Roche’s Tecentriq fails trial in advanced bladder cancer

“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 wasn’t supposed to fail its phase 3 trial in second-line bladder cancer.

Tecentriq has plenty of rivals in bladder cancer ready to exploit this slip-up: AstraZeneca’s Imfinzi (durvalumab), and only yesterday, Pfizer/Merck KGaA’s Bavencio (avelumab) are approved in this indication, though now have similar conditional approvals.

Genentech said it will present full data from IMvigor211 at an undisclosed conference later this year. Safety also was deemed consistent with previously observed findings about the drug.

IMvigor211 was meant to validate the initial approval of Tecentriq in second-line bladder cancer, while another Phase 3 trial, IMvigor130, is ongoing and meant to validate the approval in first-line bladder cancer. Roche could not confirm the benefit of Tecentriq in these patients, therefore, FDA should yank the accelerated approval, if the agency follows it own rules.

Tecentriq’s failure in bladder cancer puts Leerink analyst Seamus Fernandez’s model at risk.

US health regulators on Tuesday granted accelerated approval for Pfizer Inc’s immuno-oncology drug Bavencio to treat advanced bladder cancer, marking the second approval in less than two months for the treatment developed along with Germany’s Merck KGaA.

The FDA previously granted accelerated approval to atezolizumab (Tecentriq, Genentech) – a monoclonal antibody created to bind with PD-L1 – for initial treatment of patients with locally advanced or metastatic urothelial carcinoma.

In October past year, tecentriq was approved as second-line treatment for NSCLC, after the drug had triumphed in Phase III trials.

Shares in Roche ticked down following the announcement, reflecting the importance of Tecentriq to the company.

Genentech noted that it has an extensive clinical trial development program 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.

Jefferies Equity Research has suggested peak sales as high as $12.7 billion for Tecentriq – but failure to maintain a licence in this key early indication would undermine confidence in the drug and place the sales in jeopardy, as the cancer immunotherapy market is becoming increasingly competitive.

Last year, Bristol Myers-Squibb’s Opdivo failed to do better than older chemotherapies. Some analysts have speculated that the latest trial results could threaten the future of the drug in bladder cancer and other types of cancer.

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