Chugai Seeks Japanese Approval For Tecentriq, Phase III IMvigor011 Data Supports Filing In MRD-Positive Muscle-Invasive Bladder Cancer

Chugai Pharmaceutical announced that it has submitted a regulatory application in Japan to expand the use of Tecentriq (atezolizumab) as adjuvant therapy for patients with muscle-invasive bladder cancer who are minimal residual disease (MRD) positive. The filing was made with the Ministry of Health, Labour and Welfare and seeks approval for an additional indication of the intravenous anti-PD-L1 antibody in this post-surgery setting.

The application is supported by data from the global Phase III IMvigor011 study, which compared Tecentriq monotherapy with placebo in patients whose circulating tumour DNA indicated MRD-positive disease. The trial met both its primary endpoint, disease-free survival, and its key secondary endpoint, overall survival, demonstrating statistically significant and clinically meaningful benefits for patients receiving Tecentriq.

“Muscle-invasive bladder cancer has a high recurrence rate after surgery, underscoring the need to optimise adjuvant treatment based on each patient’s individual risk. Tecentriq offers a new adjuvant treatment option for patients identified as having a high risk of recurrence through the detection of circulating tumour DNA (ctDNA) in blood tests. By advancing the personalisation of cancer care, we remain committed to securing approval so that every patient can receive the most appropriate treatment for their condition,” said Chugai's President and CEO, Dr Osamu Okuda.

The study's safety findings were consistent with Tecentriq’s well-characterised profile from earlier clinical programs. IMvigor011 was designed to assess not only efficacy but also long-term tolerability in this high-risk bladder cancer population.

Chugai reaffirmed its commitment to developing innovative oncology medicines that address unmet needs, emphasising its focus on supporting both patients and healthcare professionals through new treatment options.