Clinical data presented at ASCO GU demonstrates reduced risk of recurrence in non-muscle invasive bladder cancer with the use of BLC

20 Feb 2023 07:30 CET

Press release - Oslo, Norway, February 20, 2023: Photocure ASA, The Bladder
Cancer Company, announces the presentation of clinical data from the Veterans
Affairs (VA) BRAVO study at the ASCO Genitourinary Cancers Symposium (ASCO GU)
which was held February 16-18, 2023 in San Francisco, USA. The clinical data
demonstrated a significant decrease in the risk of recurrence & longer time to
recurrence following Blue Light cystoscopy (BLC[®]) with Cysview[®] compared to
White Light cystoscopy (WLC) alone.

ASCO GU is a meeting of up to 5 000 healthcare professionals focused on
genitourinary cancers, offering the latest information on scientific advances in
the study, diagnosis and treatment of GU malignancies. The program is known for
being highly interactive with multidisciplinary perspectives and attracts a
global audience. Presentations include the latest science and evidence-based
information on optimal patient care.

Dr. Steven Williams, University of Texas-Medical Branch, Galveston, presented
the study abstract "The Impact of Blue Light Cystoscopy Use Among Non-Muscle
Invasive Bladder Cancer Patients in an Equal Access Setting: Implications on
Recurrence and Time to Recurrence Stratified by Race".

The study was conducted with support from Photocure and aims to describe bladder
cancer outcomes and the impact of blue light cystoscopy (BLC®) with Cysview®
among non-muscle invasive bladder cancer (NMIBC) patients in an equal access
setting, i.e., the United States Veterans Affairs Healthcare System (VA).
Patients diagnosed with NMIBC within the VA who received BLC were assessed to
determine overall recurrence rates as well as the association between race and
recurrence, progression, and overall survival outcomes.

A total of 378 patients were included in the analysis, of which 43 (11%) were
African American and 300 (79%) were Caucasian. The results showed that the
median time to first recurrence following BLC vs. WLC was significantly longer
overall (40 vs. 26 months, p<0.001) and across all time points, respectively, in
the cohort. A significant decrease in risk of recurrence following BLC
utilization compared to WLC alone was also determined (HR, 0.70, p=0.005). With
regard to race stratification, the analysis showed no significant difference
between African American and Caucasian patients for recurrence, progression and
overall survival.

"Our findings demonstrate increased support for blue light cystoscopy's clinical
role in reducing bladder cancer recurrence, and that equal access to health care
can achieve equitable outcomes. These data support current AUA/SUO guidelines
recommending BLC usage in patients with NMIBC to increase detection and decrease
recurrence." said Dr. Steven Williams, Professor and Chief of the Division of
Urology, at the University of Texas-Medical Branch, and one of the study
authors.

*Read about the abstract: https://meetings.asco.org/abstracts
-presentations/216732

Note to editors

Hexvix[®]/Cysview[®] and BLC[®] are registered trademarks of Photocure ASA.
This press release may contain product details and information which are not
valid, or a product that is not accessible, in your country. Please be aware
that Photocure does not take any responsibility for accessing such information,
which may not comply with any legal process, regulation, registration, or usage
in the country of your origin.

About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide - the 5th most
common in men - 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 up to 61% in year one and up to 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 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: https://gco.iarc.fr/today, accessed [January 2022].
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 preferentially accumulates in cancer cells in the
bladder, making them glow bright pink during Blue Light Cystoscopy (BLC[®]). BLC
with Hexvix/Cysview, compared to standard white light cystoscopy alone, 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, Chile, Australia, New Zealand and Israel. Please refer
to https://photocure.com/partners/our-partners for further information on our
commercial partners.

About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com, www.cysview.com

For further information, please contact:

Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com

David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: david.moskowitz@photocure.com

Media and IR enquiries:

Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no

More information:
Access the news on Oslo Bors NewsWeb site

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