FDA Accepts Two sBLAs for Pembrolizumab in Locally Advanced or Metastatic Urothelial Cancer
On February 3, the U.S. Food and Drug Administration (FDA) accepted for review two supplemental Biologics License Applications (sBLAs) for pembrolizumab (Keytruda) in patients with locally advanced or metastatic urothelial cancer. Specifically, the application for first-line use was accepted and...
FDA Approves Nivolumab in Locally Advanced or Metastatic Bladder Cancer
On February 2, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have...
Clinical Trials Actively Recruiting Patients With Bladder Cancer
Phase I Study Title: Ethacrynic Acid Elimination in Nonmuscle Invasive Bladder Cancer Patients Undergoing Transurethral Resection Study Type: Phase I/interventional/single-group assignment Study Sponsor and Collaborators: University of Kansas Medical Center Purpose: To provide quantitative...
Pembrolizumab Studied in Locally Advanced or Metastatic Urothelial Cancer
As reported by Plimack et al in The Lancet Oncology, pembrolizumab (Keytruda) has shown activity in patients in the locally advanced or metastatic urothelial carcinoma cohort included in the phase Ib KEYNOTE-012 trial. Study Details In the study, 33 patients with locally advanced or metastatic...
FDA Accepts sBLA and Grants Priority Review for Atezolizumab in Locally Advanced or Metastatic Urothelial Carcinoma
On January 9, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin...
Survival Benefit Reported With Adjuvant Chemotherapy After Nephroureterectomy for Urothelial Carcinoma
In a National Cancer Database analysis reported in the Journal of Clinical Oncology, Seisen et al found that adjuvant chemotherapy after radical nephroureterectomy was associated with an overall survival benefit in patients with locally advanced or regional lymph node–positive upper tract...
Mutational Characteristics of Chemotherapy-Treated Bladder Urothelial Neoplasms
Radical cystectomy with urinary diversion is the standard of care for muscle invasive bladder cancer.1 Meta-analyses of prospective data have shown a 5% overall survival benefit at 5 years for those receiving neoadjuvant systemic chemotherapy prior to cystectomy.2,3 We currently know of two...
Study Identifies Factors in Clonal Evolution of Chemotherapy-Resistant Urothelial Carcinoma
In a study reported in Nature Genetics, Bishoy M. Faltas, MD, of Weill Cornell Medicine, and colleagues identified factors in the clonal evolution of chemotherapy-resistant urothelial carcinoma.1 As stated by the investigators: “Chemotherapy-resistant urothelial carcinoma has no uniformly curative...
Atezolizumab Shows Activity in First-Line Treatment of Cisplatin-Ineligible Patients With Advanced Urothelial Carcinoma
In a phase II trial reported in The Lancet, Balar et al found that first-line atezolizumab (Tecentriq) produced durable responses in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. In the study, 119 patients from 47 sites in North America and Europe who were ...
Nivolumab in Recurrent Advanced Urothelial Carcinoma
In the phase I/II CheckMate 032 trial reported in The Lancet Oncology, Padmanee Sharma, MD, of The University of Texas MD Anderson Cancer Center, and colleagues found that nivolumab (Opdivo) was active in locally advanced or metastatic urothelial carcinoma progressing after platinum-based therapy....
Anti–PD-1 Contenders in Advanced Urothelial Cancer
Immunotherapy with anti–PD-1 (programmed cell death protein 1) and anti–PD-L1 (programmed cell death ligand 1) agents continues to advance in metastatic urothelial cancer, with positive showings in two clinical trials presented at the 2016 European Society for Medical Oncology (ESMO) Congress. The...
SITC 2016: Immune Checkpoint Inhibitors Shrink Tumors in Some Patients With Metastatic Bladder Cancer
Combination immunotherapy is producing response rates ranging from 26% to 38% among patients with metastatic bladder cancer in the early stages of a three-arm clinical trial presented at the 2016 Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, Maryland. “Until...
Low Vitamin D Levels May Be Linked to Increased Risk of Bladder Cancer
Vitamin D deficiency may be associated with an increased risk of developing bladder cancer, according to a systematic review of seven studies presented at the Society for Endocrinology Annual Conference in Brighton, United Kingdom. Though further clinical studies are needed to confirm the findings, ...
Development and Validation of a Quality Assurance Score for Robot-Assisted Radical Cystectomy
What are the factors that add up to the best outcomes for patients who have surgery to treat cancer? Looking for a better way to measure quality of care and share best practices in surgical oncology, a team from Roswell Park Cancer Institute developed a quality assessment tool and validated it in a ...
KEYNOTE-045 Trial Finds Pembrolizumab Improves Survival Over Chemotherapy in Advanced Urothelial Cancer
The phase III KEYNOTE-045 trial, investigating the use of the anti–PD-1 (programmed cell death protein 1) therapy pembrolizumab (Keytruda) in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival, according to a news release issued by Merck. In...
KEYNOTE-045 Studying Pembrolizumab in Advanced Bladder Cancer Meets Primary Endpoint and Stops Early
Merck announced October 21, 2016, that the phase III KEYNOTE-045 trial investigating the use of pembrolizumab (Keytruda), the company’s anti–PD-1 (programmed cell death protein 1) therapy in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall ...
ESMO 2016: Immunotherapy Shows Promising Results in First- and Second-Line Treatment of Metastatic Bladder Cancer in Two Trials
Immunotherapy has shown promising results in the first- and second-line treatment of metastatic bladder cancer in two phase II trials presented by Galsky et al and Balar et al at the 2016 European Society for Medical Oncology (ESMO) Congress in Copenhagen (Abstracts LBA31_PR and LBA32_PR,...
Sumanta K. Pal, MD, on Urothelial Cancer: Results From the CheckMate 275 Trial
Sumanta K. Pal, MD, of the City of Hope, discusses phase II findings on the efficacy and safety of nivolumab monotherapy in patients with metastatic urothelial cancer who have received prior treatment. Follow him on Twitter: @montypal
Arjun V. Balar, MD, on Urothelial Cancer: Results From KEYNOTE-052
Arjun V. Balar, MD, of the NYU Perlmutter Cancer Center, discusses preliminary phase II study findings on pembrolizumab as first-line therapy for advanced/unresectable or metastatic urothelial cancer. (Abstract LBA32)
High-Intensity Local Treatment in Metastatic Urothelial Carcinoma of the Bladder
In a National Cancer Data Base analysis reported in the Journal of Clinical Oncology, Seisen et al found that high-intensity local treatment was associated with an overall survival benefit in patients with metastatic urothelial carcinoma of the bladder. Quoc-Dien Trinh, MD, of Brigham and Women’s...
Development and Validation of a Quality Assurance Score for Robot-Assisted Radical Cystectomy
What are the factors that add up to the best outcomes for patients who have surgery to treat cancer? Looking for a better way to measure quality of care and share best practices in surgical oncology, a team from Roswell Park Cancer Institute developed a quality assessment tool and validated it in a ...
Multitude of Mentors Help Shape an Illustrious Career in Oncology
Sumanta K. Pal, MD, has had a longer career in oncology than many other colleagues his age. Perhaps the reason for that may center on his starting college at the age 13 and medical school at the age of 17. Today this internationally recognized leader in genitourinary cancers is Assistant Professor ...
Anti–PD-L1 Antibody Durvalumab in Advanced Urothelial Bladder Cancer
In a phase I/II study reported in the Journal of Clinical Oncology, Massard et al found that the anti–PD-L1 (programmed cell death ligand 1) antibody durvalumab was active in patients with previously treated advanced urothelial bladder cancer. Objective response appeared to be confined to patients...
High-Intensity Local Treatment May Improve Survival in Patients With Metastatic Urothelial Carcinoma of the Bladder
In a National Cancer Data Base analysis reported in the Journal of Clinical Oncology, Seisen et al found that high-intensity local treatment was associated with an overall survival benefit in patients with metastatic urothelial carcinoma of the bladder. Study Details The study included data from...
Atezolizumab Promising in Cisplatin-Ineligible Metastatic Bladder Cancer
Atezolizumab (Tecentriq), an anti–programmed cell death ligand 1 (PD-L1) inhibitor, achieved durable responses as first-line treatment in cisplatin-ineligible patients with metastatic urothelial carcinoma in a primary analysis of a phase II trial. These data represent an unmet need, because...
Nivolumab Receives FDA Breakthrough Therapy Designation for Advanced/Metastatic Urothelial Carcinoma
Bristol-Myers Squibb Company announced June 27 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to nivolumab (Opdivo) for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a...
Matching Treatment to Tumor Abnormalities Seems to Pay Off
A strategy of matching molecular abnormalities in patients’ tumors to therapies targeted to those abnormalities is gaining ground, according to preliminary results of the phase IIb MyPathway study presented at the 2016 ASCO Annual Meeting.1 These are still early days for this “matching” strategy,...
Is Anti–PD-L1 Antibody Durvalumab Active in Advanced Urothelial Bladder Cancer?
In a phase I/II study reported in the Journal of Clinical Oncology, Massard et al found that the anti–PD-L1 (programmed cell death ligand 1) antibody durvalumab was active in patients with previously treated advanced urothelial bladder cancer. Objective response appeared to be confined to...
PD-L1 Inhibitor Atezolizumab for Locally Advanced or Metastatic Urothelial Carcinoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.On May 18, 2016, the PD-L1 (programmed cell death ligand 1)...
Atezolizumab in Platinum-Treated Advanced Urothelial Carcinoma: A New Standard of Care?
Compared with a historic control rate, a phase II study of the programmed cell death ligand 1 (PD-L1) inhibitor atezolizumab (Tecentriq) has demonstrated clinically meaningful responses in patients with urothelial carcinoma who progressed after platinum-based chemotherapy.1 Hailed as a “major...
Sumanta K. Pal, MD, and Toni K. Choueiri, MD, on Urothelial Carcinoma: Efficacy of an FGFR Inhibitor
Sumanta K. Pal, MD, of City of Hope, and Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discuss findings on BGJ398 in patients with previously treated advanced/metastatic urothelial carcinoma with FGFR3 alterations (Abstract 4517).
Jonathan E. Rosenberg, MD, and Toni K. Choueiri, MD, on Bladder Cancer: Mutation Burden and Atezolizumab
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, and Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, discuss mutation burden—its role in response to treatment with PD-L1 immunotherapy and its impact on progression-free survival and overall survival, as well as the link between intrinsic expression subtypes and treatment outcome with atezolizumab (Abstract 104).
Arjun Vasant Balar, MD, on Urothelial Carcinoma: Analysis of the IMvigor210 Cohort 1
Arjun Vasant Balar, MD, of the Perlmutter Cancer Center at NYU Langone Medical Center, discusses findings on atezolizumab as first-line therapy in cisplatin-ineligible locally advanced/metastatic disease (Abstract LBA4500).
ASCO 2016: Atezolizumab Benefits Patients With Advanced Bladder Cancer
The anti–programmed cell death ligand 1 (PD-L1) immunotherapy atezolizumab (Tecentriq) is effective in patients with previously untreated advanced bladder cancer who are not eligible for the standard treatment with cisplatin. According to a nonrandomized phase II trial, atezolizumab shrank...
AUA, SUO Release New Clinical Practice Guideline on the Diagnosis and Treatment of Non–Muscle-Invasive Bladder Cancer
The American Urological Association (AUA), together with the Society for Urologic Oncology (SUO), has released a new clinical practice guideline on non–muscle-invasive bladder cancer. This new document outlines guidance on a variety of topics, including diagnosis and treatment, as well as a...
Atezolizumab in Previously Treated Advanced Urothelial Carcinoma
The recent study by Rosenberg et al in The Lancet—summarized in this issue of The ASCO Post—is a very important paper in the field of bladder cancer therapy.1 It is the first phase II trial in metastatic transitional cell carcinoma that demonstrates the single-agent activity of the...
Anti–PD-L1 Antibody Atezolizumab Active in Previously Treated Advanced Urothelial Carcinoma
In a phase II trial reported in The Lancet, Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, and colleagues found that the anti–PD-L1 (programmed cell death ligand 1) antibody atezolizumab produced durable responses in a marked proportion of patients with previously treated...
ASCO and European Association of Urology Agree on Bladder Cancer Guidelines
I like economies of scale, and thus it makes perfect sense that ASCO has set a formal process to allow potential endorsement of selected guidelines from other organizations, rather than redoing the whole process. Recently, we have seen the publication of a formal endorsement of the European...
ASCO Endorses European Association of Urology Guideline on Muscle-Invasive and Metastatic Bladder Cancers
As reported in the Journal of Clinical Oncology by Matthew I. Milowsky, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center, and colleagues,1 ASCO has endorsed the European Association of Urology clinical practice guideline on muscle-invasive and metastatic bladder...
FDA Approves Atezolizumab for Advanced Urothelial Carcinoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to atezolizumab (Tecentriq) for the treatment of urothelial carcinoma, the most common type of bladder cancer. This is the first programmed cell death protein 1/programmed death ligand 1 (PD-1/PD-L1) inhibitor to be...
A Critical Analysis of Early Bladder Cancer Recurrence After Laparoscopic Radical Cystectomy
Although laparoscopic radical cystectomy and robotic-assisted radical cystectomy continue to grow in popularity and are successful in the treatment of bladder cancer, they are still considered experimental approaches. Using data collected by the Section of Uro-Technology of the European Association ...
Phase II Trial Shows Benefit of Adding Ramucirumab to Docetaxel in Previously Treated Advanced Urothelial Carcinoma
Adding the anti–vascular endothelial growth factor receptor 2 (VEGFR-2) antibody ramucirumab to docetaxel improved progression-free survival among previously treated patients with locally advanced or metastatic urothelial carcinoma, reported Petrylak et al in the Journal of Clinical Oncology. ...
Study Finds Adaptive Image-Guided Radiation Therapy for Bladder Preservation Clinically Feasible in Urinary Bladder Cancer
A prospective study examining a trimodality treatment approach in localized bladder cancer cases using adaptive image-guided, intensity-modulated radiation therapy found that the bladder preservation rate at 3 years was 83%. These findings were published by Murthy et al in the International Journal ...
ASCO Endorses European Association of Urology Guideline on Muscle-Invasive and Metastatic Bladder Cancer
As reported in the Journal of Clinical Oncology by Matthew I. Milowsky, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center, and colleagues, ASCO has endorsed the European Association of Urology clinical practice guideline on muscle-invasive and metastatic bladder cancer. ...
MRI-Guided Adaptive Reoptimization in Radiotherapy Shows Promise in Urinary Bladder Cancer Treatment
A new radiotherapy technique could help doctors to focus treatment more precisely on tumors in the bladder and reduce damage to surrounding healthy tissue. Researchers showed that pretreatment imaging using magnetic resonance imaging (MRI) was effective at guiding radiotherapy toward tumors in the...
Atezolizumab Active in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma
The anti–PD-L1 (programmed cell death ligand 1) antibody atezolizumab produced durable responses in a marked proportion of patients with previously treated locally advanced or metastatic urothelial carcinoma, according to a phase II trial reported in The Lancet by Rosenberg et al. The...
Adjuvant Chemoradiotherapy in Locally Advanced Bladder Cancer: Hint of Benefit That Needs Confirmation
Adjuvant sequential chemotherapy plus radiation therapy and adjuvant radiation therapy alone significantly improved local tumor control compared with adjuvant chemotherapy alone in locally advanced bladder cancer but the improvement in disease-free survival (3-year disease-free survival of 68% vs...
Peter E. Clark, MD, on a Guideline Update in the Management of Bladder Cancer
Peter E. Clark, MD, of the Vanderbilt-Ingram Cancer Center discusses the highlights of the 2015 NCCN Guidelines for bladder cancer in both non–muscle invasive and muscle-invasive disease.
Derek Raghavan, MD, PhD: Roundup of Clinical Trial Results on Genitourinary Cancers
Derek Raghavan, MD, PhD, of the Levine Cancer Institute, gives his insights into key genitourinary cancer clinical trials presented at the 2015 ASCO Annual Meeting and his thoughts on where the research is headed.
Jonathan E. Rosenberg, MD, on Results of the IMvigor 210 Study on Atezolizumab in Locally Advanced or Metastatic Urothelial Cancer
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses this pivotal study of an investigational immunotherapy that has shown increased and durable responses, with a relatively benign toxicity profile (Abstract 21LBA).
