Roche’s Tecentriq fails trial

ZURICH: Roche’s Tecentriq drug has failed a late-stage trial in people with previously treated advanced bladder cancer, the Swiss drugmaker said yesterday, a setback in its plans to expand use of the immunotherapy.

The phase III IMvigor211 study that evaluated the drug, whose generic name is atezolizumab, in people with locally advanced or metastatic urothelial cancer whose disease progressed during or after treatment with chemotherapy “did not meet its primary endpoint of overall survival compared to chemotherapy”, it said.

The safety profile observed in the trial was consistent with what has been previously observed for the drug, it said. “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, the company’s chief medical officer.

“We are committed to helping people with advanced bladder cancer and will discuss these data with health authorities,” she said.

Its shares were initially 1.7% lower in pre-market activity.

The US Food and Drug Administration had granted accelerated approval for the drug based on previous trial data on bladder cancer patients whose disease progressed during or after chemotherapy. The follow-up IMvigor211 trial was designed to support full approval in the US and around the world.

Roche has more than 30 trials of the drug under way for potential use against lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder, and blood cancers.

Tecentriq, which is already on the market for treating bladder and lung cancer, generated sales of 113 million Swiss francs ($112 million) in the first quarter.