FDA says Tecentriq won't lose its bladder cancer nod despite phase 3 failure, Roche reports

Roche’s immuno-oncology drug Tecentriq took a surprising punch earlier this year when it failed a bladder cancer trial, putting a conditional approval in jeopardy. But the threat of losing FDA approval in bladder cancer has now passed.

After recent discussions with the agency, the company expects Tecentriq’s accelerated approval “will be maintained,” a spokeswoman with Genentech, the company’s U.S. unit, said Monday.

That applies to Tecentriq’s green light in previously untreated patients ineligible for cisplatin chemo and in patients who’ve had previous platinum therapy, she said. Both approvals cover patients with metastatic disease.

Hanging onto the bladder cancer indications is important for Tecentriq, which is competing against PD-1/L1 market leaders Opdivo and Merck, as well as two newer entrants into the class, Pfizer and Merck KGaA’s Bavencio and AstraZeneca’s Imfinzi. And it wasn’t guaranteed that the FDA would allow Tecentriq to continue drawing bladder cancer patients.

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The med was first approved in the field based on phase 2 data showing durable response, but the trial unveiled in May failed to prove it could actually prolong patients' lives. The bladder cancer indication, Tecentriq’s first, accounted for about 70% of the med’s sales at the time, analysts said.

“[W]e assume that this will put this indication at risk of being removed from the label,” Leerink analyst Seamus Fernandez wrote then, noting that the results were unexpected. “This comes as a surprise to us, considering Merck’s Keytruda showed an overall survival benefit.”

Roche will still have to generate confirmatory data in the second-line setting, however, a standard feature of accelerated approvals. “The FDA indicated that additional evidence is needed for confirmation of clinical benefit to support regular approval” for the indication in previously treated patients,” the spokeswoman said, “and that substantial evidence may be obtained from other ongoing trials.”

RELATED: Merck's Keytruda nabs I-O's third bladder cancer approval this month

Tecentriq’s failure in the IMVigor-211 study raised questions about other PD-1/L1 drugs approved to treat bladder cancer—which now amounts to all five in the field. Analysts suggested that the Tecentriq shortfall might mean all of those targeted drugs could end up producing similar results in that cancer type, despite a series of wins in a range of other cancers.

It could also mean, some posited, that it would be the PD-L1 side of the field was the group in most danger. So far, Keytruda is the only PD-1/L1 to post an overall survival advantage, and it’s a PD-1. In its own phase 2, Bristol-Myers’ Opdivo posted a higher response rate than Tecentriq did—and it’s also a PD-1.

But so far, there’s no more indication of a split there, and Merck rolled out more phase 3 data on Keytruda’s bladder cancer benefits at the European Society for Medical Oncology meeting over the weekend. In patients whose disease had progressed following platinum chemo treatment, Keytruda continued to demonstrate an overall survival advantage over chemo at a median follow-up of 22.5 months.

The med also reduced the risk of death by 30%, posting an overall survival advantage of 10.3 months versus chemo's 7.4 months. The 18-month overall survival rate was 33.2% for the Keytruda arm, compared with 19.7% for the chemo arm, Merck said.