On September 15, 2021 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported a clinical data presentation and highlights from the 2021 American Urological Association Annual Congress (AUA2021), which was held virtually September 10-13, 2021 (Press release, PhotoCure, SEP 15, 2021, View Source [SID1234587785]). During the program, new results from a study using Blue Light Cystoscopy (BLC) with Cysview in the surveillance setting were reported in a podium presentation, and separately, BLC with Cysview was discussed in an Expert Presentation on Surgical Techniques.
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The American Urological Association (AUA) meeting is one of largest international meetings in the urology calendar. This year’s event included an innovative, evidence-based, quality program for urologists and urologic health care professionals worldwide.
Podium Presentation
Title: UTILITY OF BLUE LIGHT FLEXIBLE CYSTOSCOPY FOR BLADDER CANCER SURVEILLANCE AFTER INTRAVESICAL THERAPY
Presenter: Sanam Ladi Seyedian, M.D., University of Southern California
Session and Date: PD-63: Bladder: Cancer Non-Invasive III: Sept. 13, 2021
Results were provided by two high-volume treatment facilities that perform Blue Light Flexible Cystoscopy (BLFC) and are participants in the Blue Light Cystoscopy with Cysview Registry. In this study, data was captured from 277 office based BLFC examinations in 136 patients who received intravesical BCG or chemotherapy, as part of standard of care treatment for non-muscle invasive bladder cancer (NMIBC).
From these examinations, a total of 52 office-based biopsies were taken, of which 23 (44%) were confirmed as malignant. BLFC identified all 23 malignancies, demonstrating 100% sensitivity for cancer detection in this cohort, whereas analysis by cytology identified only 3 of the 23 confirmed malignancies. Additionally, from the 277 total examinations, 23 (8%) were White Light Cystoscopy (WLC) normal and BLFC abnormal. Of these 23 discordant results, 16 had office-based biopsies and cancer was confirmed in 9 cases (56%), which would have been missed by WLC alone.
The study authors concluded that office-based BLFC helps improve early detection of recurrence in cases with normal WLC and can aid in surveillance of patients receiving intravesical therapy, enhance performance of office-based biopsy and increase early detection of BCG unresponsive disease.
"The results from this study show that use of Blue Light Cystoscopy with Cysview for patient surveillance improved the ability to detect recurrent disease in this high-risk, recently-treated patient cohort, which can significantly impact future treatment decisions," said Dr. Sia Daneshmand, one of the study authors. "Early detection of recurrent or residual cancer during initial treatment is essential for properly risk-stratifying all bladder cancer patients, and confirming response to treatment on follow-up and can have a major impact on subsequent treatment pathways and patient outcomes. As a result, Blue Light Cystoscopy can be an important tool throughout the continuum of care for patients diagnosed with bladder cancer."
Dr. Sia Daneshmand, M.D., is a Professor of Urology with Clinical Scholar designation and serves as director of clinical research as well as the urologic oncology (SUO) fellowship director at the University of Southern California (USC) in Los Angeles.
Abstract Link: View Source
Expert Presentation
Title: ADVANCES IN ENDOSCOPIC TREATMENT OF BLADDER TUMORS
Presenter: Yair Lotan, M.D., UT Southwestern Medical Center
Session and Date: Plenary Session: Surgical Techniques: Sept. 10, 2021
In this presentation, Dr. Lotan emphasized the importance of BLC with Cysview in accurately detecting NMIBC, stratifying bladder tumors, and helping to perform a complete TURBT in the operating room. He also provided an expert perspective on how biopsy and fulguration in the surveillance setting can positively impact patient outcomes using BLC with Cysview in the office-based setting.
Dr. Lotan is a Professor of the Department of Urology at UT Southwestern and Jane and John Justin Distinguished Chair in Urology, In Honor of Claus G. Roehrborn, M.D. He is Vice chair of Clinical Affairs and chief of urologic oncology.
"The study results presented at this year’s AUA meeting as well as the discussion on BLC in the Surgical Techniques presentation underscores how critically important it is for patients to receive the proper bladder cancer care whether they are having tumor resection in the hospital or follow-up procedures" said Geoffrey Coy, Vice President and General Manager of North American Operations at Photocure. "These new study results also highlight the range of opportunities made possible by Blue Light Cystoscopy for urologists, and the benefits to patients, especially when including flexible Blue Light Cystoscopy in the office setting as part of the continuum of care. We remain focused on expanding the availability of the procedure so that more physicians and patients have access to this important solution."
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About Bladder Cancer
Bladder cancer ranks as the seventh most common cancer worldwide with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3, and T4, are more likely to spread and are harder to treat.4
1 Globocan. a) 5-year prevalence / b) incidence/mortality by population.
Available at: View Source, accessed [April 2021].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. View Source
About Hexvix/Cysview (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Canada, Chile, Australia, and New Zealand. Please refer to View Source for further information on our commercial partners.