Toca 5 Phase 3 Trial Results Presented at the Society for Neuro-Oncology Annual Meeting
Trial design and demographics
Toca 5 was a Phase 3 randomized trial of Toca 511 & Toca FC in patients with recurrent HGG, undergoing resection. The trial involved 67 sites globally and enrolled 403 patients. Patients were randomized 1:1 prior to surgical resection to receive either the Toca 511 & Toca FC regimen or standard of care (SOC) treatment (lomustine, temozolomide or bevacizumab). The primary endpoint of the trial was overall survival (OS) and secondary endpoints included durable response rate, durable clinical benefit rate, duration of durable response and overall survival at 12 months. Patients were stratified based on IDH1 mutation status, KPS and geographic region. The baseline demographics and disease characteristics of the study were well balanced in the intent to treat populations and the 26 pre-specified subgroups.
As previously announced, the trial did not meet the primary or secondary endpoints. The safety, tolerability and adverse event profile of Toca 511 & Toca FC was as expected for this patient population. In the ITT population, the median number of cycles of Toca FC was two and the median number of cycles across the SOC options ranged from two to four.
In a pre-planned subgroup analysis, subjects with second recurrence (N=60) showed a 57% risk reduction for death when treated with Toca 511 and Toca FC (21.82 months median OS compared to 11.14 months, HR=0.43, p=0.0162) representing an approximate doubling of survival. Further analysis of the second recurrence subgroup showed that patients with IDH1 mutations and anaplastic astrocytoma (AA), had the greatest survival benefit (HR=0.102, p=0.009). Second recurrence patients with IDH1 mutations and AA received a median of six cycles of Toca FC compared to a median of three cycles across the SOC options.
"The positive outcome for patients at second recurrence in the Toca 5 trial are compelling, despite the disappointment of the overall trial results," said Dr. Cloughesy. "Combined with an acceptable safety profile, these data support a potential opportunity to address the high unmet needs of this well-defined patient population and should inform any future development of the Toca 511 & Toca FC regimen."
In addition, molecular data from the Toca 5 trial were presented by
"We have conducted a thorough analysis of the Toca 5 data and a subgroup of patients appear to benefit from treatment with Toca 511 & Toca FC," said
Copies of Dr. Cloughesy's and Dr. Vogelbaum's presentations are available on Tocagen's website.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding any potential future development of Toca 511 & Toca FC or our plans to provide additional clarity on our recurrent brain cancer program in the coming months. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of our product candidate development activities and planned clinical trials; our ability to execute on our strategy; regulatory developments in
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