17.06.2024 15:00:07 - dpa-AFX: GNW-Adhoc: iTeos and GSK Initiate GALAXIES Lung-301 Phase 3 Study, Assessing Belrestotug and Dostarlimab in Previously Untreated, Unresectable Locally Advanced / Metastatic PD-L1 Selected Non-Small Cell Lung Cancer
WATERTOWN, Mass. and GOSSELIES, Belgium, June 17, 2024 (GLOBE NEWSWIRE) -- iTeos
Therapeutics, Inc. (Nasdaq: ITOS) ("iTeos"), a clinical-stage biopharmaceutical
company pioneering the discovery and development of a new generation of immuno-
oncology therapeutics for patients, and its development partner GSK, have
initiated the first, global Phase 3 registration study of belrestotug +
dostarlimab doublet versus placebo + pembrolizumab in patients with previously
untreated, unresectable, locally advanced or metastatic PD-L1 selected non-small
cell lung cancer (NSCLC).
"With the initiation of the first Phase 3 study for belrestotug, we are entering
a monumental stage in our journey to develop a world-leading oncology company.
Nearly 70% of patients with first-line PD-L1 high non-small cell lung cancer
rely upon a chemotherapy-free regimen. We believe belrestotug + dostarlimab are
poised to potentially advance the therapeutic regimen in this setting and
establish new benchmarks," said Michel Detheux, Ph.D., president and chief
executive officer of iTeos. "Based on our high-quality doublet exceeding its
pre-defined efficacy criteria for clinically relevant activity in an interim
assessment from the Phase 2 GALAXIES Lung-201 study, we believe initiating the
Phase 3 program with this patient population will serve as the foundation to our
broader strategy and marks our first step in building a franchise."
The randomized, double-blind, placebo-controlled, multicenter trial will enroll
approximately 1,000 patients with previously untreated, unresectable, locally
advanced or metastatic PD-L1 selected NSCLC in North America, South America,
Europe and Asia. The primary endpoints of the trial are progression free
survival and overall survival. In the GALAXIES Lung-301 trial, patients will be
randomized 1:1 to either an intravenous infusion of the belrestotug +
dostarlimab doublet or placebo + pembrolizumab.
In May 2024, iTeos announced an interim assessment of the Phase 2 GALAXIES Lung-
201 study of the belrestotug + dostarlimab doublet in previously untreated,
locally advanced, or metastatic PD-L1 selected NSCLC exceeded pre-defined
efficacy criteria for clinically relevant activity and showed an acceptable
safety profile in line with the TIGIT:PD-1 class. Clinically meaningful tumor
reduction was observed at every belrestotug + dostarlimab dose vs dostarlimab
monotherapy.
About iTeos Therapeutics, Inc.
iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the
discovery and development of a new generation of immuno-oncology therapeutics
for patients. iTeos Therapeutics leverages its deep understanding of tumor
immunology and immunosuppressive pathways to design novel product candidates
with the potential to restore the immune response against cancer. The Company's
innovative pipeline includes three clinical-stage programs targeting novel,
validated immunosuppressive pathways designed with optimized pharmacologic
properties for improved clinical outcomes, including the TIGIT/CD226 axis and
the adenosine pathway. iTeos Therapeutics is headquartered in Watertown, MA with
a research center in Gosselies, Belgium.
About Belrestotug (EOS-448/ GSK4428859A)
Belrestotug is an Fc active human immunoglobulin G1, or IgG1, monoclonal
antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based
inhibitory motif domains (TIGIT), an important inhibitory receptor which
contributes to the suppression of innate immune responses against cancer. As an
optimized high-affinity, potent anti-TIGIT mAb, belrestotug is designed to
enhance the antitumor response through a multifaceted immune modulatory
mechanism by engaging with TIGIT and Fc?R, a key regulator of immune responses
which induces cytokine release and antibody dependent cellular cytotoxicity
(ADCC). The therapeutic candidate is progressing in multiple indications in
collaboration with GSK.
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Forward-Looking Statements
This press release contains forward-looking statements. Any statements that are
not solely statements of historical fact are forward-looking statements. Words
such as "believe," "anticipate," "plan," "expect," "will," "may," "intend,"
"prepare," "look," "potential," "possible" and similar expressions are intended
to identify forward-looking statements. These forward-looking statements include
statements relating to our belief that belrestotug + dostarlimab are poised to
potentially advance the therapeutic regimen in the first-line PD-L1 high non-
small cell lung cancer setting and establish new benchmarks; and our belief that
initiating the Phase 3 program with this patient population will serve as the
foundation to our broader strategy and building a franchise.
These forward-looking statements involve risks and uncertainties, many of which
are beyond iTeos' control. Actual results could materially differ from those
stated or implied by these forward-looking statements as a result of such risks
and uncertainties. Known risk factors include the following: success in early
clinical trials does not ensure that later clinical trials will be successful,
and early results from a clinical trial do not necessarily predict final
results; interim and early data may change as more patient data become available
and are subject to audit and verification procedures; the expected benefits and
opportunities related to the agreement between iTeos and GSK may not be realized
or may take longer to realize due to a variety of reasons, including challenges
and uncertainties inherent in product research and development and manufacturing
limitations; and those risks identified under the heading "Risk Factors" in
iTeos' Quarterly Report on Form 10-Q for the period ended March 31, 2024 filed
with the Securities and Exchange Commission (SEC) as well as other SEC filings
made by the Company which you are encouraged to review.
Any of the foregoing risks could materially and adversely affect iTeos'
business, results of operations and the trading price of iTeos' common stock. We
caution investors not to place undue reliance on the forward-looking statements
contained in this press release. iTeos does not undertake any obligation to
publicly update its forward-looking statements other than as required by law.
For further information, please contact:
Investor Contact:
Carl Mauch
iTeos Therapeutics, Inc.
carl.mauch@iteostherapeutics.com (mailto:carl.mauch@iteostherapeutics.com)
Media Contact:
media@iteostherapeutics.com (mailto:media@iteostherapeutics.com)
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