Roche yanks Tecentriq kidney cancer apps in U.S., EU

Roche’s immuno-oncology rivals are hurtling toward a showdown in previously untreated kidney cancer. But the Swiss drugmaker has decided to pull its horse out of the race.

Roche has withdrawn applications to both the FDA and the European Medicines Agency (EMA) for a combination of Tecentriq and Avastin in first-line patients, a spokeswoman confirmed via email. The company cited "results that are not sufficient to support an extension of indication" in its letter (PDF) to European regulators.

The Basel-based company filed the applications earlier this year on the back of data from its phase 3 IMmotion151 study, which showed the Tecentriq-Avastin regimen could top Pfizer’s Sutent at cutting the risk of disease worsening or death in patients whose tumors expressed biomarker PD-L1.

Since then, though, plenty has changed in the kidney cancer landscape, setting Roche’s rivals up to make a splash. Last month, partners Pfizer and Merck KGaA unveiled data showing that a pairing of their PD-1/PD-L1 entrant, Bavencio, and Sutent follow-up Inlyta could stave off cancer progression by a median 13.8 months, compared with 8.4 months for Sutent. In PD-L1-positive patients, the 13.8-month benefit nearly doubled Sutent’s at 7.2 months.

And just a few days prior, Merck took things a couple steps further with the top-line announcementthat a combination of its Keytruda and Inlyta had not only shown it could keep cancer at bay for longer than Sutent, but that it could beat out the standard-of-care at extending patients’ lives, too. And those benefits were consistent across PD-L1 expression levels, the New Jersey drugmaker said.

With the Tecentriq-Avastin cocktail, Roche would have had to go up against both those regimens sooner or later—and that’s not to mention Bristol-Myers Squibb’s Opdivo-Yervoy duo, which has been snatching up front-line market share in the U.S. since its April green light. And while Bristol’s one-two punch has been stymied in Europe thanks to the EMA’s Committee for Medicinal Products for Human Use—it shot down the combo in July—that may be about to change. Last week, the committee did an about face, recommending the cocktail for first-line use.

Roche isn’t throwing in the towel completely, though. The IMmotion151 study will continue as planned until the pharma giant knows whether its combo can extend patients’ lives, and "we will continue to evaluate the results from the study," the spokeswoman said.

"Based on data we have available, we believe that the combination of Tecentriq and Avastin may play a role in the treatment of advanced kidney cancer, which remains an area of high unmet medical need where people need more treatment options," she added.

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