– Fourth Interim Analysis Shows Continued
Clinically Meaningful Differentiation Across All Efficacy Measures,
Including PFS, in Both Domvanalimab-Containing Arms Compared to the
Anti-PD-1 Zimberelimab Monotherapy Arm in First-Line NSCLC Patients
–
– Data will be Presented on December 20,
2022 at the American Society of Clinical Oncology (ASCO) Monthly
Plenary Series –
– Three Phase 3 Domvanalimab Combination
Studies in NSCLC are Ongoing –
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences
(NYSE: RCUS) today announced a positive update from the fourth
interim analysis of the randomized, open-label Phase 2 ARC-7 study
in patients with first-line metastatic non-small cell lung cancer
(NSCLC) with PD-L1 tumor proportion score (TPS) ≥50% without
epidermal growth factor receptor or anaplastic lymphoma kinase
(EGFR/ALK) mutations. ARC-7 is evaluating the combinations of
anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody
zimberelimab (doublet), and domvanalimab plus zimberelimab and
etrumadenant, an A2a/b adenosine receptor antagonist (triplet),
versus zimberelimab alone, and represents the first randomized
Phase 2 study of an Fc-silent anti-TIGIT/anti-PD-1 combination. The
protocol-specified fourth interim analysis was conducted when the
trial reached full enrollment, with a clinical data cutoff date of
August 31, 2022. A total of 150 patients have been randomized
across the three study arms.
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For the current interim analysis, efficacy was evaluated in
study patients who had at least 13 weeks of potential follow-up and
were eligible for at least two imaging scans (n=133). Both
domvanalimab combinations continued to show clinically meaningful
differentiation compared to zimberelimab monotherapy across
multiple efficacy measures, including objective response rates
(ORR), progression-free survival (PFS) and six-month landmark
PFS.
“The efficacy measures observed, including PFS, reinforce
confidence in the TIGIT pathway. The interim results show that
combining two checkpoint inhibitors – an anti-TIGIT and an
anti-PD-1 – delivered added benefit beyond anti-PD-1
monotherapy in this setting,” said Melissa L. Johnson, M.D.,
Director Lung Cancer Research, Sarah Cannon Research Institute at
Tennessee Oncology, and Lead Investigator for the ARC-7 study.
“These data are important for the lung cancer research field, and I
look forward to presenting the dataset at the upcoming virtual ASCO
Monthly Plenary on December 20th.”
At time of data cutoff, no unexpected safety signals were
observed across the three study arms. Both domvanalimab-containing
arms were generally well tolerated and showed an overall safety
profile consistent with the known safety profiles for each
individual molecule to date.
“We are thrilled that Dr. Melissa Johnson will present the full
results for the current interim analysis of ARC-7, including ORR,
PFS and disease control rate, in the coming weeks, given the
importance of these data for the immuno-oncology field,” said
Dimitry S.A. Nuyten, M.D., Ph.D., Chief Medical Officer of Arcus
Biosciences. “The consistency of the efficacy and safety data from
both of the domvanalimab-containing arms observed at this interim
analysis support our continued strong conviction in the
domvanalimab program.”
“These results strengthen our belief in the potential of
domvanalimab and the promise of our anti-TIGIT approach to
meaningfully impact the outlook for people with metastatic lung
cancer,” said Bill Grossman, M.D., Ph.D., Senior Vice President,
Therapeutic Area Head, Gilead Oncology. “We will continue to
accelerate our TIGIT development program with Arcus, with four
ongoing registrational studies in NSCLC and upper GI
malignancies.”
Detailed results from this fourth interim analysis and an
exploratory analysis on 12 patients who crossed over from
zimberelimab monotherapy arm to triplet therapy will be presented
on December 20, 2022, at the Monthly Plenary Series, a new virtual
forum for presentation and discussion of the latest cancer
research. According to ASCO, live presentations are accessible to
virtual attendees and available on-demand, and abstract
presentations are accompanied by a discussant presentation and
followed by a live Q&A session. Abstracts accepted for the
Monthly Plenary Session are also placed at the ASCO Annual Meeting
in June 2023. During the ASCO Annual Meeting, additional results
from further analysis of the ARC-7 dataset will be presented.
Domvanalimab, zimberelimab and etrumadenant are investigational
molecules and neither Arcus or Gilead have received approval from
any regulatory authority for any use globally, including for the
treatment of lung cancer. Their efficacy and safety for the
treatment of lung cancer have not been established.
About the ARC-7 Study
The ARC-7 study is a Phase 2, multicenter, 3-arm, randomized
open-label study evaluating the safety and efficacy of anti-TIGIT
antibody domvanalimab plus anti-PD-1 antibody zimberelimab
(doublet) versus domvanalimab plus zimberelimab and etrumadenant
(triplet), an A2a/b adenosine receptor antagonist, versus
zimberelimab alone in 150 patients with first-line metastatic
non-small cell lung cancer with PD-L1 TPS ≥50% and no EGFR or ALK
mutations. Patients are randomized 1:1:1 across the three study
arms, and patients who progress on zimberelimab monotherapy may
cross over to receive the triplet. At the time of the fourth
interim analysis, 133 patients had at least 13 weeks of potential
follow-up (eligible for at least two tumor assessments). The
co-primary endpoints are objective response rate and
progression-free survival per Response Evaluation Criteria in Solid
Tumors (RECIST 1.1). Secondary endpoints include duration of
response, disease control rate, overall survival and safety. More
information about ARC-7 is available at
https://clinicaltrials.gov/ct2/show/NCT04262856.
About Domvanalimab
Domvanalimab is an Fc-silent investigational monoclonal antibody
that is designed to bind to 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 targeted
cells. 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 six 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 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, including, but not limited to, statements
regarding future data disclosures and presentations, the
development of current and future programs, and the efficacy and
the safety of domvanalimab, zimberelimab or etrumadenant 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.
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, zimberelimab and
etrumadenant; 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 its
quarterly report on Form 10-Q for the quarter ended September 30,
2022, filed on November 2, 2022, with the SEC. 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,
etrumadenant 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
candidates and as a result, domvanalimab, etrumadenant 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 September 30,
2022, 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.
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 Twitter
(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20221127005111/en/
Gilead Contacts: Jacquie Ross, Investors
investor_relations@gilead.com
Meaghan Smith, Global Media public_affairs@gilead.com
Arcus Contacts: Pia Banerjee, Investors
pbanerjee@arcusbio.com, (617) 459-2006
Holli Kolkey, Media hkolkey@arcusbio.com, (650) 922-1269
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