J&J speeds into new bladder cancer trial
The company takes another project from Taris into phase 3 as it chases a $5bn market.
The company takes another project from Taris into phase 3 as it chases a $5bn market.
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
Project | Description | Status | Data so far |
---|---|---|---|
TAR-210 | Erdafitinib intravesical drug delivery system | Ph3 Moonrise-1 vs chemo in intermediate-risk pts with FGFR alterations | Ph1 data at ESMO 2023: 87% CR rate in 15 pts in cohort 3 (BCG-naive) |
Balversa | Erdafitinib, oral FGFR kinase inhibitor | Ph2 Thor-2 vs chemo in high-risk BCG-experienced pts with FGFR mutations | Data at ESMO 2023: 72% reduction in risk of recurrence/death in 73 pts in cohort 1 (post-BCG) |
TAR-200 | Gemcitabine intravesical drug delivery system | Ph3 Sunrise-3 +/- cetrelimab vs BCG in BCG-naive high-risk pts; ph3 Sunrise-5 vs investigator’s choice chemo in high-risk BCG-experienced pts | Ph2 Sunrise-1 in high-risk BCG-unresponsive pts, data at ESMO 2023: 77% CR rate in 30 pts |
Source: OncologyPipeline & clinicaltrials.gov.
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