Study Achieves Progression-free Survival Endpoint with Statistical
Significance; Primary Endpoint of Overall Survival Not Statistically
Conference Call Today at 5:00 pm ET/2:00 pm PT
LOS ANGELES--(BUSINESS WIRE)--
ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT:IMUC)
announced that ICT-107, its dendritic cell-based vaccine, demonstrated a
statistically significant increase in progression-free survival (PFS) in
patients with newly diagnosed glioblastoma multiforme (GBM) in its
randomized, placebo-controlled phase II trial. A comparison of PFS
between ICT-107 and placebo showed a statistically significant
difference in the Kaplan-Meier (K-M) curves favoring ICT-107 (p=0.014
two-sided, hazard ratio (HR)=0.56) in the intent-to-treat population of
all 124 randomized patients. The difference in the median
progression-free survival times between ICT-107 and placebo favored
ICT-107 and was two months in duration. For the per-protocol population
(117 of 124 patients receiving at least four induction vaccinations),
the K-M comparison p-value improved in treated patients to 0.0074
two-sided (HR=0.53) and the difference in median progression-free
survival times increased to three months in favor of ICT-107.
The differences in the overall survival (OS) K-M curves did not reach
statistical significance in the intent-to-treat population (the primary
endpoint) or the per-protocol population, with p-values and HRs of
p=0.58 two-sided, HR=0.87, and p=0.40 two-sided, HR=0.79, respectively.
However, there were numerical differences in the median survivals
favoring ICT-107 of two months in the intent-to-treat population and
three months in the per-protocol population.
The OS analysis includes data on 67 events (patient deaths) out of a
possible 124, whereas the PFS analysis includes data from 103 events.
ImmunoCellular Therapeutics plans to continue following patients in this
trial to collect more mature OS data. In the matured data from the open
label, phase I trial, the Company observed a consistent benefit in both
PFS and OS compared with historical controls, and on this basis thinks
that it is possible that the primary OS benefit could be clarified as
the phase II data mature.
In this phase II study, ICT-107 was generally safe and well tolerated,
with no imbalance of adverse events between the active and placebo
GBM is the most common and aggressive primary cancer of the brain.
Patients with this disease have few therapeutic options; temozolomide is
currently the only FDA-approved systemic chemotherapy for newly
Patrick Wen, MD, Director of the Center for Neuro-Oncology at The Dana
Farber Cancer Institute and Professor of Neurology at Harvard Medical
School, and an investigator on this trial, said, "The progression-free
survival data look promising in this study. To my knowledge, this is the
first time a placebo-controlled immunotherapy trial in glioblastoma has
demonstrated a statistically significant improvement in a clinically
relevant measure, such as progression-free survival. We await additional
data to evaluate the effect on overall survival."
John Yu, MD, Founder, Chairman and Chief Scientific Officer of
ImmunoCellular Therapeutics, said, "We are quite pleased to see such a
strongly statistically significant result in PFS in this exploratory
trial, and believe that in conjunction with the indications of a
survival benefit, these results provide a strong medical rationale for
continued development of ICT-107 as a potential treatment for
glioblastoma. We look forward to discussing this important clinical
outcome, and what next steps, including a phase III trial, might entail,
with the FDA in an end-of-phase-II meeting."
Andrew Gengos, ImmunoCellular Therapeutics Chief Executive Officer,
said, "Although we missed the primary OS endpoint, it is encouraging
that the OS and PFS results are consistent and that most of the
predefined secondary endpoints in the OS subgroups numerically favor
ICT-107 over placebo, although none has reached statistical
significance. These phase II results, in conjunction with the phase I
results which have indicated the potential for long-term survival,
support our view that ICT-107 has a biological and clinically relevant
effect in GBM, and potentially may provide a long-term survival benefit.
We plan to analyze the results further in the coming weeks and learn
more with the goal of informing our next development and regulatory
steps. We want to thank the patients who participated in this trial, and
our trial site collaborators and dedicated clinical team for their high
ImmunoCellular anticipates presenting the results of the ICT-107 phase
II trial at an upcoming national scientific or medical forum.
About the ICT-107 Phase II Trial
The ICT-107 phase II trial is a randomized, double-blind,
placebo-controlled phase II study of the safety and efficacy of ICT-107
in newly diagnosed patients with glioblastoma multiforme following
resection and chemoradiation. ICT-107 is an intradermally administered
autologous vaccine consisting of the patient's dendritic cells pulsed
with six synthetic tumor-associated antigens: AIM-2, MAGE-1, TRP-2,
gp100, HER-2, IL-13Rα2. The control consists of the patient's unpulsed
A total of 124 patients were randomized at 25 clinical trial sites in
the US. One third of the patients or 43 patients were treated with
placebo (their own dendritic cells not exposed to antigen), and the
treatment arm included two thirds or 81 patients who received the
ICT-107 vaccine. All patients in the trial received standard-of-care
temozolamide. The regimen is four induction doses of ICT-107 after
chemoradiation, and then maintenance doses until the patient progresses.
The primary endpoint of the trial is OS, defined as the time from
randomization until date or death or the last date the patient is known
to be alive. Secondary endpoints include PFS, defined as the time from
randomization until the date of documented progressive disease or death,
whichever occurs first, or the last date the patient is known to be
alive and progression-free if progression or death is not observed.
Other secondary endpoints include the rates of OS and PFS at six months
after surgery, then assessed every three months until the end of the
study. Safety and immune response are additional secondary endpoints.
The phase II trial is powered at 80% to show a nine-month overall
survival benefit assessed after reaching 64 events.
Patients who have not yet progressed will continue in the trial until an
appropriate termination point can be determined.
For patient related information about the ICT-107 clinical program in
glioblastoma (brain cancer), please visit the ImmunoCellular website at www.imuc.com
and access the ICT-107 "Frequently Asked Questions." The email address
to contact the company directly is firstname.lastname@example.org.
Conference Call Today
ImmunoCellular is holding a conference call and webcast today at 5:00 pm
ET to discuss the ICT-107 phase II results. The call will be hosted by
Andrew Gengos, President and CEO.
(877) 853-5636 (toll-free)
Conference code: 23984187
(855) 859-2056 (toll-free)
Conference code: 23984187
(Replay available from Wednesday, December 11, 2013 at 8:00 pm ET
until Tuesday, December 17, 2013 at 11:59 pm ET.)
The conference call will contain forward-looking statements. Interested
parties who wish to listen to the webcast should visit the Investor
Relations, Events & Presentations section of ImmunoCellular's website at www.imuc.com.
The information provided on the teleconference and webcast is accurate
only at the time of the conference call, and ImmunoCellular will take no
responsibility for providing updated information except as required by
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage
company that is developing immune-based therapies for the treatment of
brain and other cancers. ImmunoCellular is conducting a phase II trial
of its lead product candidate, ICT-107, a dendritic cell-based vaccine
targeting multiple tumor-associated antigens for glioblastoma.
ImmunoCellular's pipeline also includes ICT-121, a dendritic cell
vaccine targeting CD133, and ICT-140, a dendritic cell vaccine targeting
ovarian cancer antigens and cancer stem cells. To learn more about
ImmunoCellular, please visit www.imuc.com.
Forward-Looking Statements for ImmunoCellular
This press release contains certain forward-looking statements that are
subject to a number of risks and uncertainties, including the risk that
ICT-107 can be further successfully developed or commercialized, the
outcome of the post-phase II meeting with the FDA and whether further
studies may confirm the successful PFS results to date. Additional risks
and uncertainties are described in IMUC's most recently filed quarterly
report on Form 10-Q and annual report on Form 10-K. Except as permitted
by law, IMUC undertakes no obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise. In this press release, you can identify
forward-looking statements by terms such as "may," "will," "should,"
"could," "would," "expect," "plan," "anticipate," "believe," "estimate,"
"project," "predict," "potential," "future," "intend," "certain," and
similar expressions intended to identify forward-looking statements. You
can identify forward-looking statements by terms such as "may," "will,"
"should," "could," "would," "expect," "plan," "anticipate," "believe,"
"estimate," "project," "predict," "potential," "future," "intend,"
"certain," and similar expressions intended to identify forward-looking
ImmunoCellular Therapeutics, Ltd.
Source: ImmunoCellular Therapeutics, Ltd.
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