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FDA grants breakthrough therapy designation to Toca 511 and Toca FC for high-grade glioma
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The FDA granted breakthrough therapy designation to Toca 511 and Toca FC for the treatment of recurrent high grade glioma, according to the drugs’ manufacturer.
Toca 511 (Tocagen), an investigational injectable retroviral replicating vector, and Toca FC (Tocagen) — an investigational, orally administered, extended-release version of 5-fluorocytosine — are combined to directly kill cancer cells and immune-suppressive myeloid cells, according to a Tocagen-issued press release. This leads to activation of the immune system against cancer.
An estimated 14,000 people in the United States will be diagnosed with high-grade gliomas this year. The most common forms are glioblastoma and anaplastic astrocytoma.
Standard therapy consists of surgery followed by radiation and chemotherapy. However, most patients experience recurrence, and median survival after recurrence is 7 to 9 months.
“Receiving breakthrough therapy designation from the FDA for recurrent high-grade glioma, the first time it has been granted for this type of brain cancer, highlights the urgent need for new treatment options for this deadly disease,” Marty Duvall, CEO of Tocagen, said in a company-issued release.
The combination is under investigation in the international, randomized phase 2/phase 3 Toca 5 trial, which includes patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection. Enrollment of the phase 2 portion of the trial is complete, and topline results are anticipated in the first half of 2018.
The FDA previously granted fast track designation to Toca 511 & Toca FC for the treatment of recurrent high-grade glioma.
The agency based its breakthrough designation on data from three phase 1, ascending-dose clinical trials of Toca 511 & Toca FC that included 126 patients with recurrent brain cancer. The findings included safety data, patient survival data, and data on durable, complete or partial tumor shrinkage determined by independent radiology review.
Preclinical data also supported a novel immunological mechanism of action involving the depletion of immune-suppressive myeloid cells in the tumor microenvironment, according to the press release.
“Based on the encouraging safety and efficacy data we have seen to date, advancing the development of Toca 511 & Toca FC continues to be our team’s top priority,” Duvall said. “We look forward to working closely with the FDA to expedite development and review of the product candidate and related activities.”