UK-based Oxford BioMedica has discontinued its Phase III TRIST study of TroVax in renal cancer, as the trial's independent data safety monitoring board has warned it will not meet its primary efficacy endpoint.
Following the study's fourth interim review, the DSMB recommended that the trial continue, but that no further vaccinations take place with Oxford's novel therapeutic cancer vaccine, which is being developed in collaboration with Sanofi-Aventis. The company remains optimistic that the results of the study may still demonstrate a survival advantage for TroVax, though it admits it is unlikely that the trial data alone will support registration of the drug in renal cancer.
The firm is also still committed to a randomized, placebo-controlled Phase III trial of TroVax in patients with Stage II/III colorectal cancer who have had surgical resection of their primary tumors and been treated with adjuvant chemotherapy. It will enroll around 3,000 patients with the primary endpoint of three-year disease-free survival.
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