US-based pharmaceutical company Johnson & Johnson has discontinued its SunRISe-2 study for TAR-200 in muscle-invasive bladder cancer (MIBC) patients not undergoing radical cystectomy.
The decision was made following a recommendation from an independent data monitoring committee based on a pre-specified interim analysis.
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The Phase III multi-centre, randomised trial aimed to assess the efficacy of TAR-200 in combination with cetrelimab against concurrent chemoradiotherapy.
It had enrolled MIBC patients who were not receiving radical cystectomy.
The study’s objective was to compare bladder intact-event free survival (BI-EFS) in participants receiving the combined treatment versus those undergoing standard chemoradiotherapy.
The interim analysis showed that treatment with TAR-200 did not demonstrate superiority to chemoradiation.
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By GlobalDataDespite this outcome of the SunRISe-2 trial, Johnson & Johnson has seen potential in TAR-200 in the SunRISe-4 study for MIBC.
In a statement, the company said: “Following an Independent Data Monitoring Committee recommendation and pre-specified interim analysis, SunRISe-2 was discontinued for not showing superiority versus chemoradiation.
“Based on data presented, we are highly confident in TAR-200 as a transformative therapy for bladder cancer where innovative and bladder-sparing options are urgently needed.“
Johnson & Johnson said it is on track for a US Food and Drug Administration (FDA) filing of TAR-200 monotherapy based on data from the SunRISe-1 trial in non-muscle invasive bladder cancer, with a target date set for early next year.
The company has also confirmed that the SunRISe-3 and SunRISe-5 studies of TAR-200 are still in progress in participants with BCG-naïve high-risk non-muscle invasive bladder cancer (HR-NMIBC) and HR-NMIBC following Bacillus Calmette-Guérin (BCG), respectively.
Last month, Johnson & Johnson reported data from the Phase III CARTITUDE-4 clinical trial in which CARVYKTI (ciltacabtagene autoleucel), its cell therapy, showed the potential to improve overall survival in patients with multiple myeloma.
The trial enrolled patients who had received at least one prior line of therapy, including a proteasome inhibitor.
