The phase III IMvigor010 study assessing Tecentriq as an adjuvant (after surgery) monotherapy treatment has not achieved its primary endpoint of disease-free survival (DFS) compared against observation in people with MIUC.
Tecentriq is a monoclonal antibody engineered to combine with a PD-L1 protein, which is expressed on tumour cells and tumour-infiltrating immune cells. It helps to block its interactions with both PD-1 and B7.1 receptors. Tecentriq allows activating T cells by inhibiting PD-L1.
The IMvigor010 is a global phase III, open-label, randomised and controlled study designed to assess 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.
According to the company, safety for Tecentriq appeared consistent with the known safety profile of the medicine and no new safety signals have been detected.
Roche has a large development programme for Tecentriq, in addition to ongoing phase III studies in early and advanced bladder cancer.
The programme is comprised of multiple ongoing and planned phase III studies across different types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. It also included studies assessing Tecentriq both alone and in combination with other medicines.
Tecentriq secured approval in the US, EU and countries across the world, either alone or in combination with targeted therapies or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.
Roche global product development head and chief medical officer Dr Levi Garraway said: “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.
“We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers.”
In December 2019, Roche secured FDA approval for its Tecentriq plus chemotherapy for the initial treatment of metastatic non-squamous non-small cell lung cancer (NSCLC).