Tecentriq (atezolizumab) fails Phase III trial for locally advanced or metastatic urothelial cancer after treatment with a platinum-based chemotherapy .- Genentech + Roche

Genentech, announced that the Phase III IMvigor211 study that evaluated Tecentriq (atezolizumab) in people with locally advanced or metastatic urothelial cancer (mUC) whose disease progressed during or after treatment with a platinum-based chemotherapy (previously treated) did not meet its primary endpoint of overall survival (OS) compared to chemotherapy. The safety profile observed in IMvigor211 was consistent with what has been previously observed for Tecentriq.

The results observed in people treated with Tecentriq in IMvigor211 were generally consistent with those observed in a similar group of people in the Phase II IMvigor210 study. The IMvigor211 data will be further examined in an effort to better understand these results, including the initial observation that the chemotherapy arm results were better than study design assumptions. Full data from IMvigor211 will be presented later this year.

The FDA recently granted accelerated approval to Tecentriq as an initial treatment for people with locally advanced or mUC who are not eligible for cisplatin chemotherapy. A Phase III confirmatory study, IMvigor130, is currently ongoing in this population. Genentech has an extensive clinical trial development program for Tecentriq, with more than 30 trials ongoing, 17 of which are ongoing or planned Phase III studies across several kinds of lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder and blood cancers. This includes trials evaluating Tecentriq both alone and in combination with other medicines.

Comment: Genentech/Roche intended that the data from IMvigor211 would support full approval globally and to serve as the confirmatory study to convert the accelerated approval to full approval in the US.