Valar Labs Announces Validation of First Histology-based Test to Predict Response to BCG in Bladder Cancer
01 May 2024 - 2:57PM
Business Wire
–Vesta, an Innovative New Diagnostic
Test to Guide First-Line Treatment Decisions–
Valar Labs, the developer of computational histology AI tests
for predicting response to cancer therapies, announced new data
today which is being presented on Saturday, May 4, 2024 at the 2024
Annual Meeting of the American Urological Association (AUA) as a
podium presentation (PD30-03). The study demonstrated that the
first-ever computational histology AI (CHAI) assay with biomarkers
for response prediction in bladder cancer can help urologists make
more informed treatment decisions for their patients. The
biomarkers were successfully validated across 1000+ patients and 12
centers on four end-points, making it the largest validation study
of its kind in bladder cancer.
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The CHAI biomarkers offer independent
prognostic capabilities for high-grade recurrence and
muscle-invasive progression in bladder cancer. Additionally, they
identify patients less likely to benefit from BCG therapy.
Validated across more than 1,000 patients and 12 centers, these
biomarkers, available through the Vesta test, can enhance
first-line treatment decision-making for non-muscle invasive
bladder cancer. (Graphic: Business Wire)
“Our study demonstrates that the CHAI biomarkers can identify
patients with high-risk non-muscle invasive bladder cancer for whom
BCG therapy is likely to be ineffective, across a diverse set of
patients,” said Yair Lotan, M.D., Professor of Urology, Chief of
Urologic Oncology, and holder of the Jane and John Justin
Distinguished Chair in Urology, in Honor of Claus G. Roehrborn,
M.D. at UT Southwestern Medical Center. “It’s crucial to spare
non-responding patients from the unnecessary toxicity of
ineffective treatments and to allocate BCG more effectively,
especially amidst the current nationwide BCG shortage.”
Data showed that patients with biomarker present had 3x elevated
risk of progression to muscle invasive disease within 3 years.
Additionally, patients with biomarker present had 2x elevated risk
of non-response to Bacillus Calmette-Guerin (BCG) as well as
high-grade recurrence within 6 and 24 months. The biomarkers
demonstrated significant predictive ability across all subgroups
and provided independent prognostic capabilities beyond common
clinical risk factors.
“Accurately identifying patients with high-risk non-muscle
invasive bladder cancer that will not respond to BCG is essential
so they can receive the treatment that is best suited for them,”
said Stephen B. Williams, M.D., Associate Chief Medical Officer,
Chief of Urology, Director of Urologic Oncology at The University
of Texas Medical Branch. “There are multiple therapies that are
coming to market and some of which are already being used, such as
the combination of gemcitabine and docetaxel, that should be
considered for patients with CHAI biomarkers present.”
The CHAI biomarkers consists of 600 features measuring tumor and
tumor micro-environment characteristics that include features
indicative of tumor aggressiveness, nuclear and cellular
pleomorphism, mitotic activity, and immune infiltration.
“Bladder cancer presents a significant challenge, affecting over
80,000 individuals annually and until now, it has been markedly
underserved by advancements in precision medicine,” said Anirudh
Joshi, co-founder and CEO of Valar Labs. “With response rates to
BCG treatment as low as 50%, physicians have long sought tools like
our CHAI biomarkers to better manage patient care. We are deeply
committed to addressing this deficiency by advancing precision
diagnostics in bladder cancer.”
“We are incredibly excited to have completed the validation of
these biomarkers for predicting response to the standard of care
therapy in high-risk non muscle-invasive bladder cancer. We are
eager to make this transformative test available to every patient
and physician across the country,” said Damir Vrabac, co-founder
and COO of Valar Labs. “A test that identifies patients unlikely to
respond to BCG will empower physicians to tailor treatment pathways
more effectively and enhance patient outcomes.”
“Computational histology AI biomarkers are extremely powerful
and we are just scratching the surface of what this technology is
capable of,” said Viswesh Krishna, co-founder and CTO of Valar
Labs. “We are proud to be at the forefront of this groundbreaking
shift in diagnostics, uncovering new sets of biomarkers based on
histology. We are able to visualize these biomarkers and gain a
better understanding of how tumor morphology correlates to
treatment response.”
About Valar Labs:
Valar Labs is a precision medicine company developing
computational histology AI tests for predicting response to cancer
therapies. Our goal is to provide every patient and physician the
ability to select the best treatment based on the patient's tumor
biology. Our bladder cancer test, Vesta, predicts which patients
are unlikely to benefit from BCG therapy and provides detailed risk
stratification for recurrence and progression. Vesta is clinically
available through our CLIA-certified laboratory in Houston, Texas
and can be ordered online. For more information, please visit
www.valarlabs.com and follow us on LinkedIn and Twitter.
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