Roche provides an update on Phase III study of Tecentriq in people with muscle-invasive urothelial cancer
Basel, 24 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMvigor010 study evaluating Tecentriq (atezolizumab) as an adjuvant (after surgery) monotherapy
treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC). Safety for Tecentriq appeared consistent
with the known safety profile of the medicine, and no new safety signals were identified.
“Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers.”
In addition to ongoing Phase III studies in early and advanced bladder cancer, Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
About the IMvigor010 study
IMvigor010 is a global Phase III, open-label, randomised, controlled study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq compared to observation in 809 people with MIUC, who are at high risk for recurrence following resection. The primary endpoint is DFS as assessed by investigator, which is defined as the time from randomisation to invasive urothelial cancer recurrence or death.
About bladder cancer and muscle-invasive urothelial cancer
In 2018, there were over half a million new cases of bladder cancer diagnosed globally, with approximately 200,000 deaths from the disease.2 Urothelial cancer is the most common type of bladder cancer, accounting for about 90–95% of all cases.3 MIUC is a type of urothelial cancer that has spread into the muscle of the bladder, ureter or renal pelvis.4 Approximately 25% of new cases of bladder cancer are diagnosed with muscle-invasive disease,5 which is associated with a poorer prognosis than non-MIUC.4