HQ Team
October 8, 2024: Johnson and Johnson discontinued a study of an investigational drug to treat bladder cancer after it failed to yield desired results.
The study, dubbed SunRise-2, did not show superiority compared to standard-of-care chemoradiation for muscle-invasive bladder cancer, according to a company statement.
The data for the experimental drug, TAR-200, went through a review by an Independent Data Monitoring Committee and a “pre-specified interim analysis.”
TAR-200 is a targeted drug release system designed to slowly release a chemotherapy drug into the bladder over an extended period.
The company tested the drug combination in a mid-stage study in patients who are scheduled for surgical removal of the bladder who are ineligible for, or refuse, chemotherapy.
‘Intact-event-free survival’
The main goal was to compare the period from the beginning of the drug combination treatment till the patient remains free of complications, including recurrence of cancer and death.
“The study aimed to compare bladder intact-event-free survival in participants receiving TAR-200 in combination with intravenous cetrelimab compared to concurrent chemoradiotherapy,” according to a posting on the government’s clinical trials website.
The data, recently presented at the Europen Society of Medical Oncology 2024 Congress, showed TAR-200 in combination with cetrelimab achieved nearly double the pathological complete response rate compared to centrelimab alone in patients.
This showed “the potential of TAR-200 in muscle-invasive bladder cancer and we will continue to pursue approaches to advance care in this setting,” according to the statement.
Non-muscle invasive bladder cancer
“We are highly confident in TAR-200 as a transformative therapy for bladder cancer where innovative and bladder-sparing options are urgently needed.”
Johnson and Johnson is on target for the US FDA filing of TAR-200 monotherapy in non-muscle invasive bladder cancer in early 2025. Two other mid-stage studies are underway.
Invasive cancer, where the disease has grown into the muscle tissue of the bladder, represents a quarter of all newly diagnosed bladder cancer cases, according to Johnson and Johnson.
