Evidence map›Paper›PMID 38704840›Full record

Trial reportThe Journal of urology2024

Efficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin-Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial.

Vikram M Narayan, Stephen A Boorjian, Mehrdad Alemozaffar, Badrinath R Konety, Neal D Shore, Leonard G Gomella, Ashish M Kamat, Trinity J Bivalacqua, Jeffrey S Montgomery, Seth P Lerner and 30 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of urology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 52 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02773849 phase3completednot on this map

A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-IFN)/Syn3) Administered Intravesically to Patients With High-Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

TypeinterventionalSponsorFerring PharmaceuticalsRan2016 to 2023Enrolled157ConditionsSuperficial Bladder CancerArmsADSTILADRIN
NCT07322263 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Intravesical Gemcitabine and Docetaxel for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: A Prospective Cohort Study (GEMDOCE-BU)

TypeinterventionalSponsorMichael A. O'DonnellRan2026 to 2033Enrolled174ConditionsBladder Cancer, Non-Muscle Invasive Bladder Cancer (NMIBC), Urothelial Carcinoma, Carcinoma in Situ (CIS)ArmsIntravesical Gemcitabine and Docetaxel
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. TAR-200 for Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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  18. [Treatment of non-muscle-invasive bladder cancer].Urologie (Heidelberg, Germany) · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

40 authors.

Vikram M NarayanDepartment of Urology, Emory University School of Medicine, Atlanta, Georgia.ORCID 0000-0003-3731-4209
Stephen A BoorjianDepartment of Urology, Mayo Clinic, Rochester, Minnesota.
Mehrdad AlemozaffarDepartment of Urology, Southern California Permanente Medical Group, Los Angeles, California.
Badrinath R KonetyDepartment of Urology, University of Minnesota and Allina Health Cancer Institute, Minneapolis, Minnesota.
Neal D ShoreCarolina Urologic Research Center, Myrtle Beach, South Carolina.
Leonard G GomellaDepartment of Urology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania.
Ashish M KamatDepartment of Urology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Trinity J BivalacquaDivision of Urology, Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
Jeffrey S MontgomeryDepartment of Urology, University of Michigan, Ann Arbor, Michigan.
Seth P LernerScott Department of Urology, Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, Texas.
Joseph E BusbyCancer Centers of the Carolinas, Greenville Hospital System, Greenville, South Carolina.
Michael PochDepartment of GU Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida.
Paul L CrispenDepartment of Urology, University of Florida, Gainesville, Florida.
Gary D SteinbergDepartment of Urology, Rush University, Chicago, Illinois.
Anne K SchuckmanUSC Institute of Urology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California.
Tracy M DownsDepartment of Urology, University of Virginia, Charlottesville, Virginia.
Joseph MashniBanner MD Anderson Cancer Center, Gilbert, Arizona.
Brian R LaneDivision of Urology, Spectrum Health, Michigan State University College of Human Medicine, Grand Rapids, Michigan.
Thomas J GuzzoDivision of Urology, Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
Gennady BratslavskyDepartment of Urology, SUNY Upstate Medical University, Syracuse, New York.
Lawrence I KarshThe Urology Center of Colorado, Denver, Colorado.
Michael E WoodsDepartment of Urology, Loyola University Medical Center, Maywood, Illinois.
Gordon BrownNew Jersey Urology, Bloomfield, New Jersey.
Daniel CanterGeorgia Urology, Atlanta, Georgia.
Adam LucheyWest Virginia University Cancer Institute, Morgantown, West Virginia.
Yair LotanDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, Texas.
Brant A InmanDivision of Urology, Department of Surgery, Western University, London, Ontario, Canada.
Michael B WilliamsUrology of Virginia, Virginia Beach, Virginia.
Michael S CooksonDepartment of Urology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.
Sam S ChangDepartment of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.
Alexander I SankinDepartment of Urology, Montefiore Medical Center, Bronx, New York.
Michael A O'DonnellDepartment of Urology, University of Iowa, Iowa City, Iowa.
David SawutzFKD Therapies Oy, Kuopio, Finland.
Richard PhilipsonCalliditas Therapeutics, Stockholm, Sweden.
Nigel R ParkerAI Virtanen Institute University of Eastern Finland and Science Service Center and Gene Therapy Unit, Kuopio, Finland.
Seppo Yla-HerttualaAI Virtanen Institute University of Eastern Finland and Science Service Center and Gene Therapy Unit, Kuopio, Finland.
Dorte RehmFerring Pharmaceuticals A/S, Copenhagen, Denmark.
Jørn S JakobsenFerring Pharmaceuticals A/S, Copenhagen, Denmark.
Kristian JuulFerring Pharmaceuticals A/S, Copenhagen, Denmark.
Colin P N DinneyDepartment of Urology, University of Texas MD Anderson Cancer Center, Houston, Texas.

Funding

Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Christopher K Laubenthal · 2000 to 2026
$70.0M
NCI NIH HHS P30 CA086862
6 · The paper itself

Abstract

purposeNadofaragene firadenovec-vncg is a nonreplicating adenoviral vector-based gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive carcinoma in situ (CIS) with/without high-grade Ta/T1. We report outcomes following 5 years of planned follow-up. MATERIALS AND

methodsThis open-label phase 3 trial (NCT02773849) enrolled patients with BCG-unresponsive nonmuscle-invasive bladder cancer in 2 cohorts: CIS ± Ta/T1 (CIS; n = 107) and Ta/T1 without CIS (Ta/T1 cohort; n = 50). Patients received 75 mL (3 × 10

resultsOne hundred fifty-seven patients were enrolled from 33 US sites (n = 151 included in efficacy analyses). Median follow-up was 50.8 months (interquartile range 39.1-60.0), with 27% receiving ≥ 5 instillations and 7.6% receiving treatment for ≥ 57 months. Of patients with CIS 5.8% (95% CI 2.2-12.2) were HGRF at month 57, and 15% (95% CI 6.1-27.8) of patients with high-grade Ta/T1 were HGRF at month 57. Kaplan-Meier-estimated HGRF survival at 57 months was 13% (95% CI 6.9-21.5) and 33% (95% CI 19.5-46.6) in the CIS and Ta/T1 cohorts, respectively. Cystectomy-free survival at month 60 was 49% (95% CI 40.0-57.1): 43% (95% CI 32.2-53.7) in the CIS cohort and 59% (95% CI 43.1-71.4) in the Ta/T1 cohort. Overall survival at 60 months was 80% (71.0, 86.0): 76% (64.6-84.5) and 86% (70.9-93.5) in the CIS and Ta/T1 cohorts, respectively. Only 5 patients (4 with CIS and 1 with Ta/T1) experienced clinical progression to muscle-invasive disease.

conclusionsAt 60 months, nadofaragene firadenovec-vncg allowed bladder preservation in nearly half of the patients and proved to be a safe option for BCG-unresponsive nonmuscle-invasive bladder cancer.

Indexed as

BCG VaccineUrinary Bladder NeoplasmsAdenoviridaeAdjuvants, ImmunologicAdministration, IntravesicalAgedAged, 80 and overCarcinoma in SituFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm InvasivenessTreatment OutcomeAdjuvants, ImmunologicBCG VaccineBCG-unresponsive bladder cancerbladder cancergene therapyintravesical instillationnonmuscle invasive bladder cancer

Identifiers

PMID38704840
PMCPMC12721637

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.