Balstilimab Plus Zalifrelimab Data Published in Journal of Clinical Oncology (JCO)
23 December 2021 - 12:30AM
Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive
pipeline of checkpoint antibodies, adjuvants, and vaccines designed
to activate immune response to cancers and infections, today
announced the publication of results in the Journal of Clinical
Oncology (JCO) from a global Phase 2 clinical study of balstilimab
(Bal) plus zalifrelimab (Zal) in second-line (2L)
recurrent/metastatic cervical cancer patients who had relapsed
after treatment with platinum-based therapy.
“We’re excited to present this data from the largest study
conducted to date, assessing the benefit from combined PD-1 and
CTLA-4 inhibition in this patient population,” said Steven O’Day,
MD, Chief Medical Officer of Agenus. “The combination data with Bal
(anti-PD-1) and Zal (anti-CTLA-4) in recurrent/metastatic cervical
cancer represents a meaningful improvement over currently available
therapies while demonstrating a well-tolerated safety profile. We
are committed to pursuing the benefit of combination therapies with
first-generation antibodies like Zal as well as with our
next-generation candidates which include our Fc-enhanced
anti-CTLA-4 antibody AGEN1181.”
The trial showed that in the 125 evaluable patients treated with
Bal/Zal, ORR was 25.6%; among PD-L1+ patients, the ORR was 32.8%.
The Phase 2 trial was conducted in patients with
recurrent/metastatic cervical cancer who had relapsed after prior
platinum-based therapy, a population disproportionately represented
by younger women, who have limited effective treatment options.
Complete and partial responses were achieved by 8.0% and 17.6% of
all patients respectively. The disease control rate in the trial
was 52.0%. Responses achieved in patients were highly durable, with
a median duration of response not yet reached (NR) following
21-month median follow-up (95% CI: 9.7 months to NR). Median
overall survival was 12.8 months, with 69.2% and 53.3% of patients
remaining alive at 6 and 12 months, respectively. Responses were
observed across tumor histologies in the trial.
“With durable responses and a well-tolerated safety profile, the
combined inhibition of PD-1 and CTLA-4 is a much-needed option for
patients in this setting,” said David O’Malley, MD, lead study
investigator; Professor and Director of the Division of Gynecologic
Oncology, The Ohio State University - James Cancer Center.
The Bal/Zal combination continued to show no unexpected
toxicities and no new safety signals were identified. TRAEs leading
to discontinuations occurred in 7.7% of patients.
About Cervical CancerCervical cancer is a
malignancy that originates in the cervix, the lower part of the
uterus. It is the fourth most common cancer diagnosed among women
globally, with nearly 14,500 patients expected to be diagnosed in
the U.S. alone in 2021. Cervical cancer disproportionately affects
younger women and is most frequently diagnosed between the ages of
35 to 44 in the U.S., with the average age at diagnosis being 50.
Despite preventable measures such as HPV vaccination and early
pap-smear that exist for prevention and early detection of disease,
over 50% of cervical cancer cases in the U.S are only detected
after the disease has spread. In patients whose disease has spread
to distant parts of the body, 5-year survival rate in the U.S. is
estimated to be 17%. Nearly 4,300 women are expected to die from
cervical cancer in the U.S. in 2021.
About BalstilimabBalstilimab is a novel, fully
human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1
(programmed cell death protein 1) from interacting with its ligands
PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation
that is considered a foundational target within the immuno-oncology
market.
About ZalifrelimabZalifrelimab is a novel,
fully human monoclonal immunoglobulin G1 (IgG1) designed to block
CTLA-4 (cytotoxic T-lymphocyte associated antigen 4) from
interacting with its ligands CD80 and CD86. CTLA-4 is a negative
regulator of immune activation that is considered a foundational
target within the immuno-oncology market.
About AgenusAgenus is a clinical-stage
immuno-oncology company focused on the discovery and development of
therapies that engage the body's immune system to fight cancer. The
Company's vision is to expand the patient populations benefiting
from cancer immunotherapy by pursuing combination approaches that
leverage a broad repertoire of antibody therapeutics, adoptive cell
therapies (through its affiliate MiNK Therapeutics), adjuvants, and
proprietary cancer vaccine platforms. The Company is equipped with
a suite of antibody discovery platforms and a state-of-the-art GMP
manufacturing facility with the capacity to support clinical
programs. Agenus is headquartered in Lexington, MA. For more
information, please visit www.agenusbio.com and our Twitter handle
@agenus_bio. Information that may be important to investors will be
routinely posted on our website and Twitter.
Forward-Looking StatementsThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including
statements relating to the use of therapeutic candidates
balstilimab and zalifrelimab, for instance, statements regarding
therapeutic benefit and efficacy, mechanism of action, potency,
durability, and safety profile of balstilimab and zalifrelimab,
both alone and in combination with other agents, including
AGEN1181; future clinical development plans for balstilimab,
zalifrelimab, and AGEN1181, alone or in combination; and our
ability to obtain regulatory approval for balstilimab,
zalifrelimab, and AGEN1181, alone or in combination. These
forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially. These risks
and uncertainties include, among others, the factors described
under the Risk Factors section of our most recent Quarterly Report
on Form 10-Q or Annual Report on Form 10-K filed with the
Securities and Exchange Commission. Agenus cautions investors not
to place considerable reliance on the forward-looking statements
contained in this release. These statements speak only as of the
date of this press release, and Agenus undertakes no obligation to
update or revise the statements, other than to the extent required
by law. All forward-looking statements are expressly qualified in
their entirety by this cautionary statement.
ContactAgenus Inc.Divya
Vasudevan, PhD781-674-4571divya.vasudevan@agenusbio.com
Agenus Media RelationsKimberly HaKKH
Advisors917-291-5744kimberly.ha@kkhadvisors.com
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