Phase III IMvigor130 study of Tecentriq reduces the risk of disease worsening or death in previously untreated locally advanced or metastatic urothelial carcinoma

Genentech, a member of the Roche Group announced that the Phase III IMvigor130 study met its co-primary endpoint of investigator-assessed progression-free survival (PFS) . The combination of Tecentriq (atezolizumab) plus platinum-based chemotherapy showed a statistically significant reduction in the risk of disease worsening or death in people with previously untreated locally advanced or metastatic urothelial carcinoma (mUC) compared with chemotherapy alone. Encouraging overall survival (OS) results were observed at this interim analysis, however these data are not yet mature and follow-up will continue until the next planned analysis. Safety in the Tecentriq plus chemotherapy arm appeared consistent with the known safety profiles of the individual medicines and no new safety signals were identified with the combination. Results will be presented at an upcoming medical meeting and shared with health authorities globally, including the (FDA).

Tecentriq was the first cancer immunotherapy approved in bladder cancer. Tecentriq has accelerated approval from the FDA for the treatment of adults with locally advanced or mUC, including those who are not eligible for cisplatin-containing chemotherapy and whose tumors express high levels of PD-L1 (PD-L1–stained tumor-infiltrating immune cells covering greater than 5 percent of the tumor area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The accelerated approval also includes the treatment of adults with locally advanced or mUC whose disease had progressed during or following platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). These accelerated approvals are based on tumor response rate and durability of response. Continued approval in these types of bladder cancer may be contingent upon verification and description of clinical benefit in a confirmatory trial.