Muscle-invasive urothelial cancer: Atezolizumab as adjuvant monotherapy treatment did not meet its primary endpoint in IMvigor010
The phase III IMvigor010 study evaluating Atezolizumab ( Tecentriq ) 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 Atezolizumab appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.
The goal in treating MIUC early is to reduce the risk of the disease recurring or spreading to other parts of the body.
More treatment options following surgery are needed as approximately half of people with MIUC will develop a recurrence of their disease within 2 years of surgery.
IMvigor010 was a global phase III, open-label, randomised, controlled study designed to evaluate the efficacy and safety of adjuvant treatment with Atezolizumab 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.
In 2018, there were over half a million new cases of bladder cancer diagnosed globally, with approximately 200,000 deaths from the disease.
Urothelial cancer is the most common type of bladder cancer, accounting for about 90–95% of all cases.
MIUC is a type of urothelial cancer that has spread into the muscle of the bladder, ureter or renal pelvis.
Approximately 25% of new cases of bladder cancer are diagnosed with muscle-invasive disease, which is associated with a poorer prognosis than non-MIUC.
Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Atezolizumab may enable the activation of T cells. ( Xagena )
Source: Roche, 2020