Regulatory Filings • Dec 1, 2023
Regulatory Filings
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SUO 2023 Meeting: New Real World Evidence shows Significant Decrease in Risk of Bladder Cancer Recurrence with Blue Light Cystoscopy
Press release - Oslo, Norway, December 1, 2023: Photocure ASA (OSE: PHO), The
Bladder Cancer Company, announces that new evidence from routine clinical
practice in the Veterans Affairs (VA) healthcare system was presented at the
24[th] Annual Society of Urologic Oncology (SUO) meeting demonstrating a
significantly reduced risk of tumor recurrence (33%) in non-muscle invasive
bladder cancer (NMIBC) patients who received Blue Light Cystoscopy (BLC[®])
compared to patients who only underwent standard White Light Cystoscopy (WLC).
The abstract and Poster entitled "Comparing white light versus blue light
cystoscopy recurrence outcomes among non-muscle invasive bladder cancer patients
in an equal access setting: a propensity scored matched analysis" was presented
on Thursday, November 30, by Sanjay Das, MD. The data presented stemmed from
data in patients treated within the Veteran Affairs Healthcare System (VA HCS)
that underwent BLC or WLC for NMIBC.*
Methodology: a total of 337 BLC recipients were first identified and compared to
337 WLC recipients using 1:1 propensity score matching. The cohorts
predominantly were high-grade patients (64%) treated with the current standard
of care, including adequate BCG treatment when appropriate. The study used the
Kaplan-Meier method to estimate event-free survival and Cox regression to
determine the association between the type of cystoscopy (BLC vs. WLC) and
recurrence.
The authors concluded that overall, the risk of recurrence was significantly
lower following use of BLC (Hazard Ratio 0.67; p-value: 0.006) compared to WLC
alone. Furthermore, there were no statistically significant changes in
recurrence based on racial stratification, suggesting that the equal access
nature of the VA provides best standard of care.
"This multi-phased study shows Photocure's commitment to support the evaluation
of long-term clinical utility, cost effectiveness of BLC technology, and
addressing disparities in the care of NMIBC using real world evidence (RWE).
Going forward we expect further valuable insights through RWE analyses in
collaboration with the Veterans Affairs Healthcare System", said Anders Neijber,
Photocure's Chief Medical Officer.
The data were presented at the Annual Meeting of the Society of Urologic
Oncology (SUO) meeting held November 30 - December 2, 2023, in Washington DC,
USA.
Read the abstract here:
https://suo-abstracts.secure-platform.com/a/gallery/rounds/18/details/2898
*NMIBC: non-muscle-invasive bladder cancer
Note to editors:
All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.
This press release may contain product details and information which are not
valid, or a product 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 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 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: 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: [email protected]
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: [email protected]
David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: [email protected]
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]
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