POD-07.03: Treatment With Intravesical Vicinium™ Results in Durable Responses in Patients with Carcinoma In Situ (CIS) Previously Treated with Bacille Calmette-Guérin (BCG)

Kowalski, Mark; Jones, Noleen; Jewett, Michael; Cuthbert, W.

doi:10.1016/j.urology.2009.07.1142

Cited by 5 publications

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“…40% of patients with Tis and 71% of patients with Ta/T1 disease remained disease free at three months ( 67 ). In a similar trial of 22 patients treated with six-week course of weekly vicinium (up to 30 mg), 41% had CR at 3 months ( 68 ). In 2021, the U.S Food and Drug Administration denied the approval of intravesical vicinium for the treatment of NMIBC ( 69 ).…”

Section: Resultsmentioning

confidence: 99%

“…Vicinium is selective for EpCAM-positive BCa cells; with such a targeted mechanism of action, AEs should be limited ( 67 ). Also, due to its small molecular weight, almost all vicinium remains within the bladder following intravesical administration ( 68 , 70 ), hence AEs tend to be localised and mild (grade 1–2); nevertheless, AEs have been reported in up to 52% of patients ( 67 , 71 ).…”

Section: Resultsmentioning

confidence: 99%

“…Results of early-stage clinical trials are also promising for “targeted” therapies including immune checkpoint inhibitors and monoclonal antibodies. The selectivity of these drugs should minimise their toxicity and side-effects ( 52 – 54 , 56 , 59 , 68 ). Chemohyperthermia and hydrogels are promising and may enhance the clinical efficacy of intravesical MMC delivery ( 107 , 122 ); with international BCG supply issues, improving MMC efficacy may be particularly important for patients with intermediate- and high-risk NMIBC ( 125 ).…”

Section: Discussionmentioning

confidence: 99%

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Novel intravesical therapeutics in the treatment of non-muscle invasive bladder cancer: Horizon scanning

et al. 2022

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IntroductionNon-muscle-invasive bladder cancer (NMIBC) is a common and heterogeneous disease; many patients develop recurrent or progress to muscle-invasive disease. Intravesical drug therapy is a pillar in the current management of NMIBC; notwithstanding, Mitomycin C (MMC) and Bacillus Calmette-Guérin (BCG) have numerous limitations including international supply issues, and local and systemic toxicity. Here we review novel intravesical therapeutic options and drug delivery devices with potential for clinical use in the treatment of NMIBC.MethodsPubMed, ClinicalTrials.gov and Cochrane Library searches were undertaken. Systematic reviews, meta-analyses, randomised controlled trials, single-arm clinical trials and national/international conference proceedings were included.ResultsNovel intravesical drugs, including chemotherapeutic agents, immune checkpoint inhibitors, monoclonal antibodies and gene therapies, have demonstrated varying efficacy in the treatment of NMIBC. Current evidence for the majority of treatments is mostly limited to single-arm trials in patients with recurrent NMIBC. Various novel methods of drug delivery have also been investigated, with encouraging preliminary results supporting the intravesical delivery of hyperthermic MMC and MMC hydrogel formulations.ConclusionsNovel therapeutic agents and drug delivery systems will be important in the future intravesical management of NMIBC. As our understanding of the molecular diversity of NMIBC develops, molecular subtyping will become fundamental in the personalisation of intravesical treatments. Further randomised studies are urgently required to investigate the efficacy of novel intravesical treatments and novel regimens, in comparison to current standards-of-care, particularly in the context of international BCG shortages.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Novel intravesical therapeutics in the treatment of non-muscle invasive bladder cancer: Horizon scanning

et al. 2022

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“…Data from 46 BCG-refractory or -intolerant patients with CIS of the bladder have been released. 47 The first 23 patients received Vicinium weekly for 6 weeks. At 3 months, patients with disease <T2 received a repeat induction course, whereas patients free of disease received maintenance doses weekly for 3 weeks at 3-month intervals.…”

Section: Immunotherapy and New Conservative Treatment Avenues Followimentioning

confidence: 99%

The management of BCG failure in non-muscle-invasive bladder cancer: an update

Zlotta

Fleshner

Jewett

2013

CUAJ

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Up to 40% of patients with non-muscle-invasive bladder cancer (NMIBC) will fail intravesical bacillus Calmette-Guérin (BCG) therapy. There is unfortunately no current gold standard for salvage intravesical therapy after appropriate BCG treatment. Indeed, outcomes are at best suboptimal. The vast majority of low-grade NMIBC are prone to recur but very rarely progress. Failure after intravesical BCG in these patients is usually superficial and lowgrade. At the other end of the spectrum, failure to respond to BCG in high-risk T1 bladder cancer and/or carcinoma in situ (CIS or TIS) is more problematic, since those tumours often have the potential to progress to muscle invasion. In these cases, radical cystectomy remains the mainstay after BCG failure. With appropriate selection, certain patients who "fail" BCG (but with favourable risk factors) can be managed with intravesical regimens, including repeated BCG, BCG plus cytokines, intravesical chemotherapy, thermochemotherapy or new immunotherapeutic modalities. In this review, reasons explaining BCG failure, how to define BCG failure, optimal risk stratification and prediction of response and management of BCG failures are discussed.

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“…Of the patients receiving the 6-week induction regimen, 41% (9/22), 32% (6/19), and 16% (3/19) showed complete response at 3, 6, and 12 months, respectively. Of the patients receiving the 12-week induction regimen, 39% (9/23) had complete response at 3 months [45].…”

Section: Viciniummentioning

confidence: 99%

Recognition and Treatment of BCG Failure in Bladder Cancer

Lightfoot

Rosevear

O’Donnell

2011

The Scientific World JOURNAL

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Patients with high-grade Ta, T1, or carcinoma in situ non–muscle-invasive bladder cancer (NMIBC) are at high risk for recurrence and, more importantly, progression. Thus, both the American Urological Association and European Association of Urology recommend initial intravesical treatment with bacillus Calmette-Guerin(BCG) followed by maintenance therapy for a minimum of 1 year. The complete response rate to BCG therapy in patients with high-risk NMIBC can be as high as ∼80%; however, most patients with high-risk disease suffer from recurrence. BCG failure can be further characterized into BCG refractory, BCG resistant, BCG relapsing, and BCG intolerant. Current recommendations include one further course of BCG or cystectomy. In patients who continue to fail conservative treatment and who refuse surgical therapy or are not surgical candidates, treatment options become even more complicated. In this setting, treatment options are limited and include repeat BCG treatment, an alternate immunotherapy regimen, chemotherapy, or device-assisted therapy. To date, however, further research is necessary for all secondary treatment options in order to determine which might be the most efficacious. All conservative treatments should be considered investigational. Currently, cystectomy remains the standard of care for high-risk patients who have failed BCG therapy.

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POD-07.03: Treatment With Intravesical Vicinium™ Results in Durable Responses in Patients with Carcinoma In Situ (CIS) Previously Treated with Bacille Calmette-Guérin (BCG)

Cited by 5 publications

References 0 publications

Novel intravesical therapeutics in the treatment of non-muscle invasive bladder cancer: Horizon scanning

Novel intravesical therapeutics in the treatment of non-muscle invasive bladder cancer: Horizon scanning

The management of BCG failure in non-muscle-invasive bladder cancer: an update

Recognition and Treatment of BCG Failure in Bladder Cancer

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