SAN DIEGO, Nov. 22, 2019 /PRNewswire/ -- Tocagen Inc.
(Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy
company, today announced presentation of the full results from the
Toca 5 Phase 3 trial evaluating Toca 511 & Toca FC in patients
with recurrent high grade glioma (HGG) at the Society for
Neuro-Oncology (SNO) Annual Meeting. The data were presented on
behalf of the Toca 5 clinical investigators by Timothy Cloughesy, M.D., professor of neurology
and director of the neuro-oncology program at the University of California, Los Angeles and principal
investigator for the Toca 5 trial.
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.
Results
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 Michael A. Vogelbaum, M.D.,
Ph.D., program leader of neuro-oncology and chief of neurosurgery
at the Moffitt Cancer Center, at the Society for Neuro-Oncology and
Society for CNS Interstitial Delivery of Therapeutics' 3rd Joint
Conference on Therapeutic Delivery to the CNS. Data indicated that
the immunological profile at baseline was well balanced between the
two arms of the trial. In addition, data showed that patients in
the second recurrence, IDH1 mutations and AA subgroups had a more
robust immune profile prior to treatment. These data suggest that
patients within these subgroups may have been favorably predisposed
to generate anti-tumor immune responses.
"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 Marty Duvall,
chief executive officer of Tocagen. "We have submitted the data to
the FDA and anticipate providing an update once we have more
clarity on potential next steps for our recurrent brain cancer
program in the coming months."
Copies of Dr. Cloughesy's and Dr. Vogelbaum's presentations are
available on Tocagen's website.
About Tocagen
Tocagen is a clinical-stage,
cancer-selective gene therapy company developing first-in-class,
broadly applicable product candidates designed to activate a
patient's immune system against their own cancer. Tocagen plans to
evaluate its lead investigational product candidate, Toca 511 &
Toca FC, in a Phase 2/3 trial for patients newly diagnosed with
glioblastoma, sponsored by the NCI and conducted by NRG Oncology,
and a Phase 1 trial in patients with non-muscle invasive bladder
cancer. Tocagen is advancing preclinical programs from its
versatile gene therapy platform that represents a new approach in
cancer immunotherapy. For more information about Tocagen, visit
www.tocagen.com.
Forward-Looking Statements
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
the United States and foreign
countries; and our estimates regarding expenses, future revenue and
capital requirements. These and other risks and uncertainties are
described more fully under the caption "Risk Factors" and elsewhere
in Tocagen's filings and reports with the United States Securities
and Exchange Commission. All forward-looking statements contained
in this press release speak only as of the date on which they were
made. Tocagen undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made.
Media Contact:
Carolyn Hawley
Canale Communications
(619) 849-5382
carolyn@canalecomm.com
Investor Contact:
Pete Rahmer
Endurance Advisors
(415) 515-9763
prahmer@enduranceadvisors.com
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