Disaster for Tocagen

A week ago Tocagen’s chief executive voiced the hope that even if its recurrent glioma project, Toca 511 & Toca FC, missed statistical significance in the Toca-5 trial, the data might still show a clinically meaningful effect and hence permit filing. In the event, the drug turned out to be worse than control, with overall survival being 11.1 months versus 12.2 months with standard of care (HR=1.06, p=0.6154). All the secondary endpoints were missed as well. This being Tocagen’s lead project and the only one to which the sellside had assigned sales forecasts, the company has been hit hard, with the 82% fall in its share price conferring a market cap of less than $19m, well below the company’s cash balance of $68m at the end of the second quarter. Tocagen promised various further examinations of the Toca-5 data, including molecular analyses and pre-planned subgroups, and will wait for these results before deciding whether to go ahead with the phase III trial in treatment-naïve glioblastoma patients that had been planned for this autumn. The real question, though, is how Toca 511 & Toca FC flunked so badly having previously survived two futility analyses.