Press Release - Oslo, Norway, March 16, 2026: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces two "trial in progress" presentations at the
2026 European Association of Urology congress (EAU) in London, UK. These trials
investigate different stages of the diagnostic pathway, addressing data gaps to
improve individual patient care and outcomes.
The EAU annual meeting is one of the largest international meetings in the
global urology calendar, showcasing the latest and most relevant clinical and
scientific advancements in this area of patient care.
Photocure participated with its Hexvix[®] product, designed for better detection
and resection of bladder tumors. As in past sessions and as a service to non
-attending urologists, Photocure will make 2026 EAU bladder cancer session
highlights available to healthcare professionals after the event, by means of
video interviews with the presenters of these sessions at the Photocure booth.
This 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
featured Photocure's Hexvix product and/or the blue light cystoscopy procedure
in which it is used. In particular, two notable bladder cancer "trial in
progress" presentations from Monday, March 16, 2026 were:
A0648: VI-RADS & PDD-TURBT to avoid Second-look and Resection (Re-TURBT) in Non
-Muscle Invasive Bladder Cancers: The CUT-less Randomized Clinical Trial
F. Del Giudice, Rome (IT)
The CUT-less trial investigates whether second-look TURB can be safely omitted
by combining preoperative staging accuracy of Magnetic Resonance Imaging (MRI)
using the Vesical Imaging-Reporting and Data System (VI-RADS) with enhanced
cystoscopy using blue-light-TURB
The primary endpoint of this randomized, single-center, non-inferiority trial is
short-term bladder cancer recurrence. Patients eligible for second-look
resection who are randomized to BL-TURB and demonstrate a very-low to low
likelihood of muscle-invasive disease on MRI will omit the second-look
resection, whereas patients randomized to WL-TURB will undergo the standard
second-look resection. Over 3 years, 327 patients with intermediate- or high
-risk NMIBCs* who are candidates for second-look TURBT will be enrolled. Results
will also include building a health economic lifetime model, looking at cost
-utility per quality-adjusted life year gained using 2-year clinical outcomes.
The CUT-less trial aims to generate evidence supporting a paradigm shift towards
a more personalized, socially, and economically sustainable updated NMIBC
therapeutic pathway across the European Union and potentially worldwide.
ClinicalTrial.gov identifier (ID): NCT05962541 Read more:
https://urosource.uroweb.org/resource-centres/EAU26/268344/abstract
A0649: Trial in progress: Evaluation of urinary minimal residual disease and
outcomes in high-risk non-muscle invasive bladder cancer surveilled with blue
light compared to white light cystoscopy
A.K. Smith, Bethesda (US)
Urinary comprehensive genomic profiling offers a non-invasive method to assess
the presence or extent of bladder cancer. The urinary biomarker UroAmp
(Convergent Genomics) detects minimal residual disease (MRD). By enhancing tumor
margin visualization, Blue Light Cystoscopy (BLC) may improve TURBT
(transurethral resection of bladder tumors) completeness. This randomized
controlled trial (RCT) enrolls high-risk NMIBC patients receiving either
standard of care white light or Blue Light Cystoscopy. UroAmp will be used to
evaluate completeness of resection for each modality.
The study will enroll 200 subjects undergoing TURBT for suspected high risk
NMIBC randomized 1:1 to WLC or BLC-enhanced cohorts. Urinary MRD analyses will
be conducted at all major decision points during treatment. The primary endpoint
is the post-TURBT difference in MRD scores between the BLC and WLC arms.
Secondary clinical outcomes include recurrence-free survival at 12 and 24
months.
Clinical Trial Registry number is NCT06525571. Read more:
https://urosource.uroweb.org/resource-centres/EAU26/268251/abstract
"Photocure's support for these trials underscores our commitment to the
transformation toward more personalized, data-driven care in uro-oncology,
enabling better clinical outcomes and supporting the shift toward precision
medicine. Minimally invasive procedures are on the rise and these trials address
data gaps in the care pathway and in the impact of complete TURBTs using BLC to
reduce tumor burden on clinical outcomes for high-risk patients. At Photocure,
we strongly believe that the clinical utility of different precision diagnostic
techniques can be optimized by using them in combination and in sequence
throughout the patient pathway to inform physician decision-making and provide
value for patients and healthcare. The same is true for their use in clinical
trials," said Anders Neijber, Chief Medical Officer of Photocure.
During the EAU Congress on March 13, 2026, Photocure, in collaboration with
medac, hosted a well-attended scientific event titled "Optimising Care in
Bladder Cancer." The session was moderated by Mr. John McGrath (Consultant
Urological Surgeon North Bristol Trust). The program brought together leading
clinicians to discuss current challenges and advances in bladder cancer
management, with a focus on improving patient pathways, in particular outcomes
for women. This collaboration between Photocure and medac reflects a shared
commitment to advancing evidence-based practice and supporting healthcare
professionals in delivering high-quality, patient-centered bladder cancer care.
*NMIBC: Non-muscle invasive bladder cancer
**TURBT: trans-urethral resection of bladder tumors
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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