Roche Holding AG said a late stage trial of its cancer drug Tecentriq, combined with Exelixis Inc.'s Cotellic, in a type of colorectal cancer failed to meet its main goal.
Statistically significant results from a phase 3 study, dubbed IMblaze370, did not help patients live longer with the disease compared to Bayer AG's Stivarga.
The study evaluated previously treated patients with difficult-to-treat colorectal cancer that has grown outside the organ or has spread across the body. The patients were either intolerant to at least two systemic chemotherapy regimens or had their disease progress after the chemotherapy treatments.
Tecentriq is part of a class of immune system-boosting drugs known as checkpoint inhibitors. Inhibitor drugs target immune checkpoints such as PD-L1 and CTLA-4 to prevent cancer cells from downregulating and hiding from the body's immune system.
The Swiss drugmaker said over 95% of patients in the IMblaze370 trial have microsatellite stable tumors — cancers with chromosomal instability and are harder to cure. Available data suggests that checkpoint inhibitors as single treatments have not shown efficacy for these types of tumors.
Cotellic, also known cobimetinib, is being developed under a worldwide collaboration agreement between California-based Exelixis and Genentech Inc., a unit of Roche.
Roche is studying Tecentriq, both as a single therapy and in combination with other drugs, for treating lung, bladder, kidney, skin and breast cancers, among other indications.