- 5-year survival rate of 82.6% and 73% reduction in overall
risk of death (hazard ratio of 0.27) are the strongest Multikine
efficacy results reported to date, reflecting results in patients
who met the CEL-SCI confirmatory Registration Study target
population criteria and were deemed at low risk for recurrence,
therefore not recommended per NCCN guidelines to receive
chemotherapy post-surgery
- Data provide further evidence that the selection criteria
for CEL-SCI’s upcoming confirmatory Registration Study may yield
improved clinical outcomes
- Future advances in diagnostic technologies that improve
patient selection, such as PET scans (which will be used in the
confirmatory study), may further optimize patient selection and
Multikine’s already strong efficacy results from the current 5-year
Overall Survival at 73% up into the 82% range
- Clear unmet need: the 5-year survival rate remains below 50%
in locally advanced resectable head and neck cancer patients who
receive standard of care only
CEL-SCI Corporation (NYSE American: CVM) today reported
new data from its concluded Phase 3 study of Multikine® (Leukocyte
Interleukin, Injection)* that were presented at the European
Society for Medical Oncology (ESMO) 2024 Congress on Saturday,
September 14, 2024 in a poster titled “Prognostic significance of
diagnostic staging in treatment naïve, resectable locally advanced
primary oral cavity squamous cell carcinoma for neoadjuvant
Leukocyte Interleukin Injection immunotherapy”. This data is highly
relevant to CEL-SCI’s 212 patient confirmatory Registration Study
which has received the U.S. Food and Drug Administration’s (FDA)
go-ahead and is currently under preparation.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240916023296/en/
CEL-SCI’s Multikine® Increases Head and
Neck Cancer 5-Year Survival Rate to 82.6%. The graph on the right
side (n=79) demonstrates that the target low risk population had a
5-year survival rate of 82.6% when treated with Multikine (n=38)
vs. 47.3% when treated with standard of care alone (n=41).
(Graphic: Business Wire)
Summary of Phase 3 Study: Multikine-treated patients who were
recommended treatment of surgery and radiotherapy had a nearly
4-year survival benefit over control group
As previously reported, CEL-SCI’s completed Phase 3 study of 923
patients showed that newly diagnosed head and neck cancer patients
who were deemed at low risk for recurrence after surgery (and
therefore recommended to receive only radiotherapy after surgery)
had a median overall survival (OS) benefit of 46.5-months, almost
4-years, over control patients. However, patients who were deemed
to be high risk for recurrence after surgery (and therefore
recommended to have chemotherapy added to the radiotherapy after
surgery) showed no survival benefit.
Upcoming FDA Confirmatory Registration Study
Since the completed Phase 3 study showed clear survival benefit
for some, but not all of the patients, the FDA requested that
CEL-SCI conduct a confirmatory Registration Study focusing on the
patients who showed the best survival benefit. Based on the data,
CEL-SCI determined this target population to be patients with newly
diagnosed locally advanced primary head and neck cancer with no
lymph node involvement and with low PD-L1 tumor expression.
Applying these selection criteria to the completed Phase 3 study of
923 patients resulted in the target population (n=114) having a 73%
survival at 5 years vs a 45% survival at 5 years for the control
patients, log rank p=0.0015. The hazard ratio was an exceptional
0.34, with a 95% confidence interval upper limit of 0.65; Wald
p=0.0012 and achieving a 66% reduction in the overall risk of
death.
Summary of New Data Presented at ESMO
The new data presented at ESMO includes a further analysis of
the 114 patients in the completed Phase 3 study who met these
target population selection criteria and form the basis for the
confirmatory study. Specifically, the new analysis focused on those
patients who were deemed low risk for recurrence (recommended to be
given only radiotherapy – but no
chemotherapy, per National Comprehensive Cancer Network
“NCCN” guidelines) following surgery (n=79) as opposed to the
selected patients who were deemed high risk for recurrence and who
were recommended to have chemotherapy added to their treatment
following surgery per the same guidelines (n=35).
While the overall survival benefit was clear and statistically
significant (log rank p=0.0015) for the entire target population
(n=114), the 79 patients who were recommended to receive only
radiotherapy benefited to an even greater degree from pre-surgery
treatment with Multikine than the group of 114 as a whole. This
target low risk population (n=38) had a 5-year overall survival of
82.6% when treated with Multikine vs. 47.3% when treated with
standard of care alone (n=41), without overlap in their respective
95% confidence intervals. More recent analysis for the target low
risk population (n=79) showed a hazard ratio of 0.27 (95% CI [0.12,
0.64], Wald p=0.0027) achieving a 73% reduction in overall risk of
death.
Management Commentary
“The additional data presented this weekend at ESMO 2024
provides further evidence that we have identified the target
population that has the greatest survival benefit from Multikine,
and that our study criteria can select for these patients upon
diagnosis, before surgery,” stated CEL-SCI CEO Geert Kersten. “It
makes sense that Multikine, an immunotherapy, provides even greater
benefit to patients who are not scheduled to receive chemotherapy
following surgery, given the known detriments of chemotherapy on
the immune system. Seeing more clearly than ever that patients who
were not recommended chemotherapy benefited the most begs the
question: What if, through better diagnostic technology such as the
PET scan, which we will be using in the confirmatory study,
resulting in better patient selection, we could treat only those
patients who are supposed to be treated with radiotherapy alone,
and not chemotherapy? The data
presented at ESMO is clear. This would lead to even better 5-year
survival, 82% instead of 73%.”
CEL-SCI’s CSO Eyal Talor, Ph.D. commented, “The criteria we
developed for selecting these locally advanced head and neck cancer
patients clearly showed that when patients were treated with
Multikine before surgery, they demonstrated an overall survival
advantage over control irrespective of whether these patients were
characterized as being at low- or high-risk for recurrence
following surgery. With this new analysis we also saw that patients
selected by these criteria who are deemed low risk for recurrence
post-surgery have a further improved survival outcome with a hazard
ratio of 0.27, which even is better than the already exceptional
hazard ratio of 0.34 seen for the overall selected population.”
The data were presented at ESMO 2024 by the study’s co-author
József Tímár MD, PhD, DSc, Professor Department of Pathology,
Forensic and Insurance Medicine at Semmelweis University in
Budapest, Hungary. Dr. Timar served as the Director of the Central
Pathology Laboratory for CEL-SCI’s IT-MATTERS Phase 3 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. 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.
Multikine (Leukocyte Interleukin, Injection), a true first-line
cancer therapy, has been dosed in over 740 patients and received
Orphan Drug designation from the FDA for neoadjuvant therapy in
patients with squamous cell carcinoma (cancer) of the head and
neck. Based on the very strong data from the completed randomized
controlled Phase 3 study, the FDA agreed to CEL-SCI’s target
patient selection criteria and gave the go-ahead to conduct a
small, focused, confirmatory Registration Study which will enroll
212 patients. CEL-SCI will enroll newly diagnosed locally advanced
primary head and neck cancer patients with no lymph node
involvement (determined via PET scan) and with low PD-L1 tumor
expression (determined via biopsy), representing over 100,000
patients annually.
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.
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, 2023. 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/20240916023296/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
Grafico Azioni Cel Sci (AMEX:CVM)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Cel Sci (AMEX:CVM)
Storico
Da Gen 2024 a Gen 2025
