05 April 2018 - Products
Wednesday April 5thRoche announced that they are temporarily pausing on enrollment for a phase-2 study regarding the combination of Tecentriq (atezolizumab) and Cotellic (cobimetinib) as a maintenance therapy for first-line mCRC.
A spokeswoman for Roche’s Genentech stated that the reason is apparently an imbalance in the number of deaths in the trial’s experimental arm.
The decision follows a review from an independent data monitoring committee (IDMC) that registered three deaths in the Tecentriq-Cotellic group, one from treatment-related cardiogenic shock, two as a result of disease progression.
"Patient safety is our highest priority,” and "we are taking this proactive step to ensure the combination is appropriately evaluated in the maintenance setting,” Roche’s spokeswoman stated, adding that "in close communication with the IDMC, we will determine the right path forward” for the trial. However, she added, "patients already enrolled in the study and receiving the regimen can continue to do so”.
Roche promptly pointed out that the move "has no impact on other trials involving Tecentriq and Cotellic,” including IMblaze370, a phase 3 study investigating the combination of substances as a third-line mCRC treatment, whose first results are expected in the first half of 2018.
The approval of a combination of Tecentriq and Cotellic for the treatment of mCRC could open a new market for the two drugs. Cotellic is currently approved alongside Roche’s Zelboraf (vemurafenib) for melanoma treatment, while Tecentriq has been approved by FDA as a therapy for both lung cancer and bladder cancer.
First-line lung cancer in particular is an area where the efficacy of Tecentriq is still unproven, meaning it’s critical for Roche to prove its benefits for additional indications.
Tecentriq and multiple sclerosis therapy Ocrevus (ocrelizumab) are considered by Roche their ace products for 2018 as several biosimilar makers target its older cancer products.
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