Star Cancer Drug Tecentriq Flops in Late-Stage Trial

Star Cancer Drug Tecentriq Flops in Late-Stage Trial

Star Cancer Drug Tecentriq Flops in Late-Stage 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", Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release.

Roche has been poleaxed by the news that its immuno-oncology flagship drug Tecentriq failed a phase III trial in bladder cancer that was supposed to transform its earlier conditional nod into a full approval. Though it was first in the PD-1/PD-L1 class to win an FDA nod in bladder cancer, since then, Big Pharma rivals have piled in: Bristol-Myers Squibb's Opdivo, Merck & Co.'s Keytruda, AstraZeneca's newly minted Imflinzi (durvalumab), Pfizer and Merck KGaA's Bavencio (avelumab), which just nabbed its bladder cancer nod this week.

Genentech said it will present full data from IMvigor211 at an undisclosed conference later this year.

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. Fernandez predicted that Keytruda will gain full approval on or before its June 14 PDUFA date, based on data from the confirmatory phase III KEYNOTE-045 trial.

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.

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The FDA granted accelerated approval of TECENTRIQ for this group of mUC patients a year ago.

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.

Shares in Roche ticked down following the announcement, reflecting the importance of Tecentriq to the company. "This puts the existing US bladder cancer approval in serious doubt, and will also, of course, raise market concerns about Tecentriq's efficacy in other cancer types", Kepler Cheuvreux analyst David Evans wrote in a note to investors, according to a report in Reuters. In addition to bladder cancer, they include kidney, skin, breast, colorectal, prostate, ovarian, blood and several kinds of lung cancers, alone and in combination with other agents.

In the first quarter, sales of Tecentriq, also known as atezolizumab, hit 113 million Swiss francs ($112.45 million), more than the 103 million estimate in a Reuters poll.

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

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