients with high-risk muscle-invasive urothelial carcinoma to adjuvant atezolizumab or observation...
Adjuvant atezolizumab, a PD-L1–blocking antibody, failed to meet the primary endpoint of disease-free survival in patients at high risk of recurrence of muscle-invasive bladder cancer compared with observation alone, according to the primary analysis of the IMvigor010 trial reported during the...
“These data are solid, showing a 7-month improvement in overall survival in patients with stable disease or better after first-line chemotherapy. This is roughly a 50% improvement in survival, which is clinically meaningful. Also, progression-free survival was significantly increased with...
According to an interim analysis of the phase III JAVELIN Bladder 100 trial, rates of survival among patients with advanced urothelial carcinoma who did not progress on first-line platinum-based chemotherapy were significantly prolonged by maintenance therapy with avelumab and best supportive care...
The global outbreak of the COVID-19 pandemic forced many cancer societies, including ASCO, to cancel their in-person meetings this year and instead present the latest advancements and new approaches in oncology care via a virtual platform. For the first time in its 56-year history, the ASCO Annual...
On June 30, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. JAVELIN Bladder 100 Efficacy of avelumab...
In patients with metastatic urothelial carcinoma, a novel combination of biomarkers from baseline tumor tissues was predictive of improved clinical responses and prolonged survival following treatment with immune checkpoint inhibitors, according to findings published by Goswami et al in Science...
As reported in the Journal of Clinical Oncology by Vuky et al, 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 metastatic urothelial cancer, with higher response rates and longer survival in...
As reported in The Lancet by Matthew D. Galsky, MD, of Icahn School of Medicine at Mount Sinai, and colleagues, the phase III IMvigor130 trial has shown prolonged progression-free survival with first-line atezolizumab plus platinum-based chemotherapy vs platinum-based chemotherapy alone in patients ...
Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, talks with Thomas Powles, MD, PhD, of Queen Mary University of London, about the first study to demonstrate a survival advantage with avelumab for metastatic urothelial cancer. In the trial, avelumab improved median overall survival by 21.4 months compared with 14.3 months with best supportive care (Abstract LBA1).
“These data are solid, showing a 7-month improvement in overall survival in patients with stable disease or better after first-line chemotherapy. This is roughly a 50% improvement in survival, which is clinically meaningful. Also, progression-free survival was significantly increased with...
Maintenance therapy with avelumab and best supportive care significantly prolonged overall survival vs best supportive care alone in patients with advanced urothelial carcinoma that did not progress on first-line platinum-based chemotherapy, according to an interim analysis of the phase III...
On April 15, 2020, mitomycin gel was approved for the treatment of adult patients with low-grade upper tract urothelial cancer.1,2 Mitomycin gel is for pyelocalyceal use alone and not for intravenous, topical, or oral administration. Supporting Efficacy Data Approval was based on findings in the...
As Thomas Powles, MD, PhD, of Queen Mary University of London, prepares to deliver his late-breaking presentation at the ASCO20 Virtual Scientific Program (LBA-1), he talks with Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, about current therapy: PD1/PDL1 inhibition in second-line treatment and as monotherapy in the first-line setting, as well as the concept of maintenance switch.
Low-intensity cystoscopic surveillance may be a viable option for patients with high-risk, non–muscle invasive bladder cancer, according to data from a paper presented to the media during a special session moderated by the American Urological Association (AUA) on May 15. The research was also...