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Roche's Tecentriq Phase III IMvigor130 Study Meets Co-primary Endpoint

Swiss drug major Roche (RHHBY) announced Monday that the Phase III IMvigor130 study met its co-primary endpoint of investigator-assessed progression-free survival or PFS.

In the trial, 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 or mUC compared with chemotherapy alone.

The company noted that IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer.

Roche noted that encouraging overall survival results were observed at this interim analysis. However, these data are not yet mature and follow-up will continue until the next planned analysis, it said.

Roche will present the results at an upcoming medical meeting, and will share the data with health authorities globally, including the U.S. Food and Drug Administration and European Medicines Agency.

The company noted that Tecentriq was the first cancer immunotherapy approved in bladder cancer. There are four ongoing Phase III studies at present evaluating Tecentriq alone and in combination with other medicines in early and advanced bladder cancer.

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