There are around 200 000 cases of bladder cancer in the European Union every year. Of these, about 25% are diagnosed at a late stage wherein cancer has invaded the muscular wall (muscle-invasive bladder cancer, MIBC).The standard treatment for MIBC is radical cystectomy and eligible patients are offered neo-adjuvant chemotherapy (NAC). However, only 30% of these patients report a complete response. Even though the response to NAC is likely correlated to the underlying tumor biology (for example, the TP53-like MIBC subtype is associated with a higher frequency of resistance to NAC), there are today no approved biomarkers to select patients likely to benefit from NAC. This information could in turn translate into more precise and personalized treatment for the patient.
Elypta launched AURORAX-0093A to address the urgent unmet need to personalise therapy decisions in MIBC by developing new tests based on free GAGomes.
AURORAX-0093A (AUR93A) is a prospective observational in vitro diagnostics clinical development cohort study to develop free GAGome-based tests for the prognosis of muscle-invasive bladder cancer patients elected for neo-adjuvant chemotherapy before radical cystectomy.
AURORAX-0093A is registered at ClinicalTrials.gov (NCT05028660).