Safety, Tolerability, and Preliminary Efficacy of TAR-200 in Patients With Muscle-invasive Bladder Cancer Who Refused or Were Unfit for Curative-intent Therapy: A Phase 1 Study

Tyson, Mark D.; Morris, David; Palou, Juan; Rodríguez, Ó.; Mir, Maria Carmen; Dickstein, Rian J.; Guerrero-Ramos, F.; Scarpato, Kristen R.; Hafron, Jason; Messing, Edward M.; Cutie, Christopher; Maffeo, John; Raybold, Bradley; Chau, Albert; Stromberg, Katharine A; Keegan, Kirk A.

doi:10.1097/ju.0000000000003195

Cited by 8 publications

(2 citation statements)

References 30 publications

(48 reference statements)

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“…A recently published study reported on the safety and preliminary efficacy of TAR-200 in patients with muscle-invasive bladder cancer (MIBC) [36]. Patients were given 4 cycles of TAR 200 used in 21-day cycles within a week of maximal transurethral resection of bladder tumour (TURBT), followed by three single quarterly cycles.…”

Section: New Developments and Future Directionsmentioning

confidence: 99%

The Utility of Intraluminal Therapies in Upper Tract Urothelial Carcinoma: A Narrative Review

Tyrrell,

Chui,

Kealey

et al. 2024

Cancers

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Nephron sparing surgery (NSS) is considered for selected cases of upper tract urothelial carcinoma (UTUC) as it maintains renal function and avoids morbidity associated with radical nephroureterectomy (RNU). The appropriate selection of patients suitable for NSS without compromising oncological outcomes can sometimes be difficult, given the limitations of diagnostic modalities. Recurrence rates for UTUC can be as high as 36 to 54% after NSS. Intraluminal adjuvant therapy can be attempted following NSS to reduce recurrence, but delivery to the upper tract is more challenging than into the bladder. Bacillus Calmette-Guerin (BCG) and chemotherapy such as Mitomycin (MMC) have been administered via nephrostomy or ureteric catheter, which requires invasive/repeated instrumentation of the upper urinary tract. Drug delivery by reflux from bladder instillation along indwelling stents has also been tried but can potentially be unreliable. Recently, a gel formulation of mitomycin has been developed for the controlled exposure of the upper urinary tract to treatment over a number of hours. Drug-eluting stents to deliver chemotherapy to the upper urinary tract have been developed but have not yet entered clinical practice. Endoluminal phototherapy utilising an intravenous photosensitising agent is another novel approach that has recently been described. Intraluminal therapies may be beneficial in decreasing recurrence rates in UTUC, but currently have some limitations in their usage.

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Section: New Developments and Future Directionsmentioning

confidence: 99%

The Utility of Intraluminal Therapies in Upper Tract Urothelial Carcinoma: A Narrative Review

Tyrrell,

Chui,

Kealey

et al. 2024

Cancers

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“…Pembrolizumab, in the Keynote 057 single armed trial, had a three month CR rate of 38% and a two-year recurrence free survival rate of 15% [ 6 ] and also is FDA approved for this clinical scenario. While there are numerous agents in testing, including intravesical instillations of Coxsackievirus A21 [ 7 ] and a gemcitabine impregnated device placed in the bladder (TAR 200) [ 8 ], none are available currently and are unlikely to be until ongoing trials are completed.…”

mentioning

confidence: 99%

Salvage for BCG Unresponsive and Recurrent Disease

Messing

2021

BLC

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So what does the patient with high grade, nonmuscle invasive bladder cancer who has disease that is unresponsive to (or has quickly recurred after) adequate intravesical therapy with Bacillus Calmette Guerin (BCG) do, particularly if he (she) does not want to lose his (her) bladder? Two agents that received priority, fast track priority review by the Food and Drug Administration (FDA) for such patients, Vicinuim [1] and Nadofaragene (rAd-If Na/Syn 3) [2], which have efficacy in this circumstance have experienced production problems and are not available [3,4]. In a non-randomized (single arm) phase 3 study, Vicinium, an antibody to the transmembrane cell adhesion molecule, EpCam, conjugated to Pseudomonas exotoxin A (which stops protein translation and induces apoptosis) there was a complete response (CR) rate of 39% at three months and 17% at 12 months [1], while Nadofaragene, an adenovirus mediated "gene therapy" producing interferon alpha [2] had 53% CRs at 3 months and 45% at 12 months in another single arm phase 3 study.This leaves intravesical chemotherapy with one or two agents (usually gemcitabine and/or docetaxel) [5] or other drugs (e.g. mitomycin C or valrubicin), or intravenous infusions of Pembrolizumab (an anti-PD-1 antibody) [6] for these patients.

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The Safety, Tolerability, and Preliminary Efficacy of a Gemcitabine-releasing Intravesical System (TAR-200) in American Urological Association–defined Intermediate-risk Non–muscle-invasive Bladder Cancer Patients: A Phase 1b Study

P. van Valenberg,

van der Heijden,

Cutie

et al. 2024

European Urology Open Science

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Safety, Tolerability, and Preliminary Efficacy of TAR-200 in Patients With Muscle-invasive Bladder Cancer Who Refused or Were Unfit for Curative-intent Therapy: A Phase 1 Study

Cited by 8 publications

References 30 publications

The Utility of Intraluminal Therapies in Upper Tract Urothelial Carcinoma: A Narrative Review

The Utility of Intraluminal Therapies in Upper Tract Urothelial Carcinoma: A Narrative Review

Salvage for BCG Unresponsive and Recurrent Disease

The Safety, Tolerability, and Preliminary Efficacy of a Gemcitabine-releasing Intravesical System (TAR-200) in American Urological Association–defined Intermediate-risk Non–muscle-invasive Bladder Cancer Patients: A Phase 1b Study

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