Following a number of reported deaths, Roche has halted a clinical trial involving a combination of the cancer drugs Tecentriq and Cotellic, which were being tested to see if they were safe and effective in treating metastatic colorectal cancer.
On April 9, the status of the study on ClinicalTrials.gov notes that recruitment has been suspended, at least temporarily, in the randomized, multi-center, open-label clinical trial, which was sponsored by Roche.
The halt came after an independent data monitoring committee found that there had been three deaths in the group given the Tecentriq and Cotellic. Two of the deaths resulted from the continued progression of colorectal cancer, and the third death came from cardiogenic sock, the committee found. A fourth death was reportedly unrelated to the study.
Originally, the study, known as Phase II MODUL, aimed to include 1,400 patients in a trial that combined the two drugs to treat metastatic colorectal cancer. While patients who are taking the drugs as part of the study can continue to do so, however, no new patients are being recruited.
Roche reported to investors that the study has not uncovered any new safety signals, but that the cardiogenic shock case was believed to be treatment related.
Tecentriq (atezolizumab) is approved for the treatment of metastatic non-small cell lung cancer in patients where the disease has progressed after or during chemotherapy.
Cotellic (cobimetinib) is a drug developed by Exelixis and Roche subsidiary Genentech for the treatment of metastatic or unresectable melanoma.
It is unclear whether Roche will look to restart the trial anytime soon.