Roche’s immunotherapy Tecentriq has failed to significantly improve overall survival compared to chemotherapy in pre-treated patients with advanced bladder cancer, marking a major setback for the drug.

The Phase III IMvigor211 study assessed Tecentriq (atezolizumab) in people with locally advanced or metastatic urothelial cancer (mUC) whose disease progressed during or after treatment with a platinum-based chemotherapy, but did not meet its primary endpoint.

Roche noted that data from the trial will be “further examined in an effort to better understand these results”, including an initial observation that the chemotherapy arm results were better than study design assumptions, and that full results will be presented later this year.

Nevertheless, these findings are a blow to Roche. Tecentriq was granted accelerated approval in the US based on tumour response rate and duration of response seen in the IMvigor210 study to treat 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).

The firm was hoping 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.

“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, chief medical officer and head of Global Product Development at Roche. “We are committed to helping people with advanced bladder cancer and will discuss these data with health authorities.”

The FDA also recently granted accelerated approval to the drug 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 still ongoing in this population.

Tecentriq is currently available to UK patients with advanced bladder cancer who have already received chemotherapy through the country’s Early Access to Medicines Scheme, while regulators in Europe continue to review its marketing application.