– Preliminary data from Arm A1 of the
Phase 2 EDGE-Gastric study showed promising ORR and six-month PFS
results, irrespective of PD-L1 expression –
– Domvanalimab is the only Fc-silent
anti-TIGIT antibody in Phase 3 for upper GI adenocarcinomas and has
the potential to be first to market for these cancers –
– Detailed results will be presented on
November 7 at 12pm PT / 3pm ET during the ASCO Monthly Plenary
Series –
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc.
(NYSE: RCUS) today announced that domvanalimab plus zimberelimab
and chemotherapy showed encouraging overall response rate (ORR) and
six-month progression-free survival (PFS) rate results in a
preliminary analysis from Arm A1 of the EDGE-Gastric study. This
ongoing Phase 2, multi-arm, global study is evaluating the safety
and efficacy of various combinations of the Fc-silent anti-TIGIT
antibody domvanalimab plus the anti-PD-1 antibody zimberelimab and
chemotherapy in patients with locally advanced unresectable or
metastatic gastric, gastroesophageal junction or esophageal
adenocarcinoma. These results will be presented tomorrow during the
American Society of Clinical Oncology (ASCO) Monthly Plenary
Series, a virtual forum for presentation and discussion of the
latest cancer research.
“The preliminary data from the EDGE-Gastric study underscore the
potential role of dual anti-TIGIT and anti-PD-1-containing regimen
in the treatment of gastroesophageal cancer where front-line
chemotherapy with anti-PD-1 blockade is currently the standard,”
said Yelena Y. Janjigian, M.D., Chief Attending Physician of the
Gastrointestinal Medical Oncology Service, Memorial Sloan Kettering
Cancer Center, and a principal investigator for the EDGE-Gastric
study. “These early data are encouraging and indicate the potential
for the anti-TIGIT, domvanalimab-based therapy to improve upon
anti-PD-1 and chemotherapy in this setting, with a similar safety
profile to anti-PD-1 and chemotherapy.”
At data cutoff (September 4, 2023), 41 patients were enrolled
and treated with a median follow-up of 8.1 months; 24 patients
(59%) remained on study treatment at time of data cutoff. Median
time on treatment was 33 weeks (range: <1 to 53 weeks).
The domvanalimab-containing regimen showed an objective response
rate (ORR) of 80% in patients with PD-L1-high tumors (tumor
activity positivity (TAP) ≥5%), 46% in patients with PD-L1-low
tumors (TAP <5%) and 59% for patients overall. There were two
confirmed complete responses. Six-month landmark PFS rate was 93%
for patients with PD-L1-high tumors (TAP ≥5%), 68% for patients
with PD-L1-low tumors (TAP <5%) and 77% for patients overall.
Median PFS was not reached and mature PFS data are expected in the
second half of next year.
The efficacy results including ORR and six-month PFS rates are
summarized in the table below:
PD-L1-high*
(TAP ≥5%)
N=15
n (%)
PD-L1-low* (TAP <5%)
N=24
n (%)
Overall
N=41
n (%)
ORR (95% CI)
80%
(52,96)
46%
(26,67)
59%
(42,74)
Confirmed ORR (95% CI)
73%
(45,92)
46%
(26,67)
56%
(40,72)
6-month PFS Rate (95% CI)
93%
(81,100)
68%
(48,88)
77%
(64,90)
*Tumor samples from 2 patients were not available for central
PD-L1 testing
CI: confidence interval
The domvanalimab-containing regimen was well tolerated, with a
similar safety profile to what has been reported for anti-PD-1 plus
chemotherapy in this setting. The most common adverse events (AEs)
were neutropenia (59%), nausea (54%), anemia (27%) and fatigue
(27%). Infusion-related reactions were observed in 20% and the
majority (17%) were related to chemotherapy. No patients
experienced serious immune-mediated AEs, and there were no
treatment-emergent adverse events (TEAEs) resulting in death.
These data add to the growing body of evidence that
domvanalimab, an Fc-silent anti-TIGIT antibody, has a
differentiated safety and tolerability profile relative to
published data from studies with Fc-enabled anti-TIGIT
antibodies.
The preliminary data from Arm A1 of the Phase 2 EDGE-Gastric
study support the ongoing Phase 3 study, STAR-221, in unresectable
or metastatic upper GI cancers. The companies have three additional
ongoing Phase 3 registrational studies of domvanalimab-containing
regimens in lung cancer, including STAR-121, ARC-10 and
PACIFIC-8.
Domvanalimab and zimberelimab are investigational molecules.
Neither Gilead nor Arcus has received approval from any regulatory
authority for any use globally, and their safety and efficacy for
the treatment of gastrointestinal and lung cancers have not been
established.
About the EDGE-Gastric
Study
The ongoing, multi-arm, global 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
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 Fc-silent investigational monoclonal
antibody in pivotal trials that is designed to block and bind to
the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a
protein receptor on immune cells that acts as a brake on the immune
response. Cancer cells can exploit TIGIT to avoid detection by the
immune system. By binding to TIGIT, domvanalimab is expected to
free up immune activating pathways and activate immune cells to
attack and kill cancer cells. Domvanalimab has demonstrated
complete receptor coverage on all TIGIT-expressing peripheral
leukocytes.
Domvanalimab is being evaluated in four registrational Phase 3
studies across lung and gastrointestinal cancers, including: (1)
ARC-10, evaluating domvanalimab plus zimberelimab versus
pembrolizumab in first-line locally advanced or metastatic PD-L1
≥50% NSCLC; (2) PACIFIC-8, being operationalized by AstraZeneca,
evaluating domvanalimab plus durvalumab in unresectable Stage 3
NSCLC; (3) STAR-121, evaluating domvanalimab plus zimberelimab and
chemotherapy versus pembrolizumab plus chemotherapy in first-line
PD-L1-unselected NSCLC; and (4) STAR-221, evaluating domvanalimab
plus zimberelimab and chemotherapy versus nivolumab plus
chemotherapy in first-line locally advanced, unresectable or
metastatic gastric, esophageal and gastro-esophageal junction
adenocarcinomas.
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
partners, 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) and HIF-2a. For more information about Arcus
Biosciences’ clinical and pre-clinical 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.
Janjiagan’s quote and statements regarding: the safety and
tolerability of domvanalimab, projected timing of future results
and whether data and results from current studies support further
development of a program. All forward-looking statements involve
known and unknown risks and uncertainties and other important
factors that may cause our 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:
dependence on the collaboration with Gilead for the successful
development and commercialization of Arcus’s investigational
products, including domvanalimab and zimberelimab; difficulties
associated with the management of the collaboration activities or
expanded clinical programs; risks associated with preliminary and
interim data not being guarantees that future data will be similar;
the inherent uncertainty associated with pharmaceutical product
development and clinical trials; delays in Arcus’s clinical trials
due to difficulties or delays in the regulatory process, enrolling
subjects or manufacturing or supplying product for such clinical
trials; and changes in the competitive landscape for Arcus’s
programs. Risks and uncertainties facing Arcus are described more
fully in the “Risk Factors” section of Arcus’s most recent
Quarterly Report on Form 10-Q 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.
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/or zimberelimab; uncertainties relating to regulatory
applications for these and other candidates and related filing and
approval timelines; Gilead’s ability to receive regulatory
approvals for such indications in a timely manner or at all, and
the risk that any such approvals may be subject to significant
limitations on use; the possibility that Gilead may make a
strategic decision to discontinue development of these programs and
as a result, domvanalimab and/or zimberelimab may never be
commercialized; 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 June 30, 2023, 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.
Dr. Janjigian provides consulting services to
Arcus Biosciences.
The Arcus name and logo are trademarks of Arcus
Biosciences, Inc., and Gilead and the Gilead logo are trademarks of
Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X
(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231106343567/en/
Gilead Contacts:
Jacquie Ross, Investors investor_relations@gilead.com
Meaghan Smith, Media public_affairs@gilead.com
Arcus Contacts:
Pia Eaves, Investors peaves@arcusbio.com, (617) 459-2006
Holli Kolkey, Media hkolkey@arcusbio.com, (650) 922-1269
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