- Target patient population for
regulatory submissions finalized: Patients with low
PD-L1, in contrast to current checkpoint inhibitors
which work best with high PD-L1.
- Addressing unmet need in
~145,000 head and neck cancer patients per year worldwide.
- Routine cancer screening
tests can readily identify patients for Multikine upon
diagnosis.
- Increased 5-year survival and risk of
death cut in half in the target population treated with Multikine
vs control, 28% 5-year absolute survival advantage (73%
vs 45%, p=0.0015), hazard ratio 0.35 (95% CIs [0.18, 0.66], Wald
p=0.0012)
- Plan to seek immediate approval for
commercial distribution without having to wait for
completion of a confirmatory study in this target population
- Pre-application regulatory filings
recently submitted in the UK and Europe with additional
filings planned in the U.S. and Canada
CEL-SCI Corporation (NYSE American: CVM) today announced that it
has finalized the selection criteria for the head and neck cancer
target population to be treated with the Company’s immunotherapy
drug Multikine (Leukocyte Interleukin, Injection). Five-year
survival in the target population was 73% alive for
Multikine-treated patients vs only 45% alive in the control who did
not receive Multikine, with the five-year risk of death cut in half
for Multikine-treated subjects in the target population versus the
control. These data, which are statistically significant and
accompanied by strong hazard ratios, are a crucial achievement on
the path for the approval of Multikine. CEL-SCI presented the data
for the first time at the European Society for Medical Oncology
(ESMO) Congress in Spain on October 22, 2023. The selection
criteria for this target population were developed based on the
completed Phase 3 randomized controlled trial, advice from
regulators, and advice from physician consultants associated with
the University of California San Diego Cancer Center and Yale
Medical School, recognized as among the nation’s most esteemed
immuno-oncologists in head and neck cancer.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20231023240624/en/
Graph1: From CEL-SCI’s 2023 ESMO Poster
(Graphic: Business Wire)
Patients within this Multikine target population can be readily
identified upon diagnosis with tests
that physicians routinely use in cancer screening—another crucial
achievement towards making Multikine available for use, as it is
given immediately after diagnosis and before any other treatment.
Working with regulators, CEL-SCI can now write an appropriate
approval label defining Multikine’s target population, which is
supported by strong positive data from the Phase 3 trial. The
target population is estimated to cover ~145,000 advanced primary
head and neck cancer patients globally per year.
The final Multikine selection criteria are:
- No involvement of disease in the lymph nodes (“N0”) and no
extracapsular spread of the tumor, as confirmed using PET-CT/MRI
imaging, and
- Low PD-L1 tumor expression (defined as tumor proportion score
< 10).
CEL-SCI’s ESMO poster reports three major new advancements
supporting Multikine’s approvability:
- First, Multikine is most effective in patients having
tumors with low PD-L1 expression, consisting of about 70% of the
study population. (It should be noted that immune checkpoint
inhibitors like Keytruda and Opdivo appear to work best in patients
with tumors having high PD-L1 expression).
- Second, the Multikine target population can now be
readily identified upon diagnosis, prior to surgery, using tests
that physicians routinely use in cancer screenings.
- Third, Multikine patients in the target population saw a
significant increase in 5-year overall survival, from 45% for
control patients who did not receive Multikine to 73% for
Multikine-treated patients, shown in graph 1 above.
A 28% 5-year absolute survival advantage (73% vs 45%,
p=0.0015), hazard ratio 0.35 (95% CIs [0.18, 0.66], Wald
p=0.0012). The p-value of 0.0015 makes these results strongly
significant as a statistical matter. The hazard ratio for Multikine
vs control was 0.35, meaning that the Multikine-treated patients
had, on average, about 65% lower risk of death at any given time.
CEL-SCI is not aware of any head and neck cancer therapy that has
shown such a large 5-year survival benefit. In addition, the hazard
ratio’s “95% confidence interval” upper bound was 0.66, which
supports CEL-SCI’s confidence that a confirmatory trial of
Multikine in the target population would likely be a success. These
results and statistics support CEL-SCI’s confidence that the data
should be sufficient for requesting immediate approval for
Multikine to treat these patients who currently have an unmet need
for better outcomes.
Another finding presented at ESMO is also very important because
it predicts improved survival. This finding refers to pre-surgery
disease downstaging, which is when the physician assesses a lower
stage of disease after Multikine therapy compared to before
Multikine therapy. Graph 2 above clearly indicates that
Multikine-treated patients with downstaging (improved disease, the
green top line) have much better survival. This data is strongly
significant as a statistical matter, with a p-value below
0.0002.
Geert Kersten, Chief Executive Officer of CEL-SCI, said: “We are
now able to identify upon diagnosis
which patients are most likely to have pre-surgery responses to
Multikine and improved survival, as seen in the new ESMO data. This
is a new sign of hope for head and neck cancer patients and a
critical milestone for Multikine towards achieving regulatory
approval. Because Multikine is a neoadjuvant (pre-surgical)
immunotherapy, identifying patients who benefit from Multikine upon
diagnosis was very difficult, and we welcomed the assistance of
regulators and expert physician consultants to help us. With this
success announced at ESMO, we are eager to present these new data
to regulators.”
John Cipriano, Senior VP of Regulatory Affairs at CEL-SCI, said:
“Patients with this disease have a clear unmet medical need for
better outcomes. Multikine’s demonstrated effects in the new
intended target population are overwhelmingly large and strong as a
statistical matter and support the observed Multikine efficacy.
While Multikine has not yet been tested prospectively in the new
target population, the Phase 3 data present a compelling case for
immediate patient access to Multikine because the Phase 3 study
results showed prospectively that
Multikine led to pre-surgical responses which in turn led to longer
life. Regulators understand that patients should not have to wait
before gaining access to these benefits, particularly given
Multikine’s safety profile and data that mechanistically and
empirically supports the target population definition. There are
specific pathways in Europe, the UK, Canada, and the U.S. for such
approvals, and we are currently working towards this goal. We filed
requests with the UK and European regulatory bodies within the past
month, and we intend to press forward with these new results in
Canada and the U.S. in the coming months. Therefore, we hope to
receive approval in the target population without having to wait
for completion of a confirmatory study.”
CEL-SCI’s Chief Scientific Officer, Eyal Talor, Ph.D., a
co-author of CEL-SCI’s ESMO presentation, provided more detail on
the data. “This year’s ESMO data presentation also relates to
pre-surgery disease downstaging, which occurs, for example, when
the disease stage goes down from Stage IV to Stage III during
Multikine treatment before surgery. In the overall Phase 3 study
population, we saw that patients with disease downstaging survived
longer than those without. Therefore, we concluded that Multikine
benefited patients who had downstaging before surgery. The target
population selection criteria are designed to capture as many
responder patients as possible, and indeed we saw a 35% rate of pre-surgical downstaging in the
Phase 3 study subjects who met these selection criteria when
treated with Multikine. This high rate of downstaging and tumor
responses from Multikine led to the increase in overall survival
seen in the target population and this is why the risk of death was
cut in half for Multikine-treated
patients as compared to control.”
Click here for a link to CEL-SCI’s ESMO 2023 poster presentation
entitled: “Tumor Node stage shift following Leukocyte Interleukin,
Injection (LI) neoadjuvant extends overall survival in
treatment-naïve locally advanced primary squamous cell carcinoma of
the oral cavity/soft palate.”
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 studied patients
who were newly diagnosed with locally 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 called neo-adjuvant. 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.
Multikine is designed to help the immune system “target” 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. CEL-SCI has completed a 928 patient Phase 3 clinical trial
in locally advanced primary head and neck cancer patients.
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, 2022. 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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231023240624/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
Cel Sci (AMEX:CVM)
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