– In Cohort B of the ARC-9 mCRC Study,
Etrumadenant Plus Zimberelimab, FOLFOX Chemotherapy and Bevacizumab
Significantly Reduced the Risk of Death by 63% and Risk of Disease
Progression by 73% Compared to Regorafenib in a Phase 1b/2 Trial
–
– Results will be Presented Today During an
Oral Session at the ASCO Annual Meeting –
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc.
(NYSE: RCUS) today announced new data from Cohort B of ARC-9, a
Phase 1b/2 study evaluating the safety and efficacy of
etrumadenant, a dual A2a/b adenosine receptor antagonist, plus
anti-PD-1 monoclonal antibody zimberelimab, FOLFOX chemotherapy and
bevacizumab (EZFB) in third-line metastatic colorectal cancer
(mCRC). These results will be presented today during an oral
session at the 2024 American Society of Clinical Oncology (ASCO)
Annual Meeting by Zev A. Wainberg, M.D., MSc, Co-Director of the GI
Oncology Program at University of California Los Angeles and a
principal investigator of the ARC-9 trial (Abstract 3508).
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“ARC-9 is the first randomized Phase 2 study to show that
combining an adenosine receptor blocker with anti-PD-1, anti-VEGF
and chemotherapy can meaningfully improve clinical outcomes for
people with metastatic colorectal cancer who have progressed on at
least two prior therapies,” said Dr. Wainberg. “19.7 months is the
longest median overall survival reported in third-line mCRC and
warrants further investigation of an etrumadenant-based regimen as
a potential treatment option in CRC1.”
Cohort B of ARC-9 randomized 112 patients with comparable
baseline characteristics between two arms: EZFB or regorafenib. At
the time of data cut-off (November 13, 2023) median follow-up was
20.4 months. Patient baseline characteristics were similar to those
of third-line patients who have progressed on oxaliplatin- and
irinotecan-based regimens in mCRC1. OS and PFS were consistently
longer in the EZFB arm versus regorafenib, in all sub-groups
analyzed, including in patients with liver metastases.
Summary of efficacy results:
EZFB*
n=75
regorafenib
n=37
Median OS, months
19.7
9.5
Hazard Ratio (95% CI),
P-value
HR 0.37
95% CI 0.22-0.63
p=0.0003
Median PFS, months
6.2
2.1
Hazard Ratio (95% CI),
P-value
HR 0.27
95% CI 0.17-0.43
p<0.0001
Confirmed ORR
13 (17.3%)
1 (2.7%)
Median DOR, months
11.5
NE
CI: confidence interval
OS: overall survival
PFS: progression-free survival
ORR: objective response rate
DOR: duration of response
NE: not evaluable; only one patient with
response
*bevacizumab was included for all patients
in whom it is not contraindicated
The EZFB regimen had a safety profile consistent with the known
safety profiles of each individual molecule to date, without
unexpected toxicities. A higher percentage of patients treated with
regorafenib (17%) had a treatment emergent adverse event (TEAE)
leading to discontinuation of all study drugs than those treated
with EZFB (5%). A lower percentage of patients experienced Grade ≥3
TEAEs attributed to etrumadenant or zimberelimab versus regorafenib
(23.0% vs 25.7%).
Etrumadenant and zimberelimab are investigational molecules.
Neither Gilead nor Arcus has received approval from any regulatory
authority for any use of these molecules, and their safety and
efficacy for the treatment of colorectal cancer have not been
established.
About the ARC-9 Study
ARC-9 (NCT04660812) is a Phase 1b/2 trial evaluating the safety
and efficacy of etrumadenant (E), a dual A2a/A2b adenosine receptor
antagonist, plus anti-PD-1 antibody zimberelimab (Z), FOLFOX and
bevacizumab (if not contraindicated) in three cohorts of patients
with mCRC. The primary endpoint is PFS per RECIST 1.1, and OS is a
key secondary endpoint. Cohort B enrolled patients who previously
progressed on both oxaliplatin- and irinotecan-containing
chemotherapy in combination with anti-VEGF (R) therapy or
anti-EGFR. Patients were randomized 2:1 to the etrumadenant plus
zimberelimab regimen: E (150 mg orally [PO] once daily [QD]) + Z
(240 mg intravenous [IV] once every 2 weeks [Q2W]) + mFOLFOX-6 +
bevacizumab (5 mg/kg IV Q2W), or regorafenib (administered at a
starting dose of 80 mg/day for the first week, followed by a dose
escalation of 40 mg every week to 120 mg/day for the second week
and 160 mg/day for the third week during Cycle 1 followed by 160
mg/day on Days 1-21 of each subsequent 28-day cycle). Patients who
progressed on regorafenib were allowed to crossover to the
etrumadenant plus zimberelimab regimen.
ARC-9 is a multi-cohort study in mCRC including Cohort A, which
enrolled patients who previously progressed on FOLFOX/FOLFIRI in
combination with anti-VEGF(R) or anti-EGFR. Patients were
randomized 2:1 to the etrumadenant plus zimberelimab regimen, or
FOLFOX-6 + bevacizumab. Data from Cohort A will be presented when
they are mature.
About Etrumadenant
Etrumadenant is an investigational small molecule, selective
dual antagonist of the A2a and A2b receptors designed to prevent
adenosine-mediated immunosuppression. Adenosine elicits its
immunosuppressive effects within the tumor microenvironment by
binding and activating adenosine-specific receptors expressed on
the surface of tumor-infiltrating immune cells, which can help
cancer cells evade host antitumor immunity. Once etrumadenant binds
to the A2a and A2b receptors and blocks the immunosuppressive
effects of adenosine, activation of antitumor immune cells may be
restored, which could result in tumor cell death.
Etrumadenant is being evaluated in combination with other cancer
immunotherapies, including the investigational Fc-silent anti-TIGIT
monoclonal antibody domvanalimab and anti-PD-1 monoclonal antibody
zimberelimab, in certain types of non-small cell lung and
colorectal cancers.
About Zimberelimab
Zimberelimab is an anti-programmed cell death protein-1 (PD-1)
monoclonal antibody that binds PD-1, with the goal of restoring the
antitumor activity of T cells. Zimberelimab has demonstrated high
affinity, selectivity and potency in various tumor types.
Zimberelimab is being evaluated in the U.S. and globally as a
foundational anti-PD-1 treatment option in multiple ongoing and
planned early and late-stage clinical studies in combination with
other immunotherapies, including investigational Fc-silent
anti-TIGIT monoclonal antibody domvanalimab and A2a/A2b adenosine
receptor antagonist etrumadenant.
Guangzhou Gloria Biosciences Co. Ltd., which holds
commercialization rights for zimberelimab in greater China, has
obtained approval for zimberelimab for the treatment of recurrent
or metastatic cervical cancer and for relapsed or refractory
classical Hodgkin's lymphoma. Zimberelimab is not approved for any
use in the U.S. or other regions outside of China. Gloria conducts
its development and commercialization activities independent of
Arcus and Gilead.
About Arcus Biosciences
Arcus Biosciences is a clinical-stage, global biopharmaceutical
company developing differentiated molecules and combination
medicines for people with cancer. In partnership with industry
collaborators, patients and physicians around the world, Arcus is
expediting the development of first- or best-in-class medicines
against well-characterized biological targets and pathways and
studying novel, biology-driven combinations that have the potential
to help people with cancer live longer. Founded in 2015, the
company has expedited the development of multiple investigational
medicines into clinical studies, including new combination
approaches that target TIGIT, PD-1, the adenosine axis (CD73 and
dual A2a/A2b receptor), HIF-2a, CD39 and AXL. For more information
about Arcus Biosciences’ clinical and preclinical programs, please
visit www.arcusbio.com.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis, COVID-19, and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City,
California.
Arcus Forward-Looking
Statements
This press release contains forward-looking statements. All
statements regarding events or results to occur in the future
contained herein are forward-looking statements reflecting the
current beliefs and expectations of management made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including, but not limited to, the statements in Dr.
Wainberg quote and statements regarding: whether data and results
from the ARC-9 study validate our pipeline or support further
development of etrumadenant and/or zimberelimab. All
forward-looking statements involve known and unknown risks and
uncertainties and other important factors that may cause Arcus’s
actual results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements.
Factors that could cause or contribute to such differences include,
but are not limited to risks associated with: interim data changing
as patient enrollment continues and more patient data becomes
available; interim data not being replicated in future studies
evaluating the same investigational molecules or regimen; the
unexpected emergence of adverse events or other undesirable side
effects in Arcus’s investigational products; Arcus’s dependence on
the collaboration with Gilead for the successful development and
commercialization of its optioned molecules; difficulties
associated with the management of the collaboration activities with
our strategic partners or expanded clinical programs; changes in
the competitive landscape for Arcus’s programs; and the inherent
uncertainty associated with pharmaceutical product development and
clinical trials. Risks and uncertainties facing Arcus are described
more fully in the “Risk Factors” section of Arcus’s most recent
periodic report filed with the U.S. Securities and Exchange
Commission. You are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this
press release. Arcus disclaims any obligation or undertaking to
update, supplement or revise any forward-looking statements
contained in this press release except to the extent required by
law.
Gilead Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including Gilead’s ability to initiate, progress or complete
clinical trials within currently anticipated timelines or at all,
and the possibility of unfavorable results from ongoing or
additional clinical trials, including those involving etrumadenant
and zimberelimab (such as the ARC-9 study); uncertainties relating
to regulatory applications and related filing and approval
timelines, and the risk that any such approvals, if granted, may be
subject to significant limitations on use; the possibility that
Gilead may make a strategic decision to discontinue development of
etrumadenant and zimberelimab for indications that are currently
under evaluation and, as a result, these programs may never be
successfully commercialized for such indications; the risk that
Gilead may not realize the potential benefits of its collaboration
with Arcus or its other investments in oncology; difficulties or
unanticipated expenses in connection with the collaboration and the
potential effects on Gilead’s revenues and earnings; and any
assumptions underlying any of the foregoing. These and other risks,
uncertainties and other factors are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2024,
as filed with the U.S. Securities and Exchange Commission. These
risks, uncertainties and other factors could cause actual results
to differ materially from those referred to in the forward-looking
statements. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements. The
reader is cautioned that any such forward-looking statements are
not guarantees of future performance and involve risks and
uncertainties, and is cautioned not to place undue reliance on
these forward-looking statements. All forward-looking statements
are based on information currently available to Gilead, and Gilead
assumes no obligation and disclaims any intent to update any such
forward-looking statements.
Gilead and the Gilead logo are trademarks of
Gilead Sciences, Inc., or its related companies. Arcus name and
logo are trademarks of Arcus Biosciences, Inc.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X/Twitter
(@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
___________________________________
1 Prager GW, et al. Trifluridine-Tipiracil and Bevacizumab in
Refractory Metastatic Colorectal Cancer. N Engl J Med.
2023;388(18):1657-1667. doi: 10.1056/NEJMoa2214963. PMID:
37133585.
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version on businesswire.com: https://www.businesswire.com/news/home/20240531380992/en/
Meaghan Smith, Gilead Media public_affairs@gilead.com
Jacquie Ross, Gilead Investors investor_relations@gilead.com
Pia Eaves, Arcus Investors peaves@arcusbio.com, (617)
459-2006
Holli Kolkey, Arcus Media hkolkey@arcusbio.com, (650)
922-1269
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