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,
today announced follow-up interim data from GALAXIES Lung-201, the
Phase 2 platform study sponsored by iTeos’ development partner GSK,
assessing the belrestotug + dostarlimab doublet in previously
untreated, unresectable, locally advanced or metastatic PD-L1 high
non-small cell lung cancer (NSCLC).
“We are encouraged by this interim cut of
GALAXIES Lung-201 data in which a clinically meaningful,
investigator-assessed Objective Response Rate was observed with
belrestotug in combination with dostarlimab in first-line, PD-L1
high non-small cell lung cancer patients. Further, with roughly 60
percent confirmed ORR at three distinct doses and a meaningful
difference of 30 percent compared to dostarlimab alone, we believe
this underscores the potential differentiation of our TIGIT:PD-1
doublet,” said Michel Detheux, Ph.D., president and chief executive
officer of iTeos. “The improvement in depth of response in tumor
measurement in patients treated with the doublet compared to those
treated with PD-1 alone holds promising therapeutic potential for a
patient population with limited options. We believe these
encouraging data further support the recent initiation of GALAXIES
Lung-301, the registrational Phase 3 trial assessing the TIGIT:PD-1
doublet in the same indication and setting. Based on these results,
we are committed to leveraging our science to impact the lives of
people living with cancer and are excited to see longer-term
follow-up data in 2025.”
“While checkpoint inhibitor therapies have
played a significant role in how we treat non-small cell lung
cancer, the medical community continues to look for new
patient-centered treatment options to meaningfully improve this
life-threatening condition,” said Brian Henick, M.D., interim
director of experimental therapeutics and director of translational
research in upper-aerodigestive malignancies in medical oncology of
Columbia University Irving Medical Center. “The follow-up interim
analysis from the GALAXIES Lung-201 study represent promising
progress and the deep responses observed in the belrestotug +
dostarlimab doublet provide a strong, consistent signal. We eagerly
anticipate gaining further insights from this trial over the next
year as the dataset matures.”
Highlights of Interim GALAXIES Lung-201
DataAs of the June 7, 2024 data cutoff, the late-breaking
interim data presented at the ESMO Congress were based on 124
patients eligible for safety and efficacy evaluation (modified
intention-to-treat ≥5.6 months follow-up). Patients received
dostarlimab or belrestotug + dostarlimab at the following dose
levels: dostarlimab 500mg, belrestotug 100mg + dostarlimab 500mg
(Dose A), belrestotug 400mg + dostarlimab 500mg (Dose B), and
belrestotug 1000mg + dostarlimab 500mg (Dose C).
- Clinically meaningful improvement
in the primary endpoint of ORR was observed consistently across
each belrestotug + dostarlimab cohort (63.3% Dose A, 65.6% Dose B
and 76.7% Dose C compared to 37.5% with dostarlimab alone). cORR,
defined as complete or partial response confirmed by repeat imaging
≥4 weeks after response criteria first met, was roughly 60.0% for
each dose compared to 28.1% cORR for dostarlimab alone.
- Of the patients with evaluable
paired ctDNA samples (baseline and week 7), median ctDNA reduction
was 65% for dostarlimab monotherapy compared to 55% for Dose A, 94%
for Dose B, and 97% for Dose C.
- Belrestotug + dostarlimab led to an
increase in immune-related adverse events compared to dostarlimab
monotherapy, which were generally manageable. The safety profile of
belrestotug in combination with dostarlimab has been broadly
consistent with the known safety profile of combination therapy
with checkpoint inhibitors. The most frequent treatment-related
adverse events (≥15%) were skin and subcutaneous tissue disorders
(50%) and endocrine disorders (26%), both commonly observed with
immunotherapies.
Response measure in mITT |
Dostarlimab(N=32) |
Dose A:Dostarlimab
+belrestotug100
mg(N=30) |
Dose B:Dostarlimab
+belrestotug400
mg(N=32) |
Dose C:Dostarimab
+belrestotug1000
mg(N=30) |
Median follow-up, months (range) |
7.0 (0.2–16.6) |
8.5 (0.3–14.3) |
8.5 (0.4–16.2) |
6.7 (2.4–9.7) |
ORR,1,2%n
(95% CI) |
37.5%n=12 (21.1–56.3) |
63.3%n=19 (43.9–80.1) |
65.6%n=21 (46.8–81.4) |
76.7%n=23 (57.7–90.1) |
Complete response, n (%) |
0 |
0 |
0 |
0 |
Partial response, n (%) |
12 (37.5%) |
19 (63.3%) |
21 (65.6%) |
23 (76.7%) |
Stable disease, n (%) |
14 (43.8%) |
5 (16.7%) |
4 (12.5%) |
5 (16.7%) |
Progressive disease, n (%) |
2 (6.3%) |
4 (13.3%) |
3 (9.4%) |
2 (6.7%) |
Not evaluable/no assessment,3 n (%) |
4 (12.5%) |
2 (6.7%) |
4 (12.5%) |
0 |
Confirmed ORR,2
%n (95% CI) |
28.1% n=9 (13.7–46.7) |
60.0% n=18 (40.6–77.3) |
59.4% n=19 (40.6–76.3) |
63.3%n=19 (43.9–80.1) |
1. unconfirmed ORR; 2. PD-L1 high (TPS ≥50%) was
determined locally or centrally by DAKO 22C3 or VENTANA SP263
assay; 3. patients who only had "not evaluable" post baseline
assessments, those who had a best response of "not evaluable" per
RECIST 1.1 criteria, or those where no post-baseline tumor
assessment was performed; CI, confidence interval
Conference Call DetailsThe
follow-up interim data from GALAXIES Lung-201 will be discussed
during a conference call and webcast presentation on Monday,
September 16th, 2024 at 8:00AM ET. To register for the webcast
presentation, please visit the Events section on the Investors page
of the iTeos website at investors.iteostherapeutics.com. A webcast
replay may be accessed on the Investors section of the iTeos
website.
Phase 2 GALAXIES Lung-201 Trial
DesignThe Phase 2 GALAXIES Lung-201 study is a randomized,
open-label, global platform study evaluating the efficacy, safety,
pharmacokinetics, and pharmacodynamics of novel immunotherapy
combinations compared with immunotherapy monotherapy in
participants with PD-L1 high (TPS ≥50%), previously untreated,
unresectable, locally advanced or metastatic NSCLC. Arms and
interventions in this study include: pembrolizumab (anti-PD-1)
monotherapy, dostarlimab (anti-PD-1) monotherapy, belrestotug
(anti-TIGIT) + dostarlimab doublet combination, and belrestotug +
dostarlimab + nelistotug (anti-CD96) triplet combination.
The primary endpoint of the study is
investigator-assessed ORR per Response Evaluation Criteria in Solid
Tumors (RECIST 1.1). Secondary endpoints include safety and
additional efficacy measures such as progression free survival,
overall survival, and duration of response.
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 and adaptive 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 FcγR, 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.
Internet Posting of
InformationiTeos routinely posts information that may be
important to investors in the 'Investors' section of its website
at www.iteostherapeutics.com. The Company encourages investors
and potential investors to consult our website regularly for
important information about iTeos.
Forward-Looking StatementsThis
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 the potential benefits of
belrestotug and the potential differentiation of belrestotug +
dostarlimab; belrestotug’s market opportunity; and our plans and
expected milestones, including having longer-term follow-up data
from GALAXIES Lung-201 in 2025.
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
preclinical testing and 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 data for our
product candidates may not be sufficient for obtaining regulatory
approval to move into later stage trials or to commercialize
products; iTeos may not be able to execute on its business plans,
including meeting its expected or planned regulatory milestones and
timelines, research and clinical development plans, and bringing
its product candidates to market, for various reasons, some of
which may be outside of iTeos’ control, including possible
limitations of company financial and other resources, manufacturing
limitations that may not be anticipated or resolved for in a timely
manner, negative developments in the field of immuno-oncology, such
as adverse events or disappointing results, including in connection
with competitor therapies, and regulatory, court or agency
decisions such as decisions by the United States Patent and
Trademark Office with respect to patents that cover our product
candidates; and those risks identified under the heading “Risk
Factors” in iTeos’ Annual Report on Form 10-Q for the period ended
June 30, 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 MauchiTeos Therapeutics,
Inc.carl.mauch@iteostherapeutics.com
Media Contact:media@iteostherapeutics.com
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