J&J speeds into new bladder cancer trial

Johnson & Johnson’s 2019 purchase of Taris Biomedical might not have broken the bank, but the group has high hopes for its target’s drug-delivery technology, previously saying it could drive $5bn peak annual sales.

Last week the big pharma took a second Taris-based asset, the erdafitinib-releasing TAR-210, into phase 3. J&J already markets erdafitinib in metastatic bladder cancer, where it is branded Balversa. With its new formulation the group hopes to go earlier in the disease and address a greater proportion of patients.

The Taris system is placed within the bladder, where it releases its payload. J&J estimated during its Decemer 2023 business review that this localised approach could address around 95% of bladder cancer patients, versus the 5% or so who have metastatic disease.

Non-muscle invasive

The setting for TAR-210’s phase 3 trial, Moonrise-1, is intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients with FGFR alterations. The project will be compared against investigator’s choice of intravesical chemotherapy.

J&J has moved quickly into pivotal studies, having so far reported data from just one phase 1 trial of TAR-210. However, its decision might not be as rash as it appears at first glance: the group already has data on Balversa in NMIBC, so will have a good idea of TAR-210's likely activity here.

The phase 1 study of TAR-210, presented at last year’s ESMO meeting, found an 87% complete response rate among a cohort of 15 patients with intermediate-risk NMIBC.

There was also an 82% recurrence-free rate in a different cohort of patients with high-risk NMIBC who had previously received Bacillus Calmette Guérin (BCG), which is a standard therapy option for high-risk and, sometimes, intermediate-risk NMIBC. 

So far, J&J has not disclosed any plans for phase 3 development of TAR-210 post-BCG.

However, the group’s most advance Taris-based project, TAR-200, is being tested in both BCG-naive and experienced high-risk NMIBC patients, as well as in muscle-invasive bladder cancer. This asset elutes the chemotherapy drug gemcitabine. 

J&J says it hopes eventually to replace BCG, which is inconvenient, comes with side effects and has a reccurrence rate of around 40%. The company has estimated that only 16% of patients tolerate a full course of BCG; further complicating the bladder cancer landscape, there have been recent BCG shortages.

It will be several years until it becomes apparent whether TAR-210 and TAR-200 provide an alternative – and, if so, whether they can hit the lofty sales goals that J&J has set.

J&J’s efforts in non-muscle invasive bladder cancer

Source: OncologyPipeline & clinicaltrials.gov.