Tocagen has completed enrolling patients in the Phase lll Toca 5 trial around three months ahead of schedule.
The global, pivotal trial aims to examine the safety and efficacy of Toca 511 and Toca FC compared to standard of care for the treatment of patients undergoing resection for recurrent high-grade glioma (HGG), the most common and aggressive primary brain cancer.
Approximately 188,000 new cases of HGG are expected to be diagnosed this year across the globe.
HGG reappears in most patients after frontline treatment, and standard of care treatment usually offers an average survival of only seven to nine months.
Tocagen CEO Marty Duvall said: “Completing enrolment in Toca 5 is the latest example of our recent progress as we continue to execute against our goals.
“This important milestone also triggers the next milestone payment of $2m from ApolloBio, our licensor of Toca 511 & Toca FC within the greater China region.”
The randomised, multi-centre Toca 5 trial will be led by University of California, Los Angeles Neuro-Oncology Program director Timothy Cloughesy.
It has enrolled 380 patients, who will be randomised prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC or control treatment with one option of standard of care.
The trial’s primary endpoint is overall survival (OS).
Its secondary endpoints comprise durable response rate, durable clinical benefit rate, duration of durable response, as well as overall survival at 12 months.