Tocagen announced the Toca 5 Phase 3, randomized, multi-center clinical trial evaluating Toca 511 & Toca FC in patients with recurrent high grade glioma (HGG) undergoing resection missed the primary endpoint of overall survival compared to standard of care treatment (11.1 months median compared to 12.2 months, HR=1.06, p=0.6154). In addition, all secondary endpoints showed no meaningful difference between the arms of the trial. The safety, tolerability and adverse event profile of Toca 511 & Toca FC was as expected for this patient population.
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Further analysis of the Toca 5 trial data is currently underway and presentation of the results is planned at an upcoming medical conference.
"Recurrent brain cancer represents a very high unmet medical need and patients with this disease have very few treatment options," said Marty Duvall, chief executive officer of Tocagen. "While the Toca 5 trial results are disappointing, we will be conducting a thorough analysis of the data including molecular analyses and pre-planned subgroups. In addition, we will be conducting an operational review. We sincerely appreciate the exceptional support from patients and their families as well as patient advocates, physicians and our employees who have been committed to the rigorous study of Toca 511 & Toca FC in the Toca 5 trial."