New immune biomarker panel may predict bladder cancer treatment response: Monash researchers
A Monash University team has developed a new immune-based biomarker panel that may help predict which bladder cancer patients are unlikely to respond to standard immunotherapy—enabling more personalised treatment from the outset.
The study, led by urologist and clinician-researcher Dr Weranja Ranasinghe from the School of Clinical Sciences at Monash Health, addresses a critical gap in the treatment of non-muscle invasive bladder cancer (NMIBC)—a common form of bladder cancer where recurrence or progression can occur in up to 45% of patients despite standard care.
BCG (Bacillus Calmette–Guérin) immunotherapy is the gold-standard treatment for high-risk NMIBC and is administered directly into the bladder to stimulate an immune response against cancer cells. While effective for many, a significant proportion of patients do not respond—and until now, clinicians have had no way to predict who will benefit from treatment.
“Our research has identified some markers that could help identify a group of patients who are unlikely to respond to traditional BCG treatment for bladder cancer where other options can be offered,” said Dr Ranasinghe.
A five-marker panel with clinical potential
Through funding from the ANZUP Below the Belt Research Fund, Dr Ranasinghe and his team analysed tumour samples from patients who did and did not respond to BCG therapy. They identified a set of immune features—including CD4:CD8 T cell ratios, Th2:Th1 immune dominance, and PD-1 expression patterns—that were significantly associated with BCG failure.
These features were combined into a novel biomarker panel known as BCG-R5, which achieved strong predictive potential.
Importantly, the BCG-R5 panel can be assessed using standard immunohistochemistry (IHC)—a widely available and cost-effective method already used in most pathology laboratories.
“Unlike genomic sequencing, this test can be implemented using existing clinical tools, making it practical and scalable,” said Dr Ranasinghe. “It could be used before treatment to guide decision-making and reduce delays in offering effective alternatives.”
A path toward more personalised care
The team’s findings suggest that some bladder cancers are inherently immune cold or immune exhausted—meaning they are less likely to respond to BCG, which relies on immune activation. These tumours may require alternative treatment strategies.
The BCG-R5 panel is now undergoing prospective validation, including planned trials comparing BCG to emerging therapies such as gemcitabine-docetaxel (Gem-Doce).
“This work supports a broader shift toward personalised bladder cancer care,” said Dr Ranasinghe. “We are learning how to match the right treatment to the right patient earlier in their care journey—potentially improving outcomes and reducing unnecessary treatment exposure.”
About the researchers
Dr Ranasinghe leads a multidisciplinary team based at Monash University’s School of Clinical Sciences at Monash Health, in collaboration with clinicians from Monash Health, bringing together expertise in urological oncology, immunopathology, and translational biomarker research to improve treatment pathways for bladder cancer. The group is committed to improving risk stratification and therapy sequencing for patients with urological cancers.
The study was supported by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group through its Below the Belt Research Fund.
About Monash University
Monash University is Australia’s largest university with more than 80,000 students. In the 60 years since its foundation, it has developed a reputation for world-leading high-impact research, quality teaching, and inspiring innovation.
With four campuses in Australia and a presence in Malaysia, China, India, Indonesia and Italy, it is one of the most internationalised Australian universities.
As a leading international medical research university with the largest medical faculty in Australia and integration with leading Australian teaching hospitals, we consistently rank in the top 50 universities worldwide for clinical, pre-clinical and health sciences.
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