Drama as Roche's Tecentriq fails in key bladder cancer trial

Drama as Roche's Tecentriq fails in key bladder cancer trial

"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 at Roche.

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.

The company said 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.

Based on the MIvigor210 data, FDA granted Tecentriq accelerated approval previous year 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). The company plans to present full data from the trial later this year. The FDA previously granted accelerated approval to atezolizumab for this patient population.

Tecentriq was predicted by some analysts to capture the highest proportion - up to 40 percent - of estimated peak market sales of about $2.3 billion among PD-1/PD-L1 inhibitors targeting bladder cancer.

It's worth noting that all the checkpoint inhibitors have been approved or sought conditional approval on the basis of phase II data showing tumour responses rather than survival data, although Merck has since published results for Keytruda showing a survival advantage.

The IMvigor211 trial was the first randomized late-stage study of atezolizumab compared with chemotherapy in patients with advanced bladder cancer who were previously treated with platinum-based chemotherapy.

"We have several other ongoing studies of Tecentriq in different types of bladder cancer, including the phase III IMvigor010 study of Tecentriq as an adjuvant therapy in people with muscle-invasive bladder cancer and a phase Ib study of Tecentriq in non-muscle invasive bladder cancer", Genentech spokeswoman Austine Graff told BioWorld Today.

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.

The tactic was a success allowing the drug to rack up sales of around $270m in its first 12 months on the market, split roughly two thirds to one third between bladder and lung cancer, its second major indication.

Last year, Bristol Myers-Squibb's Opdivo failed to do better than older chemotherapies.

The failure of Tecentriq is the latest instance where cancer immunotherapies have not lived up to their promise of revolutionising treatment.