OSE Immunotherapeutics Announces: Positive Phase 3 Data from its Cancer Vaccine in Lung Cancer Patients with Resistance to Previous Immunotherapy Published in Annals of Oncology
11 September 2023 - 6:00PM
Business Wire
Leading medical journal highlights peer-reviewed, randomized
phase 3 clinical results with Tedopi® off-the-shelf T-cell
epitope-based cancer vaccine monotherapy compared to chemotherapy
in advanced non-small cell lung cancer (NSCLC) patients in
secondary resistance to immune checkpoint inhibitors (ICI), with
statistically significant and clinically meaningful data
on:
- Overall survival, - Safety, - and Quality of
Life.
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE)
(Paris:OSE) today announced the peer-reviewed publication in
Annals of Oncology* of the randomized Phase 3 clinical trial
(Atalante-1**) on T-cell epitope cancer vaccine Tedopi® in HLA-A2
positive patients with advanced or metastatic NSCLC in monotherapy
in third line NSCLC with secondary resistance to immune checkpoint
inhibitors (ICI).
Tedopi® is a novel T-cell epitope-based cancer vaccine targeting
five tumor-associated antigens, an activating and differentiated
off-the-shelf immunotherapy expanding tumor specific T-lymphocytes
in HLA-A2 cancer patients. The article, titled “Randomized
Open-Label Controlled Study of Cancer Vaccine OSE2101 Versus
Chemotherapy in HLA-A2-positive Patients with Advanced Non-Small
Cell Lung Cancer with Resistance to Immunotherapy: ATALANTE-1”
features positive data from the randomized international Phase 3
study showing that novel cancer vaccine Tedopi® improves overall
survival with a better safety and quality of life profile in
monotherapy compared to chemotherapy in HLA-A2 positive patients
with advanced or metastatic NSCLC who have progressed at least 12
weeks after sequential treatment with chemotherapy and immune
checkpoint inhibitors (ICI).
Prof. Benjamin Besse, Director of Clinical Research at Gustave
Roussy Institute (IGR, Villejuif, France), and Principal
Investigator of the Atalante-1 clinical trial, commented: “Tedopi®
is the first cancer vaccine to demonstrate positive results on
survival in a randomized Phase 3 trial in advanced and metastatic
NSCLC cancer patients in 3rd line. A significant reduction of the
risk of death by 41% was achieved with a better safety profile and
a maintained quality of life. This study, conducted in patients
with secondary resistance to immunotherapy, compared Tedopi®
monotherapy with standard of care docetaxel or pemetrexed
chemotherapies. Further evaluation is clearly warranted in a second
line of treatment of advanced and metastatic NSCLC, to potentially
make this cancer vaccine available to hard-to-treat patients in
failure and with high medical needs.”
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, commented: “Tedopi® is the most advanced
therapeutic cancer vaccine in clinical development. These Phase 3
data, demonstrating the promising effects, have now been validated
in the internationally recognized journal ‘Annals of Oncology', a
major achievement for all involved so, in particular, we’d like to
thank warmly the investigators, the patients and their families for
their commitment. This Phase 3 positive monotherapy data and
moreover the recently announced positive Phase 1 and 2 results
using other personalized cancer vaccines in combination to treat
resected melanoma or pancreatic cancer patients, highlight the
promise of this new therapeutic class of vaccines. The clinical
value of our results, re-activating specifically the anti-tumor
immune responses, is particularly interesting in patients showing
immune escape from checkpoint inhibitors. The confirmatory pivotal
Phase 3 trial in preparation (first patient expected early 2024) is
planned to support the regulatory registration of Tedopi® in
secondary resistance to immune checkpoint inhibitors, this time in
second line NSCLC treatment.”
Main results of the first Phase 3 clinical trial of Tedopi®
in HLA-A2+ patients with NSCLC
This Phase 3 clinical trial has demonstrated a significant
therapeutic benefit in patients with secondary
resistance (1) to immune checkpoint inhibitors (ICI) defined as
patients with failure to platinum-based chemotherapy followed by a
minimum of 12 weeks ICI treatment (main analysis of the trial).
Tedopi® demonstrated a favorable benefit/risk ratio versus standard
of care (SoC) docetaxel or pemetrexed in advanced HLA-A2+ NSCLC
patients with secondary resistance to ICI.
The main results were:
Improved efficacy
1. Overall survival (primary endpoint) was statistically
significantly improved for Tedopi®: HR=0.59 (95% CI: 0.38, 0.91) in
favor of the Tedopi® arm, reduced risk of death by 41%. 44.4%
overall survival rate at 1 year with Tedopi® versus 27.5% with
chemotherapy. A clinically meaningful gain in median overall
survival of 3.6 months in favor of the Tedopi® arm with Tedopi® OS
at 11.1 months versus 7.5 months for SoC (p=0.017).
2. Post progression survival was also significantly longer in
the Tedopi® arm (7.7 months versus 4.6 months; p=0.004,
HR=0.46).
Improved safety profile and Quality of Life
- The ECOG performance status(2), of maintained general health
condition with time to ECOG deterioration was significantly longer
in the Tedopi® arm (9.0 months versus 3.3 months; p=0.006;
HR=0.43).
- A better quality of life was observed with Tedopi® (p= 0.04).
(Global health status: p=0.045; Role Functioning: p=0.025).
- A good tolerance profile of Tedopi® with fewer Severe Adverse
Events grade 3-5 (Tedopi® 38% vs SoC 68%, p<0.001). No Treatment
Emergent Adverse Effects of concern in the Tedopi® arm.
(1) Secondary resistance is defined as failure after a minimum
of 12 weeks of Immune checkpoint inhibitor given in sequential
chemotherapy - checkpoint inhibitors treatment (Kluger HM et al;
Journal for immunoTherapy of Cancer 2020 Defining tumor resistance
to PD-1 pathway blockade: recommendations from the first meeting of
the SITC Immunotherapy Resistance Taskforce) (2) The ECOG score is
a performance scale used to quantify the general health condition
of a patient. It is subdivided into 5 grades from 0 to 5, ranging
from fully active (0) to fully disabled, then to death (5).
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is a biotech company dedicated to
developing first-in-class assets in immuno-oncology and
immuno-inflammation.
The Company’s current well-balanced first-in-class clinical
pipeline includes:
- Tedopi® (immunotherapy activating tumor specific
T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is
the Company’s most advanced product; positive results from the
Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients
in secondary resistance after checkpoint inhibitor failure. Other
Phase 2 trials, sponsored by clinical oncology groups, of Tedopi®
in combination are ongoing in solid tumors.
- OSE-279 (anti-PD1): ongoing Phase 1/2 in solid tumors or
lymphomas (first patient included). OSE-279 is the backbone therapy
of the BiCKI® platform.
- OSE-127 - lusvertikimab (humanized monoclonal antibody
antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis
(sponsor OSE Immunotherapeutics); ongoing preclinical research in
leukemia (OSE Immunotherapeutics).
- FR-104/VEL-101 (anti-CD28 monoclonal antibody):
developed in partnership with Veloxis Pharmaceuticals, Inc. in
transplantation; ongoing Phase 1/2 in renal transplant (sponsor
Nantes University Hospital); Phase 1 ongoing in the US (sponsor
Veloxis Pharmaceuticals, Inc.).
- OSE-172/BI 765063 (anti-SIRPα monoclonal antibody on
CD47/SIRPα pathway) developed in partnership with Boehringer
Ingelheim in advanced solid tumors; positive Phase 1 dose
escalation results in monotherapy and in combination, in particular
with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing
clinical trial in combination with ezabenlimab alone or with other
drugs in patients with recurrent/metastatic head and neck squamous
cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC).
OSE Immunotherapeutics expects to generate further significant
value from its two proprietary drug discovery platforms, which are
central to its ambitious goal to deliver next-generation
first-in-class immunotherapies:
- BiCKI® platform focused on immuno-oncology (IO) is a
bispecific fusion protein platform built on the key backbone
component of anti-PD1 combined with a new immunotherapy target to
increase anti-tumor efficacy. BiCKI-IL-7 is the most advanced
BiCKI® candidate targeting anti-PD1xIL-7.
- Myeloid platform focused on optimizing the therapeutic
potential of myeloid cells in IO and immuno-inflammation (I&I).
OSE-230 (ChemR23 agonist mAb) is the most advanced candidate
generated by the platform, with the potential to resolve chronic
inflammation by driving affected tissues to tissue integrity.
Additional information about OSE Immunotherapeutics assets is
available on the Company’s website: www.ose-immuno.com
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Forward-looking statements
This press release contains express or implied information and
statements that might be deemed forward-looking information and
statements in respect of OSE Immunotherapeutics. They do not
constitute historical facts. These information and statements
include financial projections that are based upon certain
assumptions and assessments made by OSE Immunotherapeutics’
management in light of its experience and its perception of
historical trends, current economic and industry conditions,
expected future developments and other factors they believe to be
appropriate.
These forward-looking statements include statements typically
using conditional and containing verbs such as “expect”,
“anticipate”, “believe”, “target”, “plan”, or “estimate”, their
declensions and conjugations and words of similar import. Although
the OSE Immunotherapeutics management believes that the
forward-looking statements and information are reasonable, the OSE
Immunotherapeutics’ shareholders and other investors are cautioned
that the completion of such expectations is by nature subject to
various risks, known or not, and uncertainties which are difficult
to predict and generally beyond the control of OSE
Immunotherapeutics. These risks could cause actual results and
developments to differ materially from those expressed in or
implied or projected by the forward-looking statements. These risks
include those discussed or identified in the public filings made by
OSE Immunotherapeutics with the AMF. Such forward-looking
statements are not guarantees of future performance. This press
release includes only summary information and should be read with
the OSE Immunotherapeutics Universal Registration Document filed
with the AMF on May 2, 2023, including the annual financial report
for the fiscal year 2022, available on the OSE Immunotherapeutics’
website. Other than as required by applicable law, OSE
Immunotherapeutics issues this press release at the date hereof and
does not undertake any obligation to update or revise the
forward-looking information or statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20230911637065/en/
OSE Immunotherapeutics Sylvie Détry
sylvie.detry@ose-immuno.com
Nicolas Poirier Chief Executive Officer
nicolas.poirier@ose-immuno.com
French Media: FP2COM Florence Portejoie
fportejoie@fp2com.fr +33 6 07 768 283
OSE Immunotherapeutics (EU:OSE)
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