The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said IV Tecentriq atezolizumab (MPDL3280A, RG7446) missed the primary endpoint of improving overall survival (OS) vs. chemotherapy in the confirmatory Phase III IMvigor211 trial in 931 patients with locally advanced or metastatic urothelial cancer who progressed during or after treatment with a platinum-based chemotherapy. The humanized mAb against PD-L1 has accelerated approval in the U.S. as second-line treatment for bladder cancer and Genentech had intended IMvigor211 to support full approval of the drug in the indication worldwide.
The open-label, international trial had a hierarchical design which required the primary endpoint be met in a first cohort of patients with the highest levels of PD-L1 expression before moving on to a second cohort of patients with any level of PD-L1 expression and then the overall study population. Genentech declined to say in which cohort Tecentriq failed. Full data from IMvigor211 will be presented this year. Secondary endpoints in the trial include objective response rate (ORR), progression-free survival (PFS), duration of response, safety, immunogenicity, pharmacokinetics and quality of life (QOL)...
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