– Clinically Meaningful Reduction in Risk of
Progression or Death Was Observed in the Domvanalimab-Containing
Study Arms Compared to Zimberelimab Monotherapy in First-Line,
PD-L1-High NSCLC –
– Objective Response Rate (ORR) Improved in
Both Domvanalimab-Containing Study Arms Compared to Zimberelimab
Monotherapy –
– Results Will Be Presented Today During the
American Society of Clinical Oncology Annual Meeting –
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc.
(NYSE: RCUS) today announced updated results from an interim
analysis of the 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 (EGFR) or
anaplastic lymphoma kinase (ALK) mutations. ARC-7 is the first
Phase 2, randomized, open-label study evaluating the combinations
of Fc-silent anti-TIGIT monoclonal antibody domvanalimab plus
anti-PD-1 monoclonal antibody zimberelimab (doublet) and
domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine
receptor antagonist (triplet), versus zimberelimab monotherapy.
These results will be presented today during the American Society
of Clinical Oncology (ASCO) Plenary Series: Rapid Abstract Updates
session by Melissa L. Johnson, M.D., Director, Lung Cancer
Research, Sarah Cannon Research Institute, and Lead Investigator
for the ARC-7 study.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20230602005426/en/
“Progression-free survival curves showed early separation of
both domvanalimab-containing arms from the zimberelimab arm, which
was consistently maintained, and supports the potential therapeutic
benefit of inhibiting the TIGIT pathway,” said Melissa L. Johnson,
M.D., Director, Lung Cancer Research, Sarah Cannon Research
Institute, and Lead Investigator for the ARC-7 study. “I was also
encouraged by the consistency of meaningful improvements across
other outcome measures for the domvanalimab-containing arms. I look
forward to continuing to work with Gilead and Arcus on the dom-zim
combinations.”
At the time of data cutoff (DCO), February 7, 2023, safety and
efficacy were evaluated in all patients randomized and treated
(n=150). With a median follow-up time of approximately 18 months,
both domvanalimab-containing study arms demonstrated sustained,
clinically meaningful improvements in progression-free survival
(PFS) compared to zimberelimab monotherapy, with a 33% reduction in
risk of disease progression or death for the doublet and 28% for
the triplet.
The efficacy data, including PFS and ORR, are summarized in the
table below:
Endpoint
zimberelimab (Z) monotherapy
(n=50)
domvanalimab + zimberelimab (DZ)
(n=50)
etrumadenant + domvanalimab +
zimberelimab (EDZ) (n=50)
Progression-Free Survival (PFS)
Median in Months (95% CI)
5.4 (2.7, 9.7)
9.3 (4.1, NE)
9.9 (4.8, 14.6)
Hazard Ratio* (95% CI)
0.67 (0.4, 1.13)
0.72 (0.63, 1.8)
Six-month PFS rate (95% CI)
45% (30, 59)
58% (43, 72)
62% (48, 76)
12-month PFS rate (95% CI)
25% (11, 40)
41% (26, 56)
44% (29, 59)
Objective Response Rate (ORR)
ORR+ Confirmed + Pending (95%
CI)
15 (30%)
[17.9%, 44.6%]
20 (40%)++
[26.4%, 54.8%]
22 (44%)
[30%, 58.7%]
Complete Response
1 (2%)
1 (2%)
0 (0%)
Partial Response Confirmed
14 (28%)
18 (36%)
22 (44%)
Partial Response Pending
0 (0%)
1 (2%)
0 (0%)
Stable Disease
16 (32%)
18 (36%)
16 (32%)
Progressive Disease
12 (24%)
4 (8%)
7 (14%)
Not Evaluable (NE)
7 (14%)
8 (16%)
5 (10%)
CI=Confidence Interval
*
Comparing DZ and EDZ arms to Z
monotherapy.
+
Per RECIST 1.1
++
Across all arms, one participant
in the DZ arm had a response pending confirmation, which was
confirmed after DCO date.
-
Preliminary duration of response
(DoR) analyses favor domvanalimab-containing arms, with median DoR
(range, ‘+’: censored) as follows: Z: 13.2mo (+1.4-+19.4), DZ: not
reached (2.8-+26.6), EDZ: 23.7mo (2.6-23.7).
-
As of the DCO, approximately
twice as many participants remain on study treatment in the
domvanalimab-containing arms compared to zimberelimab monotherapy
[Z: (n=9), DZ: (n=17), EDZ: (n=20)].
-
Consistent ORR and PFS
improvements were shown for the domvanalimab-containing arms in a
post-hoc analysis of centrally confirmed PD-L1-high patients.
“At this analysis, the domvanalimab-containing study arms
continued to show improved efficacy across multiple measures and
both the doublet and triplet arms were generally well tolerated,”
said Dimitry S.A. Nuyten, M.D., Ph.D., Chief Medical Officer of
Arcus Biosciences. “These data reinforce our confidence in the
domvanalimab program.”
“The ARC-7 proof-of-concept study has critically advanced our
understanding of the activity of domvanalimab, the first Fc-silent
anti-TIGIT monoclonal antibody in pivotal trials,” said Bill
Grossman, M.D., Ph.D., Senior Vice President, Therapeutic Area
Head, Gilead Oncology. “We look forward to quickly advancing our
four ongoing Phase 3 registrational programs in NSCLC and upper GI
cancers.”
No unexpected safety signals were observed across the three
study arms at the time of DCO. The domvanalimab-containing study
arms appeared to be generally well tolerated and showed an overall
safety profile consistent with the known safety profiles of each
individual molecule to date. Incidence of infusion-related
reactions was low across all treatment arms: 4%, 4% and 12% for
zimberelimab monotherapy and the domvanalimab-doublet and -triplet
arms, respectively. The addition of domvanalimab to zimberelimab
did not increase the incidence of infusion-related reactions,
consistent with the Fc-silent design of domvanalimab.
Domvanalimab, zimberelimab and etrumadenant 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 lung cancer have not been
established.
About the ARC-7 Study
The ARC-7 study is the first Phase 2, multicenter, three-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 monotherapy in 150 patients with first-line
metastatic non-small cell lung cancer (NSCLC) 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
this interim analysis, 150 patients had a median follow-up of 18.5
months. 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. ARC-7
is a proof-of-concept study to assess the safety and efficacy of
domvanalimab-containing study arms over zimberelimab monotherapy.
More information about ARC-7 is available at:
https://clinicaltrials.gov/ct2/show/NCT04262856.
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 advanced multiple investigational medicines into
clinical studies, including new combination approaches that target
TIGIT, PD-1, the adenosine axis (CD73 and A2a/A2b receptors) and
HIF-2a. 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 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 statements regarding:
future data disclosures and presentations, the development and
advancement of the TIGIT program, including the four ongoing Phase
3 studies, the therapeutic benefit, including the efficacy and the
safety, of Arcus’s product candidates. 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 March 31, 2023,
filed on May 9, 2023, 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; the possibility that Gilead may
make a strategic decision to discontinue development of these
product candidates for any indications that are currently under
investigation, and as a result, domvanalimab, etrumadenant and/or
zimberelimab may never be commercialized for such indications;
uncertainties relating to regulatory applications for these and
other candidates and related filing and approval timelines; the
risk that any regulatory approvals, if granted, may be subject to
significant limitations on use; 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, 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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230602005426/en/
Gilead Contacts: Jacquie Ross, Investors
investor_relations@gilead.com
Meaghan Smith, Media Public_affairs@gilead.com
Arcus Contact: Holli Kolkey, Investors and Media
hkolkey@arcusbio.com (650) 922-1269
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Apr 2024 to May 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From May 2023 to May 2024