Regulatory Filings • Apr 8, 2024
Regulatory Filings
Open in ViewerOpens in native device viewer
European Association of Urology (EAU) 2024 congress features new data on modern technology use in bladder cancer care
Press Release - Oslo, Norway, April 8, 2024: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces its participation in the congress, and two
abstract presentations at the 2024 European Association of Urology congress
(EAU) in Paris, France, highlighting the benefits of Blue Light Cystoscopy
(BLC[®]) in Bladder Cancer management.
The EAU annual meeting is one of the largest international meetings in the
urology calendar, showcasing the latest and most relevant clinical and
scientific advancements in this area of patient care. This year's event was held
on April 5-8, 2024, and attracted urologists from all over the world. Similar to
last year, Photocure will make 2024 EAU bladder cancer session highlights
available to healthcare professionals post event, by means of video interviews
with the presenters of these sessions on the Photocure booth D26. This highly
engaging and successful initiative is once again supported by two of the leading
names in Bladder Cancer in Europe, Prof. M. Rouprêt, APHP, Sorbonne University
Paris, France and Prof. P. Gontero, Division of Urology, University of Studies
of Torino, Italy.
In addition to this educational activity, the EAU scientific program prominently
features Photocure's Hexvix[®] product and/or the blue light cystoscopy
procedure in which it is used. In particular, two notable abstract presentations
were:
Outpatient laser coagulation of low-grade intermediate risk bladder tumor
compared with TUR-BT, 12 months and long-term follow-up of a non-inferiority RCT
(Abstract session 36 NMIBC: Benefits and harms of various treatment options,
Sunday, 7 April, 17:15-18:45)
Treatment of recurrent low grade intermediate risk bladder tumor is burdensome
for patients and health care system. The primary objective of this study was to
evaluate 12 months recurrence-free survival after out-patient department photo
coagulation of bladder tumors (PC-BT) is non-inferior to PDD-assisted TUR-BT in
patients with recurrent Ta low grade bladder tumor. 154 patients were randomized
for PC-BT and 146 for TUR-BT. 12 months follow-up data were available for 299
patients. 12 months recurrence-free survival was 42.2% after PC-BT and 44.1%
after TUR-BT, the difference 1.9% (95%CI -9.3 to 13.2) in favor of TUR-BT.
Regarding 12 months recurrence-free survival, the noninferiority criterion was
met. Recurrence-free survival after OPD PC-BT is noninferior to TUR-BT at 12
months follow-up. Incidence of long-term stage progression after PC-BT is
noninferior to TUR-BT and very low after both treatment modalities. Treatment of
recurrent Ta low grade intermediate risk bladder tumors in out-patient
department with PC-BT appears to be a safe alternative to TUR-BT.
Read the abstract: https://urosource.uroweb.org/resource
-centres/EAU24/257251/abstract
A prospective, comparative, within-patient controlled multicenter phase III
study comparing blue light cystoscopy versus white light cystoscopy for the
detection of bladder cancer using modern HD 4K equipment (Abstract session 46,
Monday, 8 April, 12:30-14:00)
The study enrolled a total of 158 patients in a randomized controlled trial, and
114 patients underwent Hexvix blue light cystoscopy (BLC) and were in the full
analysis set. Among patients diagnosed with Ta, T1, or CIS, 42 out of 97
patients (43.3%) had at least one lesion detected by BLC but not by white light
cystoscopy (WLC) (p<0.0001). Thirteen patients had CIS of which 11 (84.6%)
showed additional CIS lesions. The BLC detection rates for PUNLMP, CIS, Ta, T1,
and T2 ~ T4 tumors were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while
the WLC detection rates were NA, 42.1%, 76.1%, 91.2%, and 100%. This study
confirms the superiority of HAL BLC over WLC in the detection of bladder cancer
even if improved WLC using HD 4K equipment is utilized. In particular,
additional high-risk difficult to see CIS lesions have been identified in 85% of
all CIS patients only by HAL BLC. The quality of resection is still a key
cornerstone in the treatment of NMIBC of which BLC remains a crucial part
despite the further development of WLC imaging.
Read the abstract: https://urosource.uroweb.org/resource
-centres/EAU24/257159/abstract
"With the rapid advancement of technologies, emerging trends towards precision
medicine and introduction of novel targeted agents which are transforming
bladder cancer care, there is a renewed emphasis on the importance of the
diagnostic process. Getting a correct and timely diagnosis is more important
than ever. It's key to optimizing the subsequent care pathways and treatment
decisions," said Anders Neijber, Chief Medical Officer of Photocure. "These new
results presented at EAU continue to emphasize the importance of using Blue
Light Cystoscopy in the diagnosis of bladder cancer. BLC has been shown to
clinically increase TURBT quality, more accurately stage disease, and enable
better recurrence monitoring, supporting the long-term utility to help improve
the lives of patients with bladder cancer."
"Every year we see new data added to the body of evidence on Hexvix/blue light
cystoscopy benefits, including with high-definition equipment. In Europe, our
teams focus on helping their customers achieve the best possible image quality
for BLC. We are convinced that when it comes to bladder tumor detection methods
"seeing is believing", which is also our booth theme for this year's EAU. Many
urologists try BLC, see what they see, and never look back", added Susanne
Strauss, Vice President and General Manager Europe.
*TUR-BT/TURBT: trans-urethral resection of bladder tumors
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 8[th] most common cancer worldwide - the 5[th] most
common in men - with 1 949 000 prevalent cases (5-year prevalence rate)[1a],
614 000 new cases and more than 220 000 deaths in 2022.[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 [February 2024].
[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]
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.