CEL-SCI’S Phase 3 Data Presented at ESMO 2022: Neoadjuvant Multikine Achieved Groundbreaking Tumor Response & Extended Overall Survival in Locally Advanced Head and Neck Cancer
12 Septembre 2022 - 3:00PM
Business Wire
- Poster presentations by Dr. Philip Lavin, a biostatistician
for 80 FDA approvals/clearances, and Dr. József Tímár, Professor
and Director of the Central Pathology Laboratory at Semmelweis
University
- View the posters here: LINK
CEL-SCI Corporation (NYSE American: CVM) today announced
two poster presentations were delivered at the European Society for
Medical Oncology (EMSO) annual Congress on September 10, 2022 in
Paris, France. Data presented were from the Company's pivotal Phase
3 study, the largest study ever conducted in newly diagnosed
locally advanced squamous cell carcinoma of the head and neck.
Poster Presentation: Early response to Neoadjuvant Leukocyte
Interleukin Injection (LI) immunotherapy extends overall survival
(OS) in locally advanced primary squamous cell carcinoma (SCC) of
the head & neck (HN): the IT-MATTERS Study
(Clinicaltrials.gov NCT01265849)
Summary of findings presented by Dr. Philip Lavin:
- Early tumor response (early response) to neoadjuvant
Multikine-Treatment is noted before surgery (occurring at median 5
weeks post-randomization) adding credibility to the isolated impact
of early treatment
- Early response provides a positive signal to both patients and
care providers (early in the treatment course)
- Early response was noted only in the Multikine* (Leukocyte
Interleukin Injection) treatment groups and not in the control
group
- Early response occurs in both the Lower Risk and Higher Risk
groups for recurrence (Risk as defined per NCCN Guidelines)
- Early response is prognostic and predictive for overall
survival in:
- The overall population; and
- The Lower Risk population
- Benefit was also seen in Multikine-treated Lower Risk
non-responders
Dr. Lavin commented, “The IT-MATTERS study is groundbreaking by
having achieved 45 RECIST documented neoadjuvant responses
including 5 complete responses confirmed at surgery by pathology.
All responses were limited to the Multikine treatment groups, which
is a 1 in 100 billion chance event. Response mattered; the overall
survival was >3x longer for responders vs non-responders.”
Dr. Lavin is a well-known biostatistician with a long history
supporting clinical trials for product registrations,
reimbursements, and public health advancement. He has served as the
Lead Biostatistician for 80 FDA approvals including 43 PMAs, 23
NDAs, 8 510Ks, 4 BLAs, and 2 de novos with more pending. These
approvals have resulted in >$25B in increased valuations. Dr.
Lavin also advised the FDA from 1983 through 2015 on product
approvals and public policy matters as a Special Government
Employee.
Poster Presentation: Histopathology (HP) biomarkers confirm
Leukocyte Interleukin Injection (LI) treatment (Tx) outcome in
naïve locally advanced primary head & neck squamous cell
carcinoma (SCCHN) the IT-MATTERS Study (Clinicaltrials.gov
NCT01265849)
Summary of findings presented by Dr. József Tímár:
- Pre-defined markers, ratios, and combinations derived from
Multikine treated tumor samples at surgery contribute to Multikine
efficacy for all three efficacy endpoints (OS), progression free
survival (PFS), and local regional control (LRC)
- Broad representation of markers, ratios, and combinations
overall and for Lower Risk (LR) for the OS, PFS, LRC efficacy study
endpoints
- There were 61 (21.9%) favorable overall and 54 (19.4%)
favorable Lower Risk treatment group outcomes (much beyond 2.5%
chance) and only a total of five instances (1.9%) [all High Risk]
having unfavorable treatment group outcome (within the realm of
chance)
- These biomarkers were prognostic for superior efficacy of the
post surgery adjuvant radiotherapy as compared to adjuvant
chemoradiotherapy
- The results support the Lower Risk treatment advantage (0.68
HR, Wald p<0.05) significantly favoring Multikine+CIZ+ SOC vs
SOC alone
Dr. Timar stated, “Biomarker analysis indicated that low
expression of tumor cell PDL1, high density of most of the immune
cell types (CD4, CD8, T cells, B cells, macrophages), high CD4/CD8
and low CD8/FOXP3 ratios as well as high density of CTLA4 and CD25
positive cells, were all predictive of Multikine efficacy in the
Multikine treated population.”
József Tímár MD, PhD, DSc, is a prominent and highly respected
pathologist. He is Professor Department of Pathology, Forensic and
Insurance Medicine at Semmelweis University in Budapest, Hungary,
and served as the Director of the Central Pathology Laboratory for
the IT-MATTERS study. With 174 peer reviewed studies published, Dr.
Timar is a founding editor, editor in chief, or a member of the
editorial board of four oncology journals. He is the recipient of a
dozen honors and awards for excellence in cancer research and
teaching.
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.
The Company’s LEAPS technology is being developed for rheumatoid
arthritis. 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, 2021. 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/20220912005376/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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