Roche Announces Failure of Tecentriq Monotherapy in Phase III Adjuvant Trial for Muscle-Invasive Urothelial Cancer

January 26, 2020 /BioValleyBIOON/ -- Roche recently announced the results of the Phase III IMvigor010 study evaluating Tecentriq (atezolizumab) as adjuvant (postoperative) monotherapy for muscle-invasive urothelial carcinoma (MIUC).

This global, open-label, randomized, controlled Phase III study evaluated the efficacy and safety of adjuvant monotherapy with Tecentriq versus observation in 809 patients with muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence following radical cystectomy. The primary endpoint was investigator-assessed disease-free survival (DFS), defined as the time from randomization to recurrence of invasive urothelial carcinoma or death.

The results showed that, compared with observation, adjuvant monotherapy with Tecentriq did not meet the primary endpoint of improving DFS. In this study, the safety profile of Tecentriq was consistent with its known safety profile, and no new safety signals were identified.

Dr. Levi Garraway, Chief Medical Officer and Global Head of Product Development at Roche, stated, “It is very challenging to reduce the risk of recurrence after surgery for muscle-invasive urothelial carcinoma, and we are disappointed that disease-free survival was not significantly prolonged. We remain committed to exploring the potential benefits of immunotherapy for a broader population of patients with early-stage cancer.”

In addition to the ongoing Phase III studies in early- and late-stage bladder cancer, Roche has also developed an extensiveClinical TrialsDevelopment plan, including ongoing and planned Phase III studies involving multiple typesTumor, including lung cancer, genitourinary cancers, and skin cancer,Breast Cancer, gastrointestinal cancers, gynecologic cancers, and head and neck cancers. These studies are evaluating Tecentriq as monotherapy and in combination with other drugs.

In 2018, more than 500,000 new cases of bladder cancer were diagnosed globally, with approximately 200,000 deaths attributed to the disease. Urothelial carcinoma (UC) is the most common type of bladder cancer, accounting for approximately 90–95% of all cases. Muscle-invasive urothelial carcinoma (MIUC) is a form of UC that has spread into the muscle layers of the bladder, ureter, or renal pelvis. Approximately 25% of new bladder cancer cases areDiagnosisIt is a muscle-invasive disease, which has a worse prognosis compared to non-muscle-invasive urothelial carcinoma (non-MIUC).

The goal of early treatment for MIUC is to reduce the risk of disease recurrence or spread to other parts of the body. Since approximately half of MIUC patients will experience disease recurrence within two years after surgery, more postoperative treatment options are needed.

Tecentriq is a cancer immunotherapy whose active pharmaceutical ingredient is atezolizumab, a monoclonal antibody targeting the PD-L1 protein. It is designed to bind to PD-L1 on the surface of tumor cells and tumor-infiltrating immune cells, thereby blocking its interaction with the PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq enables the reactivation of T cells. The drug has the potential to serve as a foundational agent, used in combination with other immunotherapies, targeted therapies, and various chemotherapy regimens for the treatment of multiple types of cancer.Tumor。

Tecentriq has been approved in the United States, the European Union, and many other countries worldwide as a monotherapy or in combination with targeted therapies and/or chemotherapy for various types of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), certain types of metastatic urothelial carcinoma (mUC), and PD-L1-positive metastatic triple-negative breast cancer (TNBC). (Bioon.com)

Original Source:Roche provides an update on Phase III study of Tecentriq in people with muscle-invasive urothelial cancer