Roche’s Tecentriq meets primary endpoint in Phase 3 bladder cancer trial
pharmafile | August 5, 2019 | News story | Sales and Marketing | Cancer, Roche, bladder cancer, immunotherapy, oncology, tecentriq
Roche has said its immunotherapy drug Tecentriq (Atezolizumab), when used in combination with platinum-based chemotherapy, significantly reduced the risk of disease worsening and death in a Phase 3 trial of patients with bladder cancer.
Roche’s immunotherapy, in combination with chemotherapy, met its primary endpoint in the IMvigor130 Phase 3 trial after significantly reducing the chance of disease worsening or death in people with previously untreated, locally advanced or metastatic urothelial carcinoma (mUC) compared with chemotherapy alone.
The drug’s safety profile was consistent with the known safety profiles of each of the individual medicines, while no new safety signals were identified with the combination of the two drugs.
“IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer, an aggressive disease with high unmet need,” said Dr Sandra Horning, Chief Medical Officer and Head of Global Product Development.
“These results support our broad clinical development programme for Tecentriq in bladder cancer, as well as our approach of combining immunotherapy with chemotherapy or other medicines to improve patient outcomes, and we look forward to discussing them with health authorities.”
As of yet, Tecentriq is the only immunotherapy approved in bladder cancer. There are currently four Phase 3 studies evaluating Tecentriq, either alone or in combination, as a treatment for bladder cancer. Roche is also investigating the drug as a treatment for lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers in a series of Phase 3 trials.
Louis Goss
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