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Johnson & Johnson discontinues Phase III study of treatment for bladder cancer

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.

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.

Despite 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.

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