Balstilimab Monotherapy Data Published in Gynecologic Oncology
August 26 2021 - 9:00AM
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an
extensive pipeline of checkpoint antibodies, cell therapies,
adjuvants, and vaccines designed to activate immune response to
cancers and infections, today announced that results from a global
Phase 2 clinical study of balstilimab monotherapy in
recurrent/metastatic cervical cancer were published online in the
international peer reviewed journal Gynecologic Oncology
(https://doi.org/10.1016/j.ygyno.2021.08.018).
“Publication of these data marks another significant achievement
toward our objective to provide effective therapeutic options to
those battling cancer,” said Steven O’Day, MD, Chief Medical
Officer of Agenus. “These data are drawn from the largest Phase 2
study to date evaluating PD-1 inhibition in advanced cervical
cancer patients who have progressed on or after first-line
chemotherapy; the results indicate balstilimab’s potential as an
effective new therapy.”
In the 140 evaluable patients, the objective response rate (ORR)
in patients with PD-L1 positive tumors was 20.0% and included 3
patients (3/85, 3.5%) with a complete response and 14 patients
(14/85, 16.5%) with a partial response. The median duration of
response (DoR) was not reached after a 14.6-month median follow-up.
Responses were also observed in the PD-L1 negative population with
an ORR of 7.9%. The confirmed ORR for both PD-L1 positive and
negative tumors was 15.0% and included 5 patients (3.6%) with a
complete response and 16 patients (11.4%) with a partial response.
The median DoR was 15.4 months and the disease control rate was
~50%. Notably, responses were observed across histologies, with
responses in the squamous cell histology (ORR 17.6%) and in the
more difficult to treat adenocarcinoma histology (ORR 12.5%). The
safety profile was manageable and consistent with that of currently
approved anti-PD-1 antibodies; it also compared favorably to the
safety profiles of chemotherapies used in this population. Data
from this trial continue to mature.
As discussed in the publication, these data suggest that
balstilimab may be a differentiated anti-PD-1 antibody as compared
to currently approved PD-1 inhibitors. In the KEYNOTE-158 trial of
pembrolizumab, an anti-PD-1 antibody, in the same setting, an ORR
of 14.6% was observed in the PD-L1 positive population and no
responses were observed in the PD-L1 negative population. In
addition, the noted 12.5% response rate of balstilimab in patients
with cervical adenocarcinoma is significant as this subpopulation
typically does not respond to immunotherapy and represents a
growing proportion of advanced cervical cancer cases. Balstilimab
thus provides the potential for therapeutic benefit to patient
populations that do not typically respond to currently-available
immunotherapy, both alone and in combination with other therapies,
such as Agenus’ anti-CTLA-4 antibodies zalifrelimab and AGEN1181.
Final results from a Phase 2 trial of balstilimab in combination
with zalifrelimab in advanced cervical cancer will be presented in
a Mini Oral Session at the European Society for Medical Oncology
(ESMO) Congress 2021 on September 19 from 11:35 – 11:40am ET by
David O’Malley, MD.
“The efficacy and safety of balstilimab provides additional
evidence of the importance of immune checkpoint blockade in the
treatment of recurrent, advanced cervical cancer patients,” said
David O’Malley, MD, Professor, Department of Obstetrics and
Gynecology, The Ohio State University College of Medicine;
Director, Division of Gynecologic Oncology, OSUCCC – James; and
lead author on the publication. “Furthermore, responses
to balstilimab were seen in patients who were PD-L1 positive,
PD-L1-negative, bevacizumab pre-treated, and squamous
cell and adenocarcinoma histologies. Balstilimab clearly provides
clinical benefit in a broad range of cervical cancer patients.”
Study Design
(NCT03104699)This was an
open-label, single-arm, global Phase 2 clinical trial conducted at
60 sites throughout the United States, Europe, South America, and
Australia. Patients were enrolled from November 20, 2017, to April
16, 2020, and received intravenous balstilimab at a dose of 3 mg/kg
once every two weeks, given as a 60-minute infusion. Treatment was
permitted for up to 24 months, or until disease progression,
intolerable toxicity, or investigator/patient decision.
About Balstilimab MonotherapyBalstilimab 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. Agenus announced it had submitted a
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) on April 19, 2021, for use in patients with
recurrent or metastatic cervical cancer, and the application is
under priority review with a target action date of December 16,
2021.
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 MiNK Therapeutics subsidiary), 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 regarding potential therapeutic benefit and future
clinical development plans for balstilimab, zalifrelimab, and
AGEN1181 alone and in combination with other agents. 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 Investor
RelationsJan Medina,
CFAAgenus781-674-4490Jan.Medina@agenusbio.com
Agenus Media RelationsKimberly
HaKKH Advisors917-291-5744kimberly.ha@kkhadvisors.com
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