- Objective response rate of 34% (2 responses pending
confirmation) and 25% (confirmed) in the 100mg daily dose expansion
cohort (n=32) of ARC-20, a Phase 1/1b study of casdatifan in
metastatic clear cell renal cell carcinoma (ccRCC)
- Low rate of primary progression (19%) and high rate of disease
control (81%) was observed in the 100mg expansion cohort with many
of those patients still on treatment
- Arcus will host a conference call to discuss these results,
including results from the 50mg expansion cohort, at 5:00 AM PT /
8:00 AM ET today
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global
biopharmaceutical company focused on developing differentiated
molecules and combination therapies for patients with cancer, today
presented the first clinical activity data for casdatifan, a HIF-2a
inhibitor with best-in-class potential, in an oral plenary session
by Dr. Toni K. Choueiri, Dana-Farber Cancer Institute at the 2024
EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Therapeutics in Barcelona, Spain.
“Based on our experience in the ARC-20 study, we have seen
casdatifan’s ability to quickly bring tumor growth under control
and its high response and disease control rates,” said Toni K.
Choueiri, M.D., director of the Lank Center for Genitourinary (GU)
Oncology at Dana-Farber, the Jerome and Nancy Kohlberg chair and
professor of medicine at Harvard Medical School and lead
investigator of ARC-20. “Based on these data, casdatifan has the
potential to be a future treatment option for kidney cancer. I am
particularly interested in planned research into novel combinations
for casdatifan in both first- and second-line ccRCC.”
“In the 100mg daily dose-expansion cohort of ARC-20, casdatifan
showed encouraging results, particularly a low primary progressive
disease rate and very durable responses. This was accomplished with
a manageable safety profile,” said Dimitry Nuyten, M.D., Ph.D.,
chief medical officer of Arcus. “These data support the potential
for casdatifan to be a best-in-class HIF-2a inhibitor for the
treatment of ccRCC. We look forward to initiating our first Phase 3
study for casdatifan, PEAK-1, in the first half of 2025, and
expanding our development program into the first-line setting with
a novel combination, as well as into other ccRCC
subpopulations.”
ARC-20 is a Phase 1/1b dose-escalation and -expansion study. In
the dose escalation (20mg to 200mg) portion of the study, the
safety profile was comparable across the doses; there were no
dose-limiting toxicities, and the maximum tolerated dose was not
reached at daily doses of up to 150 mg (200 mg portion of the study
is currently ongoing). The 100 mg daily dose (50 mg BID [twice
daily]) was selected for dose expansion, and casdatifan was
evaluated in patients with metastatic ccRCC who had progressed on
at least two prior lines of therapy, including both an anti-PD-1
and a tyrosine kinase inhibitor (TKI) therapy (n=33). The patient
population was heavily pre-treated: 52% had received at least three
prior lines of therapy; 26% had received at least four prior lines
of therapy; and 61% had an International Metastatic Renal Cell
Carcinoma Database Consortium (IMDC) risk factor of
intermediate.
At the time of data cut off (DCO, Aug. 30, 2024), median
follow-up was 11 months. Casdatifan showed a rapid time to
response, and only 19% of patients had primary progressive disease
(progressed at or before their first disease assessment). The
majority of patients (81%) experienced disease control with either
a partial response or stable disease. At the time of the DCO, the
median progression-free survival had not been reached. 34% of
patients experienced an objective response, meaning their tumor
shrank by at least 30%. A summary of initial results is below.
Objective Response Rate (ORR) per
RECIST v1.1
100mg Efficacy-Evaluable*
Population (n=32)
ORR
[95% CI]
34% (11)**
[16,50]
Responses Pending Confirmation
2**
Confirmed ORR
[95% CI]
25% (8)
[12,43]
Progressive Disease
19% (6)
Disease Control Rate
[95% CI]
81%
[64,93]
Median Progression-Free Survival
Not Reached
CI=confidence interval
*100mg daily dose is 50mg BID (twice
daily); efficacy-evaluable population for this expansion cohort is
defined as all eligible participants who have measurable disease at
baseline, receive at least one dose of casdatifan, and have at
least one post-baseline efficacy assessment, or who discontinue
study treatment due to progressive disease or death. One
participant was enrolled but deemed not eligible for the study and
was not evaluated for efficacy.
**One patient achieved a response after
DCO and nearly a year on treatment, which increased the ORR from
31% (10) to 34%.
In the 100mg dose-expansion cohort, no unexpected safety signals
were observed at the time of DCO, and casdatifan had an acceptable
and manageable safety profile. Grade 3 treatment-emergent adverse
events (TEAEs) related to casdatifan were 42%, including anemia
(36%) and hypoxia (9%). No patients discontinued treatment from
anemia. No TEAEs were life-threatening or led to death.
Arcus is pursuing a broad development program in both the
first-line and post-anti-PD-1 settings with differentiated
combinations to maximize the opportunity for casdatifan in ccRCC.
In addition to the monotherapy cohorts of ARC-20, the study is also
enrolling a cohort to evaluate casdatifan in combination with
cabozantinib, a VEGFR TKI which is intended to support the
initiation of Arcus’s planned first Phase 3 study, PEAK-1,
evaluating casdatifan in combination with cabozantinib versus
cabozantinib monotherapy in patients with metastatic ccRCC who have
previously received anti-PD-1 therapy. The primary endpoint will be
progression-free survival with a key secondary endpoint of overall
survival. Arcus also recently announced a clinical collaboration as
part of its first-line strategy in advanced ccRCC to evaluate
casdatifan in combination with volrustomig, an investigational
anti-PD-1/CTLA-4 bispecific antibody.
Investors may dial in to the conference call at +1 (404) 975-
4839 (local) or +1 (833) 470-1428 (toll-free), using Conference ID:
595409 on Thursday, October 24, 2024 at 5:00 AM PT / 8:00 AM ET.
Participants may also register for the call online using the
following link:
https://www.netroadshow.com/events/login?show=a0338351&confId=70796.
In addition to the ARC-20 data, the conference call will address
the development strategy and market potential for casdatifan. Arcus
will also be joined by Dr. Rana McKay of the University of
California San Diego. To access the live webcast and accompanying
slide presentation, please visit the “Investors & Media”
section of the Arcus Biosciences website at www.arcusbio.com. A
replay will be available following the live event.
About Casdatifan (AB521)
Casdatifan is a small-molecule inhibitor of HIF-2a, a
tumorigenic transcription factor involved in oxygen sensing in
multiple organs as well as in tumors. Clear cell RCC is almost
universally associated with HIF-2a dysregulation as a result of
genetic abnormalities in the VHL pathway. This creates a situation
of pseudohypoxia and the abnormal increase in HIF-2a-mediated
expression of a broad range of oncogenic proteins. By selectively
inhibiting HIF-2a, casdatifan is designed to disable a wide array
of pathways involved in tumor proliferation and survival, treatment
resistance and angiogenesis, leading to cancer cell death.
Casdatifan is being evaluated in ARC-20, a Phase 1/1b study in
cancer patients, and STELLAR-009, a Phase 1b/2 study in combination
with zanzalintinib in patients with advanced solid tumors,
including ccRCC.
Under the Gilead and Arcus collaboration agreement, Gilead has
the right to opt-in to development and commercialization for
casdatifan after Arcus’s delivery of a qualifying data package.
Casdatifan is an investigational molecule. Approval from any
regulatory authority for its use has not been received, and its
safety and efficacy have not been established.
About RCC
According to the American Cancer Society, kidney cancer is among
the top 10 most commonly diagnosed forms of cancer among both men
and women in the U.S., and an estimated 81,600 Americans will be
diagnosed with kidney cancer in 2024. Clear cell RCC is the most
common type of kidney cancer in adults. If detected in its early
stages, the five-year survival rate for RCC is high; for patients
with advanced or late-stage metastatic RCC, however, the five-year
survival rate is only 15%. In 2022, approximately 32,200 patients
with advanced kidney cancer required systemic therapy in the U.S.,
with over 20,000 patients receiving first-line treatment.
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, HIF-2a, CD73, dual A2a/A2b
receptor, CD39, and AXL. For more information about Arcus
Biosciences’ clinical and preclinical programs, please visit
www.arcusbio.com.
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.
Nuyten’s and Dr. Choueiri’s quotes and statements regarding: the
potency, efficacy or safety of casdatifan, including its potential
for a best-in-class profile; casdatifan’s safety profile; ability
for casdatifan to be used in first-line therapy; how data from
ARC-20 will support or advance Arcus’s development program for
casdatifan, including plans for future development; plans to
initiate a new Phase 3 study with casdatifan, including timing for
initiating any such study; and combinations that Arcus plans to
explore in future studies. 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; risks associated
with 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;
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.
The Arcus name and logo are trademarks of Arcus Biosciences,
Inc. All other trademarks belong to their respective owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20241024288665/en/
Investor Inquiries: Pia Eaves
VP of Investor Relations & Strategy (617) 459-2006
peaves@arcusbio.com
Media Inquiries: Holli Kolkey VP of Corporate
Communications (650) 922-1269 hkolkey@arcusbio.com
Arcus Biosciences (NYSE:RCUS)
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