Roche hits pause on Tecentriq-Cotellic trial enrollment after deaths raise red flags

Roche is looking to move Tecentriq into metastatic colorectal cancer. The therapy currently bears FDA green lights in lung cancer and bladder cancer. (Image: Roche)

Roche may have just hit a snag in its bid to push a combo of Tecentriq and Cotellic into metastatic colorectal cancer (mCRC).

Wednesday, the company said it had temporarily pressed pause on enrollment for a phase 2 study examining the pair as a maintenance therapy for first-line mCRC. The reason? An imbalance in the number of deaths in the trial’s experimental arm, a spokeswoman for Roche’s Genentech said.

The decision follows a review from an independent data monitoring committee (IDMC) that tallied three deaths in the Tecentriq-Cotellic group—one, from cardiogenic shock, that was treatment-related, and two that came as a result of disease progression. Since then, the company has learned of another death, though that latest report was “documented as not related to study treatment,” the spokeswoman said.

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While researchers haven’t identified any new safety signals for the Tecentriq-Cotellic duo, “patient safety is our highest priority,” and “we are taking this proactive step to ensure the combination is appropriately evaluated in the maintenance setting,” the spokeswoman said, adding that “in close communication with the IDMC, we will determine the right path forward” for the trial.

Patients already enrolled in the study and receiving the regimen can continue to do so, the spokeswoman said.

With investors these days closely watching immuno-oncology studies for clues as to how the lucrative market will shape up, Roche was quick to point out that the move “has no impact on other trials involving Tecentriq and Cotellic,” including IMblaze370, a phase 3 study investigating the cocktail as a third-line mCRC treatment, whose first results are due out soon.

“We look forward to providing top-line results for this study in the first half of 2018,” the spokeswoman said.

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If Tecentriq and Cotellic can win an approval in mCRC, it’ll mean new markets for both drugs. Cotellic is currently approved alongside fellow Roche med Zelboraf for melanoma treatment, while immuno-oncology treatment Tecentriq boasts FDA green lights in both lung cancer and bladder cancer.

Those are two areas that have quickly grown crowded with PD-1 and PD-L1 options, though—and first-line lung cancer in particular is an area where Tecentriq is still unproven, meaning it’s critical for Roche to rack up additional indications. It’s counting on Tecentriq, as well as other new meds such as multiple sclerosis therapy Ocrevus, to kick in big sales as biosimilars makers target its older cancer products.