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news.Roche’s phase III IMvigor211 study of 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) has failed to meet its primary endpoint of overall survival (OS) compared to chemotherapy.
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The safety profile observed in IMvigor211 was consistent with what has been previously observed for Tecentriq.
“While these results are not what we had expected, we believe that Tecentriq will continue to play an important role in the treatment of people with advanced bladder cancer,” said Sandra Horning, M.D., chief medical officer and Head of Global Product Development. “We are committed to helping people with advanced bladder cancer and will discuss these data with health authorities.”
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.
Tecentriq was granted accelerated approval by the U.S. Food and Drug Administration (FDA) based on tumour response rate and duration of response in IMvigor210 for the treatment of people with locally advanced or mUC who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).
IMvigor211 was a randomised pivotal study designed to support full approval globally and to serve as the confirmatory study to convert the accelerated approval to full approval in the US.
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 pivotal study, IMvigor130 is currently ongoing in this population.
Roche has an extensive clinical trial development programme 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.
