ZURICH (Reuters) – Roche’s immunotherapy Tecentriq failed a late-stage clinical trial in a form of urothelial cancer, the Swiss drugmaker said on Friday.
The study evaluating Tecentriq as an after-surgery monotherapy did not meet its primary endpoint of disease-free survival compared to observation in people with muscle-invasive urothelial cancer, Roche said.
Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.
“Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival,” said Levi Garraway, chief medical officer. “We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers.”
Tecentriq is already approved in the United States, European Union and other countries for treating various forms of non-small cell and small cell lung cancer, some kinds of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.
Roche has active Phase III studies for Tecentriq in early and advanced bladder cancer, plus an extensive development program for the medicine in several types of lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.
(Reporting by Michael Shields)