Roche’s Tecentriq (compound: atezolizumab), the first immunotherapeutic bladder cancer treatment approved by the U.S. Federal Drug Administration, has failed Phase 3 clinical trials, the company said.

Since Roche won the accelerated approval by the results of Phase 2 trials of Tecentriq, the recent failure will make it difficult for the Swiss company to maintain FDA’s approval for Tecentriq, industry watchers say.

In a press release issued Wednesday, Roche said Phase 3 trials of Tecentriq, codenamed “IMvigor211,” had failed to meet primary assessment criteria of overall survival (OS), compared with chemotherapy.

The IMvigor211 aimed to confirm a previous trial called IMvigor210, which saw the tumor response rate and duration of response in patients whose disease had progressed during or following prior treatment with a platinum-based chemotherapy regimen, or who had disease progression within 12 months of treatment with a platinum-based neoadjuvant or adjuvant chemotherapy regimen.

As a result, Tecentriq’s stability conformed to what had been observed before but its overall survival rate fell short of reaching the targeted level, it said.

Roche plans to unveil the entire data of its Phase 3 trials toward the end of this year.

“While these results are not what we had expected, we believe that Tecentriq will continue to play a significant 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.”

News about Tecentriq’s failure came just hours after Merck and Pfizer confirmed the FDA granted accelerated approval for their immunotherapeutic bladder cancer treatments Bavencio, also called Avelumab.

Roche’s shares fell nearly 2 percent, but the Swiss pharmaceutical giant said it would not give up on Tecentriq.

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