Photocure: Reduced recurrence after flexible Blue Light Cystoscopy with Hexvix® in surveillance ‒ New Publication of study results

Use of flexible Blue Light Cystoscopy at the first follow-up after TURBT* reduced the risk of tumor recurrence by 33% compared to white light alone. The randomized controlled multi-center study that included 699 bladder cancer patients at 3 hospitals in Denmark is now published in Urology, The Gold Journal. **Oslo, Norway, December 19, 2020**, Photocure ASA (PHO:OSE), is pleased to announce that the results from a new study with Blue Light Cystoscopy (BLC™) with Hexvix and flexible cystoscopes are now published in Urology. Initial study findings had been presented at the annual meeting of the Danish Urology Society on November 16, 2019. 699 patients at 3 hospitals in Denmark were enrolled and randomized 1:1 to either BLC with Hexvix with flexible cystoscopes or white light (WL) only flexible cystoscopy at the time of first follow up after TURBT. Primary endpoint was tumor recurrence within eight months from the randomization. Secondary outcomes were numbers of procedures (TURBTs) in general anesthesia, time to the first recurrence, differences in tumor size, risk of tumor progression, and identification of carcinoma in situ. A total of 351 patients were allocated to the flexible BLC, and 348 to the control group. Throughout the following 8 months after randomization, only 117 patients in the BLC group had at least one tumor recurrence compared to 143 patients in the control group (P= 0.049). Odds ratio of 0.67 (P= 0.02, 95% CI: 0.48-0.95) correlates with a tumor reduction of 33% in favor of the BLC group. “It is very important to Photocure that the scientific community continues to investigate the benefits of our solution for patients,” says Dan Schneider, President and CEO of Photocure. “These first results showing reduced recurrence after flexible Blue Light Cystoscopy with Hexvix in surveillance clearly demonstrate the efficiency of the procedure and show how important it is to include Hexvix in the surveillance and management of NMIBC patients.” The study authors** conclude that use of BLC in the first routine surveillance cystoscopy after TURBT for NMIBC*** reduces subsequent risk of tumor recurrence compared to WL cystoscopy alone. They explain the reduced recurrence rates despite no difference in detection rates at randomization by the possibility of early recurrences arising from small tumors not yet visible at the time of TURBT or residual tumor. They assume that it could be a consequence of the fact that by using BLC-guided flexible cystoscopy, it was possible to detect, and treat, small additional tumors in patients where recurrence was already found at the time of randomization. Link to the study can be found here: https://www.ncbi.nlm.nih.gov/pubmed/31843623 * TURBT: trans-urethral resection of bladder tumors ** Study Authors: Ditte Drejer, Anne-Louise Moltke, Anna Munk Nielsen, Gitte Wrist Lam, Jørgen Bjerggaard Jensen *** NMIBC: non-muscle invasive bladder cancer About Bladder Cancer Bladder cancer ranks as the sixth most common cancer worldwide with 1 650 000 prevalent cases, 550 000 new cases and almost 200 000 deaths annually in 20181. Approx. 75% of all bladder cancer cases occur in men1. It has a high recurrence rate with an average of 61% in year one and 78% over five years2. Bladder cancer has the highest lifetime treatment costs per patient of all cancers3. 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. Incidence/mortality by population. Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx 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. https://www.cancer.org/cancer/bladder-cancer.html About Hexvix®/Cysview® (hexaminolevulinate HCl) Hexvix®/Cysview® is a drug that is selectively taken up by tumor cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). 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 US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Cysview® / Hexvix® directly in the US and the Nordic region and has strategic partnerships for the commercialization of Hexvix® / Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://bit.ly/2wzqSQQ for further information on our commercial partners. 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