- Data indicate significant overall survival (OS) benefit for
patients who received the Multikine® treatment regimen followed by
surgery and radiotherapy, but not for patients who had chemotherapy
added to the same treatment. The group showing significant survival
benefit (no chemotherapy) represents approximately 155,000 patients
per year globally, or about 40% of newly diagnosed advanced primary
head and neck cancer patients
- Patients treated with the Multikine treatment regimen
followed by surgery and radiotherapy(no chemotherapy) demonstrated
statistically significant OS (ITT, p=0.0236, HR= 0.68) advantage
vs. Standard of Care (SOC) alone; the 3-year survival advantage was
4.9% (72.4% vs 67.5%) and the 5-year survival advantage was 14.1%
(62.7% vs 48.6%) for the pre-defined population receiving no
chemotherapy. The Multikine treatment regimen followed by
surgery and radiotherapy(no chemotherapy) exhibited consistent OS
advantage. Median follow up time was greater than 7 years for
those last alive
- No safety issues were found for Multikine in the treated
population
- CEL-SCI plans to seek U.S. Food and Drug Administration
(FDA) approval for Multikine immunotherapy based on the
demonstrated significant OS benefit and favorable safety profile in
the unmet medical need head and neck cancer patients who received
Multikine, surgery and radiotherapy as part of their SOC
- The analysis of this separate group is expected to meet
regulatory requirements for FDA submission
- We believe the positive results of the study in this group
of patients mark the first-ever success of a neoadjuvant cancer
immunotherapy in advanced primary head and neck cancer
CEL-SCI Corporation (NYSE American: CVM) today announced
results from its 9.5 year pivotal Phase 3 study for its
immunotherapy Multikine® (Leukocyte Interleukin, Injection)* in the
treatment of advanced (stages III and IV) primary (previously
untreated) squamous cell carcinoma of the head and neck
(SCCHN).
In the intent to treat (ITT) advanced primary SCCHN patients the
study showed a statistically significant (p=0.0236, HR=0.68)
overall survival benefit of 14.1% with overall survival (OS) of
62.7% at 5 years for the group of patients receiving the Multikine
treatment regimen followed by surgery and radiotherapy therapy, but
not chemotherapy, as part of their standard of care (SOC)
treatment. The OS benefit increased over time. This group
represents about 155,000 patients worldwide, or about 40% of all
advanced primary head and neck cancer cases annually. Patients
treated with the same Multikine treatment regimen prior to surgery
and radiotherapy, but who also received chemotherapy, did not
exhibit this survival advantage. The chemotherapy, cisplatin, was
given intravenously and may have negated the survival benefit
imparted by Multikine immunotherapy in these patients.
This global trial enrolled 928 stage III and IVa patients
through 78 sites on 3 continents. The ITT population comprised of
923 patients, as 5 randomized patients were never treated. The two
main comparator arms of the study were: the Multikine treatment
regimen (Multikine plus CIZ: cyclophosphamide; indomethacin;
zinc-multivitamins) plus SOC vs. SOC alone. In each of these
comparator arms, patients were determined by pathology following
surgery to receive radiotherapy only or concurrent
radio-chemotherapy. These treatments were prescribed by the
protocol and are based on the NCCN (National Comprehensive Cancer
Network) Guidelines for the treatment of SCCHN patients. The data
were analyzed per the protocol and the Statistical Analysis
Plan.
Results for the patients who did not receive chemotherapy treatment as part of
their SOC are listed below. This is the group for which CEL-SCI
plans to seek FDA approval:
1) Patients treated with the Multikine
treatment regimen plus SOC vs. SOC alone had an overall survival
benefit of 14.1% at 5 years which exceeded the pre-defined 10%
overall survival benefit set out for the study population as a
whole. This result was statistically significant (ITT; p =0.0236,
HR=0.68) with a robust and durable duration effect exceeding 5
years.
2) The corresponding overall survival at 3
years and 5 years for each study treatment group was as follows:
Multikine treatment regimen (Multikine plus CIZ: cyclophosphamide;
indomethacin, zinc-multivitamins) plus SOC was 72.4% at 3 years,
62.7% at 5 years; Multikine (no CIZ) plus SOC was 78.8% at 3 years,
55.5% at 5 years. SOC alone was 67.5% at 3 years, 48.6% at 5 years.
The primary survival comparison was pre-defined only between the
first and last groups.
3) The OS advantage increased over time and
was evident from the inception of the study participation for this
group of patients through the end of the follow up period with a
median follow up time greater than 7 years for those still
alive.
4) No safety issues for Multikine were found
during or as a result of its administration, including no late
effects, in the overall treated patient population.
When the complete study population to which the Multikine
treatment regimen was administered (i.e., the combined lower risk
(no chemotherapy) and higher risk (with chemotherapy added)) was
compared to control, the study did not achieve its primary endpoint
of a 10% improvement in overall survival. However, the OS benefit
of 14.1% at 5 years for the lower risk subgroup (no chemotherapy)
exceeded the 10% OS benefit set out for the study population as a
whole. In addition, as the OS results for the lower risk of
recurrence patients (no chemotherapy) are significant (two-sided
p=0.0236, HR=0.68) and the effect is robust, durable and increasing
over time, CEL-SCI plans to seek FDA approval for Multikine cancer
immunotherapy in this underserved patient population. This
indication represents a dire unmet medical need with the last FDA
approval being many decades ago. CEL-SCI has Orphan Drug
designation from the FDA for the neoadjuvant therapy in patients
with squamous cell carcinoma of the head and neck – the patient
population treated in this Phase 3 study.
The analysis of this separate group is expected to meet
regulatory requirements for FDA submission based on the protocol
and Statistical Analysis Plan, which were prospectively concluded
before database lock and unblinding.
Geert Kersten, Chief Executive Officer of CEL-SCI remarked,
“Multikine demonstrated a significant survival benefit in the group
whose standard of care did not include chemotherapy and a favorable
safety profile across the entire patient population. Based on this
landmark study data, we intend to seek FDA approval for what could
become the first treatment in newly diagnosed advanced primary head
and neck cancer in many decades. If approved, Multikine would
address the needs of approximately 155,000 patients diagnosed
annually worldwide who are currently slated for surgery plus
radiotherapy and would significantly increase their chances of
overall survival. Our aim with Multikine was to develop a treatment
that will extend survival, and clearly this has been achieved in
this patient population. In addition, we wanted to develop a
treatment that does not add toxicity and does not make other cancer
treatments more difficult to bear. We appear to have achieved this
goal as well. We are grateful to all the patients and their
families who volunteered to participate in the world’s largest and
most rigorous Phase 3 study in advanced primary head and neck
cancer. We are confident that the robust overall survival benefit
shown in this pivotal study along with the safety profile of
Multikine clearly demonstrates the benefit of neoadjuvant
immunotherapy in this patient population and may lead to a new way
to treat advanced primary head and neck cancer.”
Dr. Eyal Talor, Chief Scientific Officer of CEL-SCI and the
developer of Multikine commented, “These data, combined with what
we know of Multikine’s mechanism of action, demonstrate Multikine’s
potential to impart long term overall survival advantage and a
beneficial effect on the anti-tumor immune response in patients who
have not been treated with chemotherapy (cisplatin) which is known
to be highly toxic. In patients not indicated to receive
chemotherapy as part of their standard of care, treatment with
Multikine neoadjuvant regimen demonstrated a statistically
significant, robust and durable overall survival benefit. The data
possibly indicate that the Multikine treatment regimen is capable
of altering the course of disease in this population. Perhaps most
impressive in the Multikine treated group not receiving
chemotherapy was the fact that the overall survival benefit
imparted by Multikine increased over time as compared to overall
survival in control, suggesting that the Multikine immunotherapy
neoadjuvant treatment stands to add great benefit to the intent to
cure - current standard of care.”
About Multikine
Multikine (Leukocyte Interleukin, Injection) is an
investigational cancer immunotherapy that is known to contain 14
natural human cytokines, the body’s immune system regulators
including interleukins, interferons, chemokines, and colony
stimulating factors which are elements of the body’s natural mix of
defenses against cancer and other diseases. A patented,
mass-produced, off the shelf and ready to use non-autologous
biological product, Multikine is manufactured using a proprietary
process following Good Manufacturing Practice (GMP) requirements
from Source Leukocytes, an FDA licensed product, at CEL-SCI’s
manufacturing facility near Baltimore, Maryland.
About Head and Neck Cancer
Approximately 650,000 new cases of head and neck cancer are
diagnosed each year globally, of which approximately 60,000 are in
the U.S. and 105,000 in Europe. Head and neck cancer represents 6%
of all cancers and leads to 300,000 deaths annually. Advanced
(stages III and IV) primary (previously untreated) squamous cell
carcinoma of the head and neck represent approximately 386,000
cases per year and about 40% of these, or approximately 155,000,
are patients diagnosed at lower risk for recurrence and therefore
are given only radiotherapy following surgery as part of their
standard of care, and no chemotherapy.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while
it is still intact should provide the greatest possible impact on
survival. Therefore, in the Phase 3 study CEL-SCI treated patients
who are newly diagnosed with advanced primary squamous cell
carcinoma of the head and neck with the investigational product
Multikine first, BEFORE they received surgery and radiotherapy or
surgery plus concurrent radiotherapy and chemotherapy (the current
standard of care for these patients). This approach is unique. Most
other cancer immunotherapies are administered only after
conventional therapies have been tried and/or failed. Multikine
(Leukocyte Interleukin, Injection), received Orphan Drug
designation from the FDA for neoadjuvant therapy in patients with
squamous cell carcinoma (cancer) of the head and neck. CEL-SCI
believes that this Phase 3 study is the largest Phase 3 study in
the world for the treatment of advanced primary head and neck
cancer.
Multikine is designed to help the immune system “see” the tumor
at a time when the immune system is still relatively intact and
thereby thought to be better able to mount an attack on the tumor.
The Phase 3 study was started in early 2011 and was fully enrolled
with 928 patients in September 2016. To prove an overall survival
benefit, the study required CEL-SCI to wait until at least 298
(deaths) events had occurred among the two main comparator groups.
This study milestone occurred in late April 2020 and database lock
occurred in December 2020.
The Company’s LEAPS technology is being developed for rheumatoid
arthritis and as a potential treatment for COVID-19 infection. The
Company has operations in Vienna, Virginia, and near/in Baltimore,
Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. When used in this press release, the words "intends,"
"believes," "anticipated," "plans" and "expects," and similar
expressions, are intended to identify forward-looking statements.
Such statements are subject to risks and uncertainties that could
cause actual results to differ materially from those projected.
Such statements include, but are not limited to, statements about
the terms, expected proceeds, use of proceeds and closing of the
offering. Factors that could cause or contribute to such
differences include, an inability to duplicate the clinical results
demonstrated in clinical studies, timely development of any
potential products that can be shown to be safe and effective,
receiving necessary regulatory approvals, difficulties in
manufacturing any of the Company's potential products, inability to
raise the necessary capital and the risk factors set forth from
time to time in CEL-SCI's filings with the Securities and Exchange
Commission, including but not limited to its report on Form 10-K
for the year ended September 30, 2020. The Company undertakes no
obligation to publicly release the result of any revision to these
forward-looking statements which may be made to reflect the events
or circumstances after the date hereof or to reflect the occurrence
of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark
that CEL-SCI has registered for this investigational therapy, and
this proprietary name is subject to FDA review in connection with
the Company's future anticipated regulatory submission for
approval. Multikine has not been licensed or approved for sale,
barter or exchange by the FDA or any other regulatory agency.
Similarly, its safety or efficacy has not been established for any
use.
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version on businesswire.com: https://www.businesswire.com/news/home/20210628005472/en/
COMPANY CONTACT: Gavin de Windt CEL-SCI Corporation (703)
506-9460
MEDIA CONTACT: John F. Kouten JFK
Communications, Inc. 609-241-7352 jfkouten@jfkhealth.com
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