Pharmaceutical major Johnson & Johnson (J&J) has halted the late-stage SunRISe-2 study of its bladder cancer drug candidate TAR-200, owing to unfavourable results.
TAR-200 did not outperform chemoradiation in treating muscle-invasive bladder cancer (MIBC) in the Phase 3 study.
The asset was being evaluated alongside an investigational antibody in MIBC patients who had not undergone radical cystectomy to eliminate the bladder and nearby tissues. This combination was compared to concurrent chemoradiotherapy.
SunRISe-2 aimed to measure the time from the onset of treatment until the patient continues to be free of certain complications, such as cancer recurrence or death, reported Reuters.
Johnson & Johnson’s decision to discontinue the trial came after an independent data monitoring committee recommended stopping it based on interim analysis.
TAR-200 is designed to be a targeted drug release system to deliver chemotherapy directly into the bladder over an extended period, according to the pharma major.
Johnson & Johnson said that TAR-200 will remain a potential therapy for bladder cancer, especially in areas where bladder-sparing options are urgently needed.
The company has presented promising results from the SunRISe-4 study, highlighting TAR-200’s potential in treating MIBC.
Furthermore, the pharma giant is on track to seek the US Food and Drug Administration (FDA) approval for TAR-200 monotherapy in non-muscle invasive bladder cancer by early 2025.
The positive data from Phase 2b SunRISe-1 was announced last month. The candidate demonstrated a high complete response rate without the need for reinduction or additive therapy.
The investigation drug is also being assessed in SunRISe-3 and SunRISe-5 trials.
Johnson & Johnson is also conducting a mid-stage study of TAR-200 in patients with MIBC, who are scheduled for bladder removal but are ineligible for or refuse chemotherapy.
Recently, the pharmaceutical firm discontinued a mid-stage field study of its investigational pill for dengue prevention.
