– Data Support the Ongoing Phase 3 STAR-221
Study of Domvanalimab Plus Zimberelimab and Chemotherapy,
Potentially the First Anti-TIGIT Combination to Market for These
Cancers –
– 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 longer-term efficacy and safety
results from Arm A1 of the Phase 2 EDGE-Gastric study. These
updated data show consistent objective response rate (ORR) and
provide mature progression-free survival (PFS) in patients with
locally advanced unresectable or metastatic gastric,
gastroesophageal junction or esophageal adenocarcinoma (upper GI
cancers). The ongoing, multi-arm, global Phase 2 EDGE-Gastric study
is evaluating the safety and efficacy of various combinations of
the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1
monoclonal antibody zimberelimab and chemotherapy in this patient
population. These results will be presented today during the
American Society of Clinical Oncology (ASCO) Plenary Series: Rapid
Abstract Updates session by Yelena Y. Janjigian, M.D., Chief,
Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center,
and a principal investigator for the EDGE-Gastric study (Abstract
433248).
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240531335673/en/
“I am encouraged to see that patients treated with domvanalimab
plus zimberelimab and chemotherapy had a median progression-free
survival beyond one year, which exceeds the historical benchmarks
for anti-PD-1 plus chemotherapy alone,” said Dr. Janjigian.
“Notably, nearly 60% of patients in the EDGE-Gastric study achieved
progression-free survival at 12 months. These promising results
reinforce our confidence in the ongoing Phase 3 STAR-221 study,
which evaluates the same regimen in the same patient population and
has the potential to address a high unmet need for people with
these cancers.”
At data cutoff (DCO, March 12, 2024), safety and efficacy were
evaluated in all patients enrolled and treated (n=41). With a
median time on treatment of 49.4 weeks (range: 0.4 - 79.4 weeks),
the domvanalimab plus zimberelimab and chemotherapy regimen
demonstrated sustained improvement across efficacy measures,
including in those patients who have low PD-L1 expression.
Summary of efficacy results:
Endpoint
Overall*
PD-L1-high
PD-L1-low
n=41
(TAP ≥5%)
(TAP <5%)
n=16
n=24
Progression-Free Survival (PFS)
Median in Months (95% CI)
12.9 mos (9.8, 13.8)
13.8 mos (11.3, NE)
11.3 mos (5.5, 13.8)
12-month PFS Rate (95% CI)
57.6% (41.7,73.5)
68.8% (46.0, 91.5)
46.8% (24.7, 68.9)
Objective Response Rate
(ORR)
per RECIST v1.1
Confirmed ORR (95% CI)
58.5% (42.1, 73.7)
68.8% (41.3, 89.0)
50.0% (29.1, 70.9)
Complete Response
3 (7.3%)
1 (6.3%)
1 (4.2%)
Partial Response
21 (51.2%)
10 (62.5%)
11 (45.8%)
Stable Disease
14 (34.1%)
5 (31.3%)
9 (37.5%)
Progressive Disease Confirmed
2 (4.9%)
0
2 (8.3%)
Not Evaluable**
1 (2.4%)
0
1 (4.2%)
Median Duration of Response
(DOR) in Months
12.4 mos (9.9, NE)
NE (11.5, NE)
10.2 mos (4.0, 12.4)
*One subject with no tissue available for
central PD-L1 testing. From local lab results, the subject is PD-L1
low via 22-C3 assay. This subject achieved confirmed complete
response.
** One subject has no post baseline
scans.
CI: confidence interval
NE: not evaluable
TAP: tumor area positivity
No unexpected safety signals were observed at the time of DCO.
The domvanalimab plus zimberelimab and chemotherapy regimen was
generally well tolerated and showed an overall safety profile
consistent with the known safety profiles of each individual
molecule to date. Infusion-related reactions were observed in 19.5%
of the total subjects, and the majority were related to
chemotherapy.
The updated data from Arm A1 of the Phase 2 EDGE-Gastric study
support the ongoing Phase 3 STAR-221 study, in unresectable or
metastatic upper GI cancers, which is expected to complete
enrollment mid-year 2024.
Domvanalimab 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 gastrointestinal cancers have not
been established.
About the EDGE-Gastric
Study
The ongoing, multi-arm, multi-cohort global Phase 2 EDGE-Gastric
trial (NCT05329766) is evaluating the safety and efficacy of
various combinations of the Fc-silent anti-TIGIT antibody
domvanalimab and the anti-PD-1 monoclonal antibody zimberelimab in
patients with locally advanced unresectable or metastatic gastric
(G), gastroesophageal junction (GEJ) or esophageal (E)
adenocarcinoma. Patients in Arm A1, with previously untreated
G/GEJ/E adenocarcinoma, received 1600 mg of domvanalimab
intravenously (IV) every four weeks (Q4W) plus 480 mg of
zimberelimab IV Q4W + FOLFOX (oxaliplatin 85 mg/m2 IV, leucovorin
400 mg/m2 IV, fluorouracil 400 mg/m2 IV bolus + 2400 mg/m2
continuous 46-48-hour IV infusion) every two weeks.
About Domvanalimab
Domvanalimab is the first and most clinically advanced Fc-silent
investigational monoclonal antibody that is specifically designed
with Fc-silent properties to block and bind to the T-cell
immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint
receptor on immune cells that acts as a brake on the anticancer
immune response. By binding to TIGIT with Fc-silent properties,
domvanalimab is believed to work by freeing up immune-activating
pathways and activate immune cells to attack and kill cancer cells
without depleting the peripheral regulatory T cells important in
avoiding immune-related toxicity.
Combined inhibition of both TIGIT and programmed cell death
protein-1 (PD-1) is believed to significantly enhance immune cell
activation, as these checkpoint receptors play distinct,
complementary roles in anti-tumor activity. Domvanalimab is being
evaluated in combination with anti-PD-1 monoclonal antibodies,
including zimberelimab, as well as other investigational cancer
immunotherapies and A2a/A2b adenosine receptor antagonist
etrumadenant, in multiple ongoing and planned early and late-stage
clinical studies in various tumor types.
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.
Janjigian’s quote and statements regarding: whether data and
results from the EDGE-Gastric study reinforces our confidence in
our Phase 3 STAR-221 study and the potential of this regimen to
address a high unmet need for people with upper GI cancers; the
potential for domvanalimab in combination with zimberelimab and
chemotherapy to be first anti-TIGIT combination to market for upper
GI cancers; and the timing of upcoming milestones. 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 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, including domvanalimab and zimberelimab;
risks associated with the manufacturing or supplying product for
such clinical trials; uncertainties in timelines associated with
the conduct of clinical studies and with respect to the regulatory
application process; 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 domvanalimab
and zimberelimab (such as the EDGE-Gastric and STAR-221 studies);
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 domvanalimab 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).
_________________________________
Dr. Janjigian has served as a consultant to Arcus Biosciences;
she has not been paid for any media work.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240531335673/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
Arcus Biosciences (NYSE:RCUS)
Gráfica de Acción Histórica
De Nov 2024 a Dic 2024
Arcus Biosciences (NYSE:RCUS)
Gráfica de Acción Histórica
De Dic 2023 a Dic 2024
